Clinical Research Program
Department of Oncology
- McGill Studies List -ET 9001Phase I/II Study of Recombinant Human Interferon-Alpha, 5-FU and Cisplatin in Patients with
Disseminated Cancer
SCHERING CANADA
TERMINATED
Dr. M. Trudeau
-ET 9002Phase I/II Study of 5-FU, Leucovorin and Recombinant Interferon-Alpha in Patients with
Gastrointestinal Malignancies
HOFFMAN-LAROCHE
TERMINATED
Dr. M. Trudeau
-ET 9003Phase II Study of Tumor Necrosis Factor and Interleukin-2 for Patients with Melanoma
CETUS
NEVER
ACTIVATED
-ET 9004A Pilot Study Evaluating the Safety and Efficacy of Sandostatin Administered as a Single Agent and
in Combination with CB 205-50 in Metastatic Breast Cancer
SANDOZ
TERMINATED
Dr. M. Pollak
-ET 9005A Phase II Study of Mitoxantrone, Etoposide (VP-16) and Prednisone in Relapsed or Refractory
Non-Hodgkin’s Lymphoma
LEDERLE
TERMINATED
Dr. S. Caplan
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised: 2/17/2016
Page 2 of 121
McG Studies
-ET 90065-FU Plus Interferon-Alpha vs 5-FU Plus Leucovorin in Metastatic Colorectal Carcinoma
HOFFMAN-LAROCHE
TERMINATED
Dr. G. Batist
-ET 9007A Phase II Study of Doxo-Lipo Injection in Metastatic Breast Cancer
THERADEX
Dr. G. Batist
TERMINATED
-ET 9008A Pilot Study to Assess the Tolerance and Efficacy of Topically Applied Methotrexate in Patients
with Plaque Type Mucosis Fungoides
CATO-WHITBY
TERMINATED
Dr. B. Leyland-Jones
-ET 9009A Study of CGP-23339A (Disodium APD) Together with Chemotherapy in Metastatic Breast
Cancer Involving Bone
CIBA GEIGY CANADA
TERMINATED
Dr. G. Batist
-ET 9010A Pharmokinetic Study of Intravenous CGP-23339A (Disodium APD) in Cancer Patients
BIO-RESEARCH
Dr. G. Batist
TERMINATED
-ET 9011-
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
Phase III Multicenter Study of 10-Ethyl-10-Deazaminosterin (10-Edam) When Used in
Combination with Mitomycin and Vinblastine (EMV) versus Mitomycin and Vinblastine (MV) for
Treatment of Patients with Stage III or IV Non-Small Cell Lung Cancer
CIBA-GEIGY CANADA
TERMINATED
Dr. G. Batist
-ET 9012Phase II Study to Evaluate the Efficacy & Tolerance of a Combination of Vinblastine &
Recombinant IL-2 in the Treatment of Metastatic Renal Cell Carcinoma.
CETUS
TERMINATED
Dr. L. Panasci
-ET 9013Phase I Study of MTP-PE + 5FU & Leucovorin in Metastatic Colon Cancer
CIBA-GEIGY CANADA
TERMINATED
Dr. G. Batist
-ET 9014Phase I Study of Once Daily Buthionine Sulfoximinine (BSO) in Patients Receiving Localized
Radiotherapy
THERADEX-MONITOR
TERMINATED
Dr. G. Batist/Wendy Kerby
-ET 9015A Phase II Multicenter Clinical Trial to Evaluate the Safety and Efficacy of a Single Administration
Every Three Weeks (q3w) Schedule of DuP 937 in Cancer Patients with Refactory Solid Tumors
DUPONT PHARMA
TERMINATED
Drs. J. Viallet & L. Panasci
-ET 9016-
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
A Pharmacodynamic Assessment of r-metHuG-CSF Schedule Variation in Patients with Small Cell
Lung Cancer Given CEA-Chemotherapy
AMGEN
TERMINATED
Dr. J. Viallet
-ET 9101A Phase II Trial of Neupogen (r-met-HuG-CSF) as an Adjunct to ProMACE-CytoBOM
Combination Chemotherapy in Intermediate or High Grade Non-Hodgkin’s Lymphoma.
AMGEN
TERMINATED
Dr. C. Shustik
-ET 9102Stereotactic Radiosurgery and External Beam Accelerated Fractionation for High-Grade Cerebral
Astrocytomas: A Phase I/II Study
NO SPONSORSHIP
TERMINATED
Dr. G. Shenouda
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
-ET 9103A Randomized Study of Moderately Intensive Chemotherapy and Autologous Bone Marrow
Rescue, as Initial Therapy for Stage III and IV Epithelial Ovarian Cancer Incorporating the Study of
ORG 2766 in the Prevention or Delay of Cisplatinum Induced Neuropathies in Patients with
Ovarian Cancer
ORGANON
TERMINATED
Dr. A. Langleben
-ET 9104Open, Randomized Dose-Finding Study of Gallium Nitrate Administered Intravenously (200 or 400
mg/M2/D) in Malignant Hypercalcemia
FUGISAWA
TERMINATED
Drs. B. Leyland-Jones & M. Thirlwell
-ET 9105A Phase I Study of Consecutive 4 Daily Doses of Mitoxantrone with GM-CSF in Patients with
Advanced Cancer
SCHERING CANADA
TERMINATED
Dr. G. Batist
-ET 9106A Phase I Dose Escalation Study of cyclophosphamide in Combination with Cisplatin and G-CSF in
Advanced Ovarian Cancer
SCHERING CANADA
TERMINATED
Dr. M. Trudeau
-ET 9107-
Droloxifene 100 mg O.D. versus Tamoxifen 30 mg O.D. as Initial Sole Treatment in Elderly
Patients with Stage I, II and III Breast Cancer: A Double-Blind, Controlled Comparative Study.
RHONE-POULENC RORER
TERMINATED
Dr. H. Shibata
-ET 9108-
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
A Randomized Trial Comparing Intravenous Navelbine with 5-Fluorouracil/Leucovorin for the
Treatment of Inoperable, Previously Untreated, Stage IV Non-Small Cell Lung Cancer
BURROUGHS WELLCOME
Dr. J. Viallet
TERMINATED
-ET 9109A Phase II Multicenter Clinical Trial to Evaluate the Safety and Efficacy of a Single Administration
Every Three Weeks (q3W) Schedule of DuP-941 in Cancer Patients with Advanced Breast Cancer
DUPONT PHARMA
TERMINATED
Dr. L. Panasci
-ET 9110A Phase III Evaluation of Tamoxifen Alone or Combined with a Somatostatin Analogue in Women
with Metastatic Breast Cancer
MAYO CLINIC
TERMINATED
Dr. M. Pollak
-ET 9111Tamoxifen in Recurrent High Grade Cerebral Astrocytomas: A Phase I/II Study
NO SPONSORSHIP
Dr. G. Shenouda
TERMINATED
-ET 9112A Randomized Phase III Efficacy and Safety of Recombinant Human Granulocyte Colony
Stimulating Factor (r-metHuG-CSF) in Patients with Myelodysplastic Syndromes
AMGEN
Dr. S. Caplan
TERMINATED
-ET 9201-
[CDN - 106]
A Phase II Trial of MIC in Gynecologic Pelvic Malignancies
BRISTOL-MYERS SQUIBB
Dr. M. Trudeau
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
TERMINATED
Revised:
2/17/2016
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McG Studies
-McG 9202The Effect of Subcutaneous r-HuEPO in Patients with Chronic Lymphocytic Leukemia
ORTHO-MCNEIL
Dr. C. Shustik
TERMINATED
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
-McG 9203Gallium Nitrate for Induction and Maintenance Treatment of Cancer-Related Hypercalcemia: A
Five Day Regimen of Intravenous Infusion Followed by Daily Subcutaneous Administration
FUJISAWA
Dr. B. Leyland-Jones
NEVER ACTIVATED
-McG 9204Phase III Trial to Evaluate Treatment of Patients with Oesophagus Cancer with Chemotherapy and
Radiotherapy Compared to Surgery Alone
NO SPONSORSHIP
NOT PARTICIPATING
Dr. T. Vuong
-McG 9205Comparison of TLC D-99 Doxorubicin Liposome Injection versus Doxorubicin in Metastatic Breast
Cancer
PFIZER CANADA
TERMINATED
Dr. G. Batist
-McG 9206Efficacy and Safety Trial of Toremifene vs Tamoxifen in Post-Menopausal Patients with Metastatic
Breast Cancer
ADRIA
TERMINATED
Dr. L. Panasci
-McG 9207Idarubicin for Previously Treated Low Grade Non-Hodgkin’s Lymphoma: A Phase II and
Population Pharmacodynamics Study
ADRIA
TERMINATED
Drs. S. Caplan & B. Leyland-Jones
-McG 9208A Phase I/II Trial of Chemotherapy with Cisplatin and Navelbine Followed by Accelerated Thoracic
Irradiation in Inoperable Non-Small Cell Lung Cancer
BURROUGHS WELLCOME
TERMINATED
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
Dr. J. Viallet
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
-McG 9209A Phase II Trial of Sandostatin in the Treatment of Advanced Colorectal Cancer
SANDOZ
Dr. M. Pollak
TERMINATED
-McG 9210A Phase II Trial of Sandostatin in the Treatment of Estrogen Receptor (ER)-Positive Advanced
Breast Cancer
SANDOZ
TERMINATED
Dr. M. Pollak
-McG 9211A Phase II Trial of Sandostatin in the Treatment of Estrogen Receptor (ER)-Negative Advanced
Breast Cancer
SANDOZ
TERMINATED
Dr. M. Pollak
-McG 9301-
A03-M02-93
A Phase I Dose Finding Clinical Trial to Evaluate the Safety, Efficacy and Pharmacokinetics of DuP
941 (Losoxantrone) in Combination with Cyclophosphamide Given Every Three Weeks (Q3W) in
Patients with Advanced Breast Cancer
DUPONT
TERMINATED
Dr. L. Panasci
-McG 9302-
A04-M06-93
A Trial of Neupogen® (recombinant-methionyl human granulocyte colony stimulating factor) as an
Adjunct to CHOP Combination Chemotherapy in Patients, Over 65 Years of Age, with Intermediate
or High Grade Non-Hodgkin’s Lymphoma
AMGEN
TERMINATED
Dr. S. Caplan
-McG 9303-
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
A03-M07-93
Revised:
2/17/2016
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McG Studies
Open, Multicenter, Comparative Trial of CGP 32 349 I.M. Depot versus Oral Megestrol Acetate as
Second-Line Therapy in Post-Menopausal Patients with Advanced Breast Cancer After 1st-Line
Therapy with Tamoxifen
CIBA-GEIGY CANADA
TERMINATED
Dr. C Panasci
-McG 9304A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose Finding/Efficacy/Safety
Study of ORG 2766 in the Prevention or Amelioration of Vincristine-Induced Neuropathies in
Patients with Hodgkin’s or Non-Hodgkin’s Lymphoma
ORGANON INC.
NEVER ACTIVATED
Dr. A. Langleben
-McG 9305-
A10-M21-93
Non Purged Autologous Bone Marrow Transplant Protocol for Failed Intermediate and High Grade
Non Hodgkin’s Lymphoma
NO SPONSORSHIP
TERMINATED
Dr. G. Blake
-McG 9306-
[AR/Bc2]
A08-M22-93
Double-Blind, Randomized, Multicenter, Comparative, Between Patient Phase II Trial Comparing
Daily Doses of 0.5 MG CGS 20 267 Versus 2.5 MG CGS 20 267 Versus 160 MG Megestrol
Acetate as Second-Line Endocrine Therapy in Postmenopausal Patients with Advanced Breast
Cancer
CIBA-GEIGY
TERMINATED
Drs. L. Panasci & D. Melnychuk
-McG 9307-
A05-M26-93
A Phase II Study of Tallimustine in Patients with Advanced Epithelial Cancer of the Ovary
ADRIA LABORATORIES
Dr. M. Trudeau
TERMINATED
-McG 9308-
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
A12-M30-93
Revised:
2/17/2016
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McG Studies
A Phase II Study of Antitumor Efficacy of Tallimustine in Adult Patients with
Metastatic/Unresectable NSCLC
ADRIA LABORATORIES
NEVER ACTIVATED
Dr. J. Viallet
-McG 9309Clinical Investigation of 5-Fluorouracil Dose Intensification with IL3 (ILE 964) and GM-CSF
(Leucomax) in Patients with Gastrointestinal Cancer
SANDOZ
WITHDRAWN
Dr. G. Batist
-McG 9310-
A02-M34-93
A Phase II Study of Sequential, Response-Adapted Induction Regimens Idarubicin/Cytarabine and
Mitoxantrone/Etoposide, for Treatment of de novo Acute Myelogenous Leukemia in Adult Patients
PHARMACIA / Adria
TERMINATED
Dr. C. Shustik
-McG 9311-
A12-M35-93
Fludarabine Phosphate Versus CVP in Previously Treated Patients with Progressive Low Grade
Non-Hodgkin's Lymphomas
BERLEX
TERMINATED
Drs. C. Shustik & L. Lacroix
-McG 9401-
[I91-106-78]
A03-M01-94
Phase III Randomized Controlled Trial Comparing the Efficacy of Combination Therapy with 5
Fluorouracil and Cisplatin Against the Efficacy of Combination Therapy with 5 Fluorouracil,
Cisplatin and Intron A® in the Treatment of Recurrent or Metastatic Cancer of the Head and Neck
SCHERING CANADA INC.
TERMINATED
Dr. M. Trudeau
-McG 9402-
[MAZ 004-01]
A Pilot Study of Topically-Applied Methotrexate/Azone® (MTX/AZ) in Patients with Early Stage
Mycosis Fungoides (A Phase II Study to Assess the Tolerance and Efficacy of Topically-Applied
Methotrexate with Azone in Patients with Plaque-Type Mycosis Fungoides)
FDA ORPHAN GRANT/CATO RESEARCH
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
Dr. B. Leyland-Jones/Ida Salera
-McG 9403-
2nd Review
[930206]
TERMINATED
A05-M05-94
A Pilot Study of High Dose Intensity Chemotherapy and Irradiation with G-CSF (Neupogen) in
Patients with Limited Disease Small Cell Lung Cancer
AMGEN
TERMINATED
Dr. V. Hirsh/Wendy Kerby
-McG 9404-
[1694IL/0010:0043]
A08-M09-94
An Open, Randomized Multicenter Trial of TomudexTM (ZD1694) versus 5-Fluorouracil (5-FU)
and Leucovorin (LV) in Patients with Advanced Colorectal Carcinoma
ZENECA
Dr. M. Thirlwell/Wendy Kerby
TERMINATED
-McG 9405-
[TAX295 (CTX1993)]
A05-M10-94
Phase II Trial with Docetaxel in Patients with Metastatic and/or Locally Advanced Non-Small Cell
Lung Cancer
RHONE-POULENC
TERMINATED
Dr. V. Hirsh/Wendy Kerby
-McG 9406-
[DMP 840-007-003]
A05-M12-94
A Phase II Multicenter Clinical Trial to Evaluate the Safety, Efficacy and Pharmacokinetics of DMP
840 Given Every Four Weeks (Q4W) in Patients with Advanced Refractory Breast Cancer
DU PONT MERCK PHARMA
Dr. L. Panasci/Helen Charamis
TERMINATED
-McG 9407-
[GCSF-930261]
A08-M15-94
A Phase II Study of Filgrastim-Mobilised Peripheral-Blood Cell Transplantation in Patients with
Poor Prognosis Intermediate and High Grade Non-Hodgkin's Lymphoma
AMGEN
TERMINATED
Dr. L. Lacroix/Wendy Kerby
-McG 9408-
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
A Phase I/II Study of SDZ PSC 833 with Doxorubicin, Vincristine, Cyclophosphamide and
Prednisone in Patients with Refractory or Relapsed Non-Hodgkin’s Lymphoma
SANDOZ
WITHDRAWN
Dr. C. Shustik
-McG 9409-
[02]
A09-M23-94
Letrozole (CGS 20267) Comparison of two Doses (0.5 mg and 2.5 mg) of Letrozole (CGS 20267)
versus Megestrol Acetate in Post-Menopausal Women with Advanced Breast Cancer
CIBA-GEIGY
TERMINATED
Dr. L. Panasci/Helen Charamis
-McG 9410-
[RP 56976-V-304]
A10-M24-94
A Randomized Phase III Multicenter Trial Comparing Docetaxel (Taxotere®) as Single Agent to
Mitomycin C in Combination with Vinblastine in Patients with Metastatic Breast Cancer who have
Failed an Anthracycline Containing Regimen
RHONE-POULENC RORER
TERMINATED
Dr. D. Melnychuk/Helen Charamis
-McG 9411-
[94CE32-0652]
A11-M25-94
Phase III Comparative Study of Combination Treatment with TLC D-99 Liposomal Doxorubicin
and Cyclophosphamide versus Doxorubicin and Cyclophosphamide in Metastatic Breast Cancer
PFIZER, INC.
TERMINATED
Dr. G. Batist/Helen Charamis
-McG 9501[]
A03-M03-95
Adjuvant Tamoxifen and Postoperative Radiotherapy in Patients with Newly Diagnosed
Glioblastoma Multiforme: A Phase I Study Correlating Biological and Biochemical Markers with
Clinical Response
TBA
TERMINATED
Dr. G. Shenouda/Pat Nikoloulias
-McG 9502Phase II Trial with Sequential Administration of Docetaxel, Cisplatin and Vinorelbine in Patients
with Non-Small Cell Lung Cancer
RHONE-POULENC RORER
WITHDRAWN
Dr. J. Viallet
-McG 9503-
[TAX 303]
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
A03-M05-95
Revised:
2/17/2016
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McG Studies
A Randomized Phase III Trial Comparing Docetaxel (Taxotere®) to Doxorubicin in Patients with
Metastatic Breast Cancer who Have Failed an Alkylating Containing Regimen
RHONE-POULENC RORER
Dr. F. Patenaude/Helen Charamis
TERMINATED
-McG 9504-
[-]
A03-M08-95
Correlation of BCNU Response with Molecular Markers in the Tumor of Patients with High Grade
Gliomas
NO SPONSORSHIP
TERMINATED
Dr. L. Panasci/Pat Nikoloulias
-McG 9505-
[H0649g]
A03-M09-95
A Phase III Multinational, Open-Label Study of Recombinant Humanized Anti-p185HER2
Monoclonal Antibody (rhuMAb HER2) in Patients with HER2/neu Overexpression who have
Relapsed Following Two Chemotherapy Regimens for Metastatic Breast Cancer
GENENTECH
TERMINATED
Dr. M. Pollak/Angela McQuillan
-McG 9506-
[940EPH31]
A03-M10-95
Dose Intensification Therapy for Breast Cancer Management
PHARMACIA INC.
Dr. A. Langleben/Bev DeSalis
TERMINATED
-McG 9506-PK-
A04-M19-95
Dose Intensification Therapy for Breast Cancer Management
TBA
Dr. A. Langleben/Bev DeSalis
-McG 9506-DNA-
TERMINATED
A00-M31-96
Characterization of Genetic Changes Associated with Tumor Progression Following Chemotherapy
NO SPONSORSHIP
TERMINATED
Dr. Jerry Pelletier
-McG 9506-POLY-
A00-M39-96
Polymorphism Analysis and correlation of Responsiveness to Chemotherapy
NO SPONSORSHIP
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
TERMINATED
Revised:
2/17/2016
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McG Studies
Dr. Brian Gilfix
-McG 9507-
[I94 - 048 – 03]
A04-M13-95
An Open-Label Phase II Dose Ranging Study of SCH 39400 (rHuIL-4) in Advanced Non-Small
Cell Lung Cancer (Stage IIIB and IV)
SCHERING-PLOUGH
TERMINATED
Dr. S. Burdette-Radoux/Francis Doyle
-McG-9507-E-
[I95 - 100 – 03]
A03-M09-96
Open-Label Extended Administration of SCH 39400 (rHuIL-4) in Advanced Non-Small Cell Lung
Cancer (Stage IIB and IV)
SCHERING-PLOUGH
TERMINATED
Dr. S. Burdette-Radoux/Francis Doyle
-McG 9508-
[CDA94 – 001]
A Phase II Study of 2-Chloroadenosine in Previously Treated CLL
ORTHO-McNEIL
Dr. C. Shustik/Barbara Adamska
-McG 9509-
[IDEC - C2B8 - #102 – 05]
A06-M14-95
TERMINATED
A04-M15-95
Pivotal Phase II Multi-Center Study to Evaluate the Safety and Efficacy of Once Weekly Times
Four Dosing of IDEC-C2B8 (IDEC-102) in Patients with Relapsed Low-Grade or Follicular B-Cell
Lymphoma
IDEC
TERMINATED
Dr. S. Caplan
-McG 9510-
[I94 - 123 – 06]
A04-M16-95
A Phase II Study of Temozolomide (SCH 52365) in the Treatment of Patients with Anaplastic
Astrocytoma at First Relapse
SCHERING-PLOUGH
TERMINATED
Dr. J-G. Villemure
-McG 9511[I94 - 122 – 06]
A04-M61-95
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
A Phase II Study of Temozolomide (SCH 52365) in the Treatment of Patients with Glioblastoma
Multiforme at First Relapse
SCHERING-PLOUGH
TERMINATED
Dr. J-G. Villemure
-McG 9512-
[C03/IVB/109]
A07-M32-95
An Early Phase II Dose-Escalation Study of BB-2516 in Patients with Advanced Pancreatic Cancer
BRITISH BIOTECH
TERMINATED
Dr. A. Langleben
-McG 9512-E-
[CO3/IVB/112]
A07-M33-95
An Open Label Extended Use Study of BB-2516 in Patients with Advanced Refractory Cancer
Previously Exposed to BB-2516
BRITISH BIOTECH
TERMINATED
Dr. A. Langleben
-McG 9513-
[590 75 – 105]
A05-M21-95
A Phase II, Non-Randomized, Open-Label Multiple Dose Study Assessing the Efficacy and Safety
of the Combination of Radiotherapy Plus Intravenously Administered Tirapazamine in Subjects
with Advanced Squamous Cell Carcinoma of the Head and Neck
SANOFI WINTHROP
TERMINATED
Dr. G. Shenouda
-McG 9514-
[-]
A09-M38-95
Phase I and Pharmacokinetic Study of R-Ifosfamide as a Single Stereoisomer
CHIROSCIENCE LTD.
Dr. G. Batist
TERMINATED
-McG 9515-
A05-M22-95
[H0648g]
A Phase III Multinational, Randomized Study of Recombinant Humanized Anti-p185HER2
Monoclonal Antibody (rhuMAb HER2) Combined with Chemotherapy in Patients with HER2
Overexpression who have not Receive Cytotoxic Chemotherapy for Metastatic Breast Cancer
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
GENENTECH
Dr. B. Leyland-Jones
-McG 9515-E-
TERMINATED
[0659g]
A03-M48-95
An Open-Label Extension Study with Recombinant Humanized Anti-p185HER2 Monoclonal
Antibody (rhuMAb HER2) for Patients whose Metastatic Breast Cancer Progressed During
Treatment on Protocol H0648g
GENENTECH
TERMINATED
Dr. B. Leyland-Jones
-McG 9516-
[C03/111]
A09-M42-95
A Phase I/II Open-Label Dose-Escalation Study of BB-2516 in Patients with Serologically
Progressing Prostate Cancer
BRITISH BIOTECH
TERMINATED
Dr. A. Langleben
-McG 9517-
[IX - 108 – 081]
A10-M43-95
A Phase II/III Trial of a 3-Hour Infusion of Paclitaxel from NaPro/Baker Norton in Patients with
Refractory Ovarian Cancer with Crossover to a 96-Hour Infusion on Failure
BAKER NORTON PHARMACEUTICALS INC.
TERMINATED
Dr. M. Trudeau
-McG 9518Phase II Randomized Clinical Trial Comparing Two Dose-Schedules of Idarubicin, in Combination
Chemotherapy Including Cyclophosphamide, Vincristine, and Prednisone (CIOP) in the Treatment
of Intermediate and High Grade Non-Hodgkin's Lymphoma with High Risk Factors
PHARMACIA
COMPANY WITHDRAWN
Dr. C. Shustik
-McG 9519Phase II Multi-Center Study to Evaluate the Safety and Efficacy of Once Weekly Times Four
Dosing of IDEC-C2B8 (IDEC-102) in Selected Patients with Low-Grade or Follicular B-Cell
Lymphoma
IDEC
WITHDRAWN
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
Dr. S. Caplan
-McG 9520-
[GLIB 201]
A02-M55-95
Gene Therapy for the Treatment of Glioblastoma Multiforme with In Vivo Tumor Transduction
with the Herpes Simplex Thymidine Kinase Gene/Ganciclovir System
SANDOZ
TERMINATED
Drs. R. Leblanc & P. Laneuville
-McG 9521-
[NCI T95-0008]
A01-M57-95
A Phase II Trial of IV L-PAM and BSO in Patients with Relapsed or Refractory Ovarian Cancer
NO SPONSORSHIP
TERMINATED
Dr. Batist
-McG 9522-
[H0650g]
A Multinational, Randomized, Single-Blind Study of Recombinant Humanized Anti-p185HER2
Monolconal Antibody (rhuMAb HER2) in Patients with HER2/neu Overexpression who have not
Received Prior Cytotoxic Chemotherapy for Metastatic Breast Cancer
GENENTECH
Dr. B. Leyland-Jones
NOT PARTICIPATING
-McG 9601-
[566/010 (157 - 001)]
A03-M03-96
A Prospective, Randomized, Multicenter Phase III Clinical Trial Comparing the Effects of Panorex
 (17-1A Monoclonal Antibody) Injection Plus 5-Fluorouracil-Based Chemotherapy versus 5Fluorouracil-Based Chemotherapy Alone in Patients with Surgically Resected Stage III Carcinoma
of the Colon
GLAXO WELLCOME
TERMINATED
Dr. M. Thirlwell
-McG 9602-
[1033IL / 0030:0084]
A06-M12-96
A Randomized, Double-Blind Trial to Compare the Efficacy and Safety of Anastrozole (Arimidex
1mg Daily) as First-Line Therapy for Advanced Breast Cancer in Postmenopausal Women
ZENECA
TERMINATED
Dr. M. Pollak
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
-McG 9603-
[073049]
A09-M13-96
A Randomized Trial on the Efficacy of Non-Cross Resistant, Consolidation Therapy versus High
Dose Cytosine Arabinoside Consolidation chemotherapy Following Sequential Response-Adapted
Induction Treatment for Adult Acute Myelogenous Leukemia
PHARMACIA
TERMINATED
Dr. Chaim Shustik
-McG 9604-
[CA95002]
A04-M14-96
Phase II Study of Vincristine Sulfate Liposome Injection in Metastatic Colorectal Carcinoma
INEX
Dr. G. Batist/Pat Nikoloulias
TERMINATED
-McG 9605-
[CA95001]
A04-M15-96
Phase II Study of Vincristine Sulfate Liposome Injection in Carcinoma of the Pancreas
INEX
Dr. G. Batist
TERMINATED
-McG 9606-
[MGDF - 951019 – 28]
A05-M16-96
A Comparative, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohort, DoseExcalation, Efficacy and Safety Study of Pegylated Recombinant Human Megakaryocyte Growth
and Development Factor (PEG-rHuMGDF) in Patients with Delayed Platelet Engraftment After
Autologous bone Marrow or Peripheral Blood Progenitor Cell Transplantation
AMGEN
Dr. A. Langleben
TERMINATED
-McG 9606-F-
[MGDF - 951005 – 28]
A09-M35-96
A Long-Term Follow-Up Study of Patients who were Previously Enrolled in Amgen-Sponsored
Clinical Trials Using Pegylated Recombinant Human Megakaryocyte Growth and Development
Factor (PEG-rHuMGDF)
AMGEN
TERMINATED
Dr. A. Langleben
-McG 9607-
[CBMTG 96-01]
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
A Study to Compare Peripheral Blood Progenitor Cells Versus Bone Marrow in Patients having
Matched Sibling Allogeneic Transplants for Acute Myeloid Leukemia, Chronic Myeloid Leukemia
and Myelodysplastic Syndrome
CBMTG
WITHDRAWN
Dr. P. Laneuville
-McG 9608-
[259075 - 205 (ERC 2753)]
A07-M22-96
A Phase III, Two-Armed, Multi-Center, Randomized, Controlled Comparison of the Efficacy of
Cisplatin Alone versus Cisplatin and Tirapazamine in Subjects with Advanced (Stage IIIB and IV),
Previously Untreated, Non-Small Cell Lung Tumours (Catapult)
SANOFI WINTHROP
TERMINATED
Dr. V. Hirsh
-McG 9609-
[ERC – 103]
A07-M23-96
Effect of Rising EM 800 Dose in Breast Cancer Relapsing after an Initial Response to Tamoxifen or
in Patients Showing Progression After Tamoxifen Given as Adjuvant to Surgery: Phase I/II
CHUL
Dr. M. Pollak
TERMINATED
-McG 9610-
[PRI/EPO - CAN – 3]
A07-M24-96
Clinical Evaluation of the Safety and Efficacy of EPREX Sterile Solution (epoetin alfa) in the
Treatment of Anemia in Cancer Patients
ORTHO-McNEIL
TERMINATED
Dr. S. Burdette-Radoux
-McG 9611A Phase II Study of DAB389IL-2, an Interleukin-2 Fusion Toxin, for Previously Untreated Stage II,
III, and IV Follicular Low-Grade Non-Hodgkin’s Lymphoma
ELI LILLY
WITHDRAWN
Dr. L. Lacroix
-McG 9612-
[TAx 701 (CTX 2195)]
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
Phase II Trial with Alternating Administration of Docetaxel and Vinorelbine as First Line Therapy
for Patients with Metastatic Breast Cancer having Received Prior Anthracyclines as Adjuvant or
Neoadjuvant Therapy
RHONE-POULENC & GLAXO-WELLCOME
COMPANY
WITHDRAWN
Dr. L. Panasci
-McG 9613-
[SP-BC-01]
A Randomized, Double-Bind, Multicenter Study of Low-Dose Gallium Nitrate for Treatment of
Bone Metastases Due to Breast Cancer
SOLOPAK
NOT PARTICIPATING
Dr. B. Leyland-Jones
-McG 9614-
[TX - 111 – 081]
A08-M32-96
Phase II Trial of 96-Hour Infusion of Paclitaxel BNP from NaPro/Baker Norton in Patients with
Advanced Ovarian Carcinoma Refractory to Short Infusion Taxan Therapy
BAKER NORTON
TERMINATED
Dr. M. Trudeau
-McG 9615-
A09-M33-96
Bone Marrow Transplantation for Aplastic Anemia: A Randomized Controlled Study of Two
Conditioning Regimens
INTERNATIONAL BONE MARROW TRANSPLANT REGISTRY
TERMINATED
Dr. P. Laneuville
-McG 9616-
A07-M34-96
Sarcoma Tumour Bank/Correlative Clinical Data Base
(CANADIAN SARCOMA GROUP)
Dr. C. Freeman
-McG 9617-
[M6475-0038]
CLOSED
A10-M40-96
A Phase III, Randomized, Controlled Clinical Trial of Irinotecan HCI (CPT-11) Alone, Combined
Irinotecan HCI and 5-Fluorouracil Plus Leucovorin, and 5-Fluorouracil Plus Leucovorin Alone in
Patients with Untreated Metastatic Colorectal Cancer
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
UPJOHN
Dr. M. Trudeau
-McG 9618-
TERMINATED
[GTI – 0115]
Prospective, Open-Label, Parallel-Group, Randomized, Multicenter Trial Comparing the Efficacy of
Surgery, Radiation, and Injection of Murine Cells Producing Herpes Simplex Thymidine Kinase
Vector Followed by Intravenous Ganciclovir Against the Efficacy of Surgery and Radiation in the
Treatment of Newly Diagnosed, Previously Untreated Glioblastoma
SANDOZ
Dr. R. Leblanc
TERMINATED
-McG 9619-
[EM 800/ERC 106]
Effect of EM-800 in Breast Cancer not Responding to Endocrine Therapy or With Negative ER:
Prospective Double-Blind Trial
CHUL
WITHDRAWN
Dr. M. Pollak
-McG 9620-
[CO3/IVB/128]
A02-M44-96
A Pivotal Randomized Controlled Study Comparing Marimastat Against Gemcitabine as First Line
Therapy in Patients with Non-Resectable Pancreatic Cancer
BRITISH BIOTECH
TERMINATED
Dr. A. Langleben
-McG 9621-
[S014695]
A12-M53-96
An Open-Label Randomized Phase III Study Comparing Capecitabine Therapy with 5-Fluorouracil
in Combination with Leucovorin as First-Line Therapy in Patients with Advanced and/or Metastatic
Colorectal Cancer
HOFFMANN-LA ROCHE
TERMINATED
Dr. G. Batist
-McG 9622-
[PSCB 253-E-00]
A02-M54-96
A Phase II Efficacy, Tolerability and Safety Study of Vincristine, Doxorubicin, Dexamethasone
(VAD) and SDZ PSC 833 Therapy in Patients with VAD-Refractory Multiple Myeloma
SANDOZ
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
Dr. C. Shustik
TERMINATED
-McG 9623Rabbit Anti-Thymocyte Globulin in the Management of Steroid-Resistant Graft-versus Host
Disease: A Canadian Multicenter Phase I/II Study
TBA
COMPANY WITHDRAWN
Dr. P. Laneuville
-McG 9701-
[PROTOCOL #080]
A03-M01-97
An Open-Label, Randomized, Comparative, Multicenter Phase III Study of Oral vs Intravenous
Topotecan as a Single Agent, Second-Line Therapy Administered for Five Days in Patients with
Advanced Ovarian Cancer
SMITHKLINE BEECHAM
TERMINATED
Dr. M. Trudeau
-McG 9702-
[564/040 (FUMA 2003)]
A04-M03-97
A Phase II Open-Label Study to Evaluate a 28-Day Regimen of Oral 5-Fluorouracil (5-FU) Plus
776C85 for the Treatment of Patients with Taxane-Resistant Advanced Breast Cancer
GLAXO WELLCOME
TERMINATED
Dr. M. Thirlwell
-McG 9703A Phase III, Two-Armed, Multi-Center, Randomized, Controlled Comparison of the Efficacy of
Cisplatin and Etoposide (VP-16) versus Cisplatin and Tirapazamine in Subjects with Advanced
(Stage IIIB and IV), Previously Untreated, Non-Small Cell Lung Tumors (CATAPULT II)
SANOFI WINTHROP
Dr. V. Hirsh
NOT PARTICIPATING
-McG 9704-
[2026701025]
A05-M07-97
Double-Blind, Double Dummy, Randomized, Multicenter, 3-Arm, Phase III Trial Comparing
Letrozole 2.5 mg versus Tamoxifen 20 mg versus the Combination of Letrozole + Tamoxifen as
First-Line Therapy in Postmenopausal Women with Advanced Breast Cancer
NOVARTIS
TERMINATED
Dr. L. Panasci
-McG 9705[L1057-77]
A06-M06-97
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
A Phase III Randomized, Controlled Trial Evaluating the Efficacy of Panretin (ALRT1057;9-cisRetinoic Acid) Capsules in Patients with Newly Diagnosed Acute Promyelocytic Leukemia
LIGAND
Dr. W. Miller
TERMINATED
-McG 9706-
[PSC C 302-E-00]
A09-M08-97
An Open Label, Randomized Controlled Study in Elderly Subjects with Previously Untreated Acute
Myelogenous Leukemia, Comparing Treatment Groups Randomized to Either Daunorubicin and
Cytarabine or to Daunorubicin, Cytarabine and PSC 833
NOVARTIS
TERMINATED
Dr. C. Shustik
-McG 9707Camptosar (Irinotecan) Protocol for 5-Fluorouracil Refractory Colorectal Cancer at Established
Trial Sites. (Guidelines for Named Patient Treatment)
PHARMACIA & UPJOHN
WITHDRAWN
Dr. M. Trudeau
-McG 9708Prospective, Open-Label, Multicenter, Extension Trial for the Treatment of Recurrent Glioblastoma
Multiforme with Surgery and Injection of Murine Cells Producing Herpes Simplex Thymidine
Kinase Vector Followed by Intravenous Ganciclovir for Patients with Disease Progression
Following Standard Treatment on Protocol GTI-0115
NOVARTIS
COMPANY WITHDRAWN
Dr. R. Leblanc
-McG 9709-
[C03/IVB/131]
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Trial of Marimastat in Patients
with Glioblastoma Multiforme or Gliosarcoma Following Completion of Conventional First-Line
Treatment
BRITISH BIOTECH
TERMINATED
Dr. A. Langleben
-McG 9710-
[1033IL/0029]
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
A05-M19-97
Revised:
2/17/2016
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McG Studies
A Randomized, Double-Blind Trial Comparing ARIMIDEX Alone with NOLVADEX Alone with
ARIMIDEX and NOLVADEX in Combination, as Adjuvant Treatment in Postmenopausal Women
with Breast Cancer
ZENECA PHARMA
CLOSED
Dr. L. Panasci
-McG 9710-QOL- [1033IE/0029]
A Randomized, Double-Blind, Parallel-Group Trial to Assess Quality of Life with Arimidex®
Alone, Nolvadex™ Alone, or Arimidex® and Nolvadex in Combination, When Used as Adjuvant
Treatment for Breast Cancer in Postmenopausal Women
ZENECA PHARMA
TERMINATED
Dr. L. Panasci
-McG 9711-
[9238IL/0021]
A06-M25-97
A Double-Blind, Randomized, Multicenter Trial Comparing the Efficacy and Tolerability of 125 mg
and 250 mg of FASLODEX (Long-Acting ICI 182,780) with 1 mg ARIMIDEX (Anastrozole)
in Postmenopausal Women with Advanced Breast Cancer
ZENECA PHARMA
TERMINATED
Dr. L. Panasci
-McG 9712-
[FEN-INT-15]
A11-M44-97
A Study to Compare the Safety and Efficacy of DURAGESIC* (fentanyl transdermal system) with
Sustained Release Morphine (MS-CONTIN) in Patients with Cancer Pain Transferring from
Weak to Strong Opioids
JANSSEN-ORTHO
TERMINATED
Dr. M. Thirlwell
-McG 9713-
[OVA-Gy-06]
A Multicenter Phase Ilb Clinical Trial of OVAREX MAb-B43.13 for the Neo-Adjuvant
Treatment of Advanced Ovarian Cancer
ALTAREX
TERMINATED
Dr. A. Langleben
-McG 9714-
[ME96029]
A07-M28-97
Prospective, Multicenter, Uncontrolled Study to Test the Efficacy and Safety of Oral Fludarabine
Phosphate in Previously Treated Patients with B-CLL
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
BERLEX CANADA
Dr. C. Shustik
-McG 9715-
TERMINATED
[BCH-710-201/CSG-STS-1]
A09-M41-97
A Phase I/II Study of VX-710 + Doxorubicin in Patients with Metastatic and/or Locally Recurrent
Soft Tissue Sarcoma
BIOCHEM PHARMA
TERMINATED
Dr. I Hings
-McG 9716-
[Investigator Initiated]
A Phase II Trial of Chemotherapy and Hormonal Therapy in Newly Diagnosed Metastatic Prostate
Cancer
ZENECA
TERMINATED
Dr. M. Trudeau
-McG 9717-
[L1069-20]
A09-M40-97
Phase 2/3 Placebo Controlled Trial of Targretin Capsules (LGD1069) in Patients with Advanced
Non-Small Cell Lung Cancer
LIGAND
TERMINATED
Dr. W. Miller
-McG 9718-
[8468]
A10-M43-97
A Multicenter, Randomised, Phase III Study Comparing the Combination of Recombinant Human
Interferon- 1a and 5-Fluorouracil to Standard Therapy in the Treatment of Advanced Colorectal
Cancer
ARES-SERONO
TERMINATED
Dr. A. Langleben
-McG 9719-
[C03/IVB/183]
A09-M42-97
A Double-Blind, Placebo-Controlled, Minimized Phase III Study Comparing Marimastat to Placebo
as Adjuvant Therapy in Patients with Resectable Pancreatic Cancer
BRITISH BIOTECH
TERMINATED
Drs. A. Langleben and M. Wexler
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
-McG 9720-
[PSC C 301-E-00]
A Phase III Open Label, Randomized, Controlled Study in Subjects with Poor Prognosis Acute
Myelogenous Leukemia Randomized to SDZ PSC 833 + Cytarabine, Mitoxantrone and Etoposide
(AME) or AME Alone
NOVARTIS
TERMINATED
Dr. C. Shustik
-McG 9721-
[CA97003]
Phase II Study of Vincristine Sulfate Liposome Injection in Indolent (Follicular) Lymphoma
INEX PHARM
Dr. S. Caplan
COMPANY WITHDRAWN
-McG 9722-
[S014999]
An Open-Label Randomized Phase III Study of Capecitabine in Combination with Docetaxel
(Taxotere®) versus Docetaxel Monotherapy in Patients with Advanced and/or Metastatic Breast
Cancer
HOFFMANN-LaROCHE
TERMINATED
(Dr. J-P Ayoub) Dr. C. Legler
-McG 9723-
[C03/IVB/193]
A11-M64-97
A Double-Blind, Placebo-Controlled, Randomized Study Comparing Gemcitabine and Marimastat
versus Gemcitabine + Placebo as First-Line Therapy in Patients with Locally Advanced or
Metastatic Pancreatic Cancer
BRITISH BIOTECH
TERMINATED
Dr. A. Langleben
-McG 9724-
[Investigator Initiated]
Phase II Multicenter trial with Gemcitabine and Vinorelbine in Patients with Advanced (Stage IIIB
+ IV) Non-Small Cell Lung Cancer
ELI LILLY/GLAXO WELLCOME
TERMINATED
Dr. V. Hirsh
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
-McG 9725-
[RP 56976-TAX317]
A Multicenter, Randomized Phase III Study of Docetaxel (TAXOTERE®) Versus Best Supportive
Care in Patients with Non-Small Cell Lung Cancer Previously Treated with Platinum-Based
Chemotherapy
RHONE-POULENC RORER
TERMINATED
Dr. V. Hirsh
-McG 9801-
[1694IL/0022]
Pan-European Trial in Adjuvant Colon Cancer. The value of Tomudex Relative to Standard
Leucovorin-Modulated Bolus 5-FU
ZENECA
TERMINATED
Dr. M. Thirlwell
-McG 9802-
[FEM INT-01]
An Open, Randomized, Multicenter, Phase IIIb Trial Comparing 2.5 mg Femara versus 1 mg
Arimidex as Second-Line Therapy in Postmenopausal Women with Advanced Breast Cancer
Previously Treated with Anti-Estrogens
NOVARTIS
TERMINATED
Dr. S. Burdette-Radoux
-McG 9803-
[RP 56976-V-307]
A Multicenter Phase III Randomized Trial Comparing Docetaxel in Combination with Doxorubicin
and Cyclophosphamide (TAC) to 5-Fluorouracil in Combination with Doxorubicin and
Cyclophosphamide (FAC) as First-Line Chemotherapy for Metastatic Breast Cancer
RHONE-POULENC RORER
Dr. L. Panasci
TERMINATED
-McG 9803-C-
[RP 56976-V-307a]
Companion Study Evaluating the Predictive value of ErbB2 Overexpression on the Efficacy of FAC
and TAC Regimens in Metastatic Breast Cancer Patients Treated in the Protocol RP56976-V-307
RHONE-POULENC RORER
TERMINATED
Dr. L. Panasci
-McG 9804-
[208.608]
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
Efficacy and Tolerability of 2.5 mg Itasetron Intravenously and of 32 mg Ondansetron Intravenously
in the Prevention of Vomiting and Nausea in Patients Undergoing Cisplatin (> 75 mg/m2)
Containing Chemotherapy. A Randomized, Double-Blind, Multicenter, Parallel-Group Comparison
BOEHRINGER INGELHEIM/PAREXEL
TERMINATED
Dr. M. Thirlwell
-McG 9805-
[208.609]
Efficacy and Tolerability of Oral Itasetron 1 mg b.i.d. and 2.5 mg b.i.d. Compared with Oral
Ondansetron 8 mg b.i.d. Over Three Consecutive Days in the Prophylactic Treatment of Vomiting
and Nausea in Patients Undergoing Moderately Emetogenic Chemotherapy. A Randomized,
Double-Blind, Multicenter, Parallel-Group Comparison
BOEHRINGER INGELHEIM/PAREXEL
TERMINATED
Dr. M. Thirlwell
-McG 9806-
[SEQUUS-30-49]
A Phase III, Randomized, Open-Label Study of DOXIL®/CAELYX™ versus Topotecan HC1 in
Patients with Epithelial Ovarian Carcinoma Following Failure of First-Line, Platinum-Based
Chemotherapy
SEQUUS
TERMINATED
(Dr. J-P Ayoub) Dr. C. Legler
-McG 9807-
[564/020 (FUMA3008)]
A Randomized Open-Label Phase III Study of a 28-Day Oral Regimen of 5-Fluorouracil Plus
776C85 versus Intravenous 5-Fluorouracil Plus Leucovorin as First-Line Therapy in Patients with
Metastatic/Advanced Colorectal Cancer
GLAXO WELLCOME
TERMINATED
Dr. M. Thirlwell
-McG 9808[I97-042-03]
Comparison of the Effect of SCH 57050 and Anastrozole in Subjects with Breast Cancer Relapsing
After an Initial Response to Tamoxifen or Showing Progression After Tamoxifen Given as
Adjuvant to Surgery: A Prospective Double-Blind Phase III Trial (BCIRG003)
SCHERING
Dr. M. Pollak
TERMINATED
-McG 9809-
[Maxim MP-MA-0201]
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
Multicenter, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Immunotherapy
with Subcutaneous Maxamine (Histamine Dihydrochloride) Plus Proleukin (Interleukin-2) Versus
No Treatment (Standard Care) in Patients with Acute Myeloid Leukemia in First or Subsequent
Complete Remission
CROMEDICA
TERMINATED
Dr. C. Shustik
-McG 9810-
[VCC9703]
A Phase I Study of Docetaxel and Mitoxantrone Combination Chemotherapy in Patients with
Advanced Solid Tumors
Dr. S. Burdette-Radoux
WITHDRAWN
-McG 9811-
[104864-078]
An Open-Label, Multicenter Study of Single Agent Oral Topotecan Daily Times Five Every 21
Days for First-Line Treatment in Patients with Extensive SCLC Eligible for Oral Therapy.
SMITHKLINE BEECHAM
Dr. V. Hirsh
TERMINATED
-McG 9812-
[42446-03-011]
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and
Efficacy of Zoledronate (4 and 8 mg) Administered Intravenously as an Adjuvant to Anticancer
Therapy to Patients with any Cancer with Bone Metastases Other Than Breast Cancer, Multiple
Myeloma or Prostate Cancer
NOVARTIS/PAREXEL
TERMINATED
Dr. V. Hirsh
-McG 9812-E-
[42446-03-011Extension]
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and
Effects of Long-Term Treatment with Zoledronate (4 and 8 mg) when Administered Intravenously
in Addition to Anticancer Therapy to Patients with Bone Metastases Secondary to Solid Tumor
Cancers Other than Breast Cancer and Prostate Cancer - Extension Protocol
NOVARTIS/PAREXEL
Dr. V. Hirsh
TERMINATED
-McG 9813[I98-102]
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
A Phase II Trial of Chemotherapy Alone Versus Chemotherapy Plus SCH58500 in Stage III
Suboptimally Dubulked Ovarian and Primary Peritoneal Cancer Patients.
SCHERING
TERMINATED
Dr. V. Sandor
-McG 9814-
[98-012]
Phase III Comparative Study of Herceptin and Taxol with and without Carboplatin in HER2Positive Patients with Advanced Breast Cancer
American Oncology Resources (Genentech & Bristol Myers Squibb)
TERMINATED
Dr. B. Leyland-Jones
-McG 9815-
[42446-03-010]
A Randomized, Double-Blind, Multicenter, Comparative Trial of i.v. Zoledronate (4 mg or 8 mg)
versus i.v. Aredia (90 mg), as an Adjunct to Standard Therapies, in the Treatment of Multiple
Myeloma and Breast Cancer Patients with Cancer-Related Bone Lesions
NOVARTIS/PAREXEL
TERMINATED
(Dr. J.P. Ayoub) Dr. C. Legler
-McG 9815-E-
[42446-03-010]
A Randomized, Double-Blind, Multicenter, Comparative Trial of i.v. Zoledronate (4 mg or 8 mg)
versus i.v. Aredia (90 mg), as an Adjunct to Standard Therapies, in the Treatment of Multiple
Myeloma and Breast Cancer Patients with Cancer-Related Bone Lesions - Extension Protocol
NOVARTIS/PAREXEL
(Dr. J.P. Ayoub) Dr. C. Legler
TERMINATED
-McG 9816-
[I98-026-71]
A Randomized Phase II/III Trial of SCH 54031 PEG12000 Interferon alfa-2b (PEG Intron) vs.
INTRON® A in Subjects with Newly Diagnosed CML
SCHERING
TERMINATED
Dr. P. Laneuville
-McG 9901-
[MP-MA-0102]
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
Multi-Center, Randomized Open-Label Study to Evaluate the Safety and Efficacy of Combined
Immunotherapy with Subcutaneous Interleukin-2, Interferon-2b, and Maxamine™ versus
Intravenous Dacarbazine (DTIC) Alone in Patients with Advanced Malignant Melanoma
MAXIM PHARMACEUTICALS
TERMINATED
Dr. R. Rajan and Dr. S. Burdette-Radoux
-McG 9902-
[M66001]
An Open-Label Randomized Phase 3 Study Comparing Xeloda™ (Capecitabine) with i.v. bolus 5Fluorouracil in Combination with Low-Dose Leucovorin as Adjuvant Chemotherapy in Patients
who Underwent Surgery for Dukes C Colon Cancer
HOFFMANN-LA ROCHE
TERMINATED
(Dr. J.P. Ayoub) Dr. R. Rajan
-McG 9902RG-
[M6600RG]
Roche Sample Repository Research Project M66001RG for use in Conjunction with M66001 – The
X-Act Study
HOFFMANN-LA ROCHE
TERMINATED
Dr. R. Rajan
-McG 9903-
[396]
An Open-Label, Multicenter, Randomized, Phase III Comparator Study of Oral Topotecan versus
Intravenous Topotecan for Second-Line Therapy in Patients with SCLC who have Relapsed Greater
Than or Equal to 90 Days After Completion of First-Line Therapy
SMITHKLINE BEECHAM
TERMINATED
Dr. V. Hirsh
-McG 9904-
[9238IL/0025]
A Double-Blind, Randomized, Multicenter Trial Comparing the Efficacy and Tolerability of 250 mg
of FASLODEX™ (Long-Acting ICI 182,780) with 20 mg of NOLVADEX® (Tamoxifen) in
Postmenopausal Women with Advanced Breast Cancer
ZENECA LIMITED
TERMINATED
Dr. L. Panasci
-McG 9905-
[Investigator-Initiated]
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
Phase I Trial with Gemcitabine and Paclitaxel in Patients with Advanced (Stage IV only) Non-Small
Cell Lung Cancer
BRISTOL-MEYERS SQUIBB/AMGEN CANADA INC.
TERMINATED
Dr. V. Hirsh
-McG 9906-
[BCH-4556-208]
Phase II Study of Troxacitabine (BCH-4556-208) as Treatment for Patients with Metastatic
Melanoma
BIOCHEM PHARMA INC.
TERMINATED
Dr. S. Burdette-Radoux
-McG 9907-
[980226]
A Double-Blind, Randomized Study to Evaluate Single Administration Filgrastim-SD/01 versus
Daily Filgrastim as an Adjunct to Chemotherapy in Subjects with High Risk Stage II, Stage III, or
Stage IV Breast Cancer
AMGEN INC.
TERMINATED
Dr. W. Miller
-McG 9908-
[RSR13 RT-010]
A Phase II Study of Induction Chemotherapy with Paclitaxel and Carboplatin Followed by
Radiation Therapy with RSR13 for Locally Advanced Inoperable Non-Small Cell Lung Cancer
ALLOS THERAPEUTICS, INC.
Dr. Luis Souhami
TERMINATED
-McG 9909-
[IN5-98-12-007]
A Phase III Randomized Study of SC-70935 vs. G-CSF in Mobilization of Peripheral Blood Stem
Cells When Used with Cyclophosphamide and Etoposide in Patients with Lymphoma
SEARLE CANADA
Dr. Pierre Laneuville
TERMINATED
-McG 9910-
[104864-A/201]
A Phase III, Open-Label, Multicenter, Randomized, Comparative Study of Topotecan, Ara-C and GCSF (TAG) versus Idarubicin, Ara-C and G-CSF (IDAG) in MDS Patients with RAEB (High-Risk),
RAEB-t or in Patients with AML from a Preceding Phase of MDS
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
SMITHKLINE BEECHAM
Dr. Chaim Shustik
-McG 9911-
TERMINATED
[990117]
A Randomized, Multicenter, Open-Label Phase II Study of Filgrastim-SD/01 versus Daily
Filgrastim following ESHAP Chemotherapy for Non-Hodgkin’s Lymphoma
AMGEN INC.
TERMINATED
Dr. W. Miller
-McG 9912-
[NESP-980291]
A Randomised, Double-Blind, Placebo-Controlled, Dose-Finding Study of Novel Erythropoiesis
Stimulating Protein (NESP) Administered Once Every Three Weeks by Subcutaneous (SC)
Injectino for the Treatment of Anaemia in Subjects with Solid Tumours Receiving Multicycle
Chemotherapy
AMGEN INC.
TERMINATED
Dr. Jaroslav Prchal
-McG 9913-
[VINA2004]
A Phase II, Open-Label, Prospective, Randomized, Controlled, Multicenter Study of Single Agent
NAVELBINE® (vinorelbine tartrate) Administered Orally at the Dose of 60mg/m² with Possible
Escalation to 70mg/m² or Administered Intravenously at the Dose of 30mg/m² for the Treatment of
Chemotherapy-Naïve Subjects with Inoperable, Stage IIIb or IV Non-Small Cell Lung Cancer
(NSCLC)
GLAXO WELLCOME
TERMINATED
Dr. Vera Hirsh
-McG 9914-
[B015899 / RO 45-2317]
An Open-Label Randomized Controlled Phase 2 Study of Herceptin (trastuzumab) in Combination
with Chemotherapy in Patients with HER-2 Over-Expression/Amplification in Advanced and/or
Metastatic Non-Small-Cell Lung Cancer (NSCLC)
HOFFMANN-LA ROCHE LIMITED
TERMINATED
Dr. Vera Hirsh
-McG 9915-
[B9E-CA-JHQR]
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
Phase 2 Trial of Gemcitabine and Carboplatin in Patients with Locally Advanced or Metastatic
Urothelium Cancer
ELI LILLY
TERMINATED
Dr. M. Trudeau
-McG 9916Phase I Trial of First Line Chemotherapy with Cisplatin, VP-16 and Fludarabine in Patients with
Extensive Small Cell Lung Cancer
BERLEX CANADA INC.
NEVER ACTIVATED
Dr. V. Hirsh
-McG 9917-
[UFT/MEN.04 (Theradex #B99-1320)]
A Phase II Trial of ORZEL™ (UFT® + Leucovorin) Given as a Twice-Daily Regimen in the
Treatment of Patients with Metastatic Colorectal Cancer
BRISTOL-MEYERS SQUIBB.
TERMINATED
Dr. A. Langleben
-McG 9918-
[5416.031]
A Randomized, Open-Label, Multicenter Phase III Study of 5-FU/Leucovorin With or Without
Concomitant SU5416 in Patients With Metastatic Colorectal Cancer
Sugen
TERMINATED
(Dr. J.P. Ayoub) Dr. R. Rajan
-McG 9919[RFS2000-02]
Phase III Randomized Study of RFS 2000 (9-Nitro-camptothecin, 9-NC) Versus Gemcitabine HCI
in Chemonäive Pancreatic Cancer Patients
Supergen
TERMINATED
(Dr. J.P. Ayoub) DrM. Thirlwell
-McG 9919ext-
[RFS2000-02ext]
Phase III: An Open-Label Study of RFS-2000 (9-Nitro-camptothecin, 9-NC) in Pancreatic Cancer
Patients Who Have Disease Progression While Receiving Gemcitabine HCI Treatment in the RFS
2000-02 Study
Supergen
TERMINATED
Dr. M. Thirlwell
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
-McG 9920-
[RFS2000-06]
Phase III Randomized Study of RFS 2000 (9-Nirto-camptothecin, 9-NC) Versus 5-Fluorouracil (5FU) in Pancreatic Cancer Patients that have Progressive Disease Following Gemcitabine HCI
Treatment
Supergen
TERMINATED
(Dr. J.P. Ayoub) Dr. M. Thirlwell
-McG 9921-
[RFS2000-09]
Phase III Study of RFS 2000 (9-Nitro-camptothecin, 9-NC) Versus Most Appropriate
Chemotherapy in Refractory Cancer Patients
Supergen
TERMINATED
Dr. J.P. Ayoub
-McG 9922-
[IMP20784]
An Open-Label, Multicentre, Randomised, Phase III Study Comparing the Combination of
Recombinant Human IFN-beta-1a and Radiotherapy to Radiotherapy Alone in the Treatment of
Patients with Inoperable, Locally Advanced NSCLC After Neoadjuvant Platin-Based Chemotherapy
Ares Sorono
WITHDRAWN
Dr. A. Langleben
-McG 9923-
[OVA-302]
A Study of the Safety and the Efficacy of MAK Cells Mixed With Humanized Anti-HER2/neu
Bispecific Monoclonal Antibodies as Consolidation of First or Second Line Chemotherapy in
Patients With Epithelial Ovarian Cancer
IDM
NEVER ACTIVATED
Dr. G. Batist
-McG 9924-
[104864-410]
A Randomised Open-Label Multicentre Phase II Study to Evaluate the Safety and Efficacy of
Intravenous Topotecan Given With Either Cisplatin or Etoposide Every 21 Days as First-Line
Therapy in Patients With Extensive-Disease Small Cell Lung Cancer
SmithKline Beecham
TERMINATED
Dr. V. Hirsh
-McG 9925-
[PRI/EPO-CAN-17]
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
A Randomized Study to Evaluate the Effect of Maintaining Hemoglobin Levels with EPREX™
(epoetin alfa) on Anemia and Quality of Life in Breast Cancer Patients Receiving Myelotoxic
Chemotherapy
Janssen-Ortho
WITHDRAWN
Dr. A. Langleben
-McG 9926-
[U2035g]
A Phase III, Randomized, Open-Label Trial of CHOP Chemotherapy Plus Rituxan (IDEC-C2B8)
versus CHOP Chemotherapy Alone for Previously Untreated, Clinically Aggressive (IPI2)
Intermediate/High-Grade CD20 Non-Hodgkin’s Lymphoma
Genentech
TERMINATED
Dr. C. Shustik
-McG 0001-
[CZOL446 0702]
A Randomized, Placebo-Controlled Study on the Efficacy and Tolerability of Zometa in the
Prevention of Disease Recurrence in Patients with Node Positive Primary Breast Cancer
Novartis
WITHDRAWN
BY
COMPANY
Dr. L. Panasci
-McG 0002-
[CA99002]
Pivotal Phase II Multicenter Study of Vincristine Sulfate Liposomes Injection in Diffuse Large BCell Non-Hodgkin’s Lymphoma at Second or Later Relapse
Inex
TERMINATED
Dr. S. Caplan
-McG 0003-
[195-301]
Phase III, Randomized, Multicenter Study to Assess the Efficacy and Safety of HuM195
(Recombinant Humanized Anti-CD33 Monoclonal Antibody) in Combination with Standardized
Chemotherapy Compared to Standardized Chemotherapy Alone in the Treatment of Patients With
Refractory or First-Relapsed Acute Myelogenous Leukemia (AML)
Theradex
COMPANY WITHDRAWN
Dr. P. Laneuville
-McG 0004[R115777-INT-11]
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
A Phase III Double-Blind, Placebo Controlled Trial of Gemcitabine Plus Placebo vs. Gemcitabine
Plus R115777 in Chemonaive Patients with Advanced Pancreatic Cancer
Janssen-Ortho
Dr. A. Langleben/Beverly DeSalis
TERMINATED
-McG 0005-
[T99-0046]
Multicenter, Open-Ended, Double-Blind, Placebo-Controlled, Phase III Study of AE-941 in
Addition to Combined Modality Treatment (Chemotherapy/Radiotherapy) For Locally Advanced
Unresectable Non-Small Cell Lung Cancer
Aeterna
TERMINATED
Dr. G.Batist/Ginette Ricard
-McG 0006-
[PR96-27-031]
The Effects of PROCRIT (Epoetin alfa) on Hemoglobin, Symptom Distress and Quality of Life
During Chemotherapy in Lymphoma, Chronic Lymphocytic Leukemia or Multiple Myeloma
Patients with Mild to Moderate Anemia
Ortho Biotech
WITHDRAWN
Dr. C. Shustik
-McG 0007-
[M39021]
An Open-Label, Randomized, Multi-Center, Phase III Trial Comparing CVP + MabThera to
Standard CVP Chemotherapy in Patients with Previously Untreated CD20 Positive Follicular
Lymphoma (Stage III-IV)
Hoffman-LaRoche
CLOSED
Dr. C. Shustik
-McG 0008-
[RSR13 RT-009]
A Phase 3 Randomized, Open-Label, Comparative Study of Standard Whole Brain Radiation
Therapy with or without RSR13 in Patients with Brain Metastases
Allos Therapeutics
TERMINATED
Dr. K. Sultanem
-McG 0009-
[104864/552]
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
A Phase II, Multicenter, Open-Label Study of Oral Topotecan and Cisplatin in Ovarian Cancer
Recurring  6 Months Following Initial Platinum-Based Chemotherapy
SmithKline Beecham
TERMINATED
(Dr. M. Trudeau) (Dr. A. Langleben) Dr. G. Stanimir
-McG 0010-
[98-6475-183]
A Randomized, Open-Label, Multicenter, Phase III Study Study Comparing the Efficacy and Safety
of Gemcitabine and Irenotecan HCI (CPT-11) to the Gemcitabine Alone in Patients with Locally
Advanced or Metastatic Pancreatic Cancer who Have Not Received Prior Systemic Therapy
Pharmacia
TERMINATED
(Dr. Trudeau) (Dr. A. Langleben) Dr. W. Miller
-McG 0011-
[CSTI571 0106] “IRIS”
A Phase III Study of STI571 Versus Interferon-a (IFN-a) Combined with Cytarabine (ARA-C) in
Patients with Newly Diagnosed Previously Untreated Philadelphia Chromosome Positive (PH+)
Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
Novartis
CLOSED
Dr. C. Shustik
-McG 0011E- [STI571 0106 Extension]
An Extension Protocol for Patients who Progress to Accelerated Phase or Blast Crisis on the INF-a
+ Ara-C Treatment Arm of the Core Protocol
Novartis
CLOSED
Dr. C. Shustik
-McG 0012-
[H4Z-MC-JWXD]
Phase 3 Randomized Double-Blind Evaluation of LY353381 Compared with Tamoxifen in Women
with Locally Advanced or Metastatic Breast Cancer
Eli Lilly
TERMINATED
Dr. L.Panasci
-McG 0013-
[N91-00-02-040]
A Randomized, Double-Blind, Placebo Controlled Comparison of the Analgesic Activity of
Valdecoxib (SC-65872) 40mg BID as Add-on Therapy to Opioid Medication in Patients with
Chronic Cancer Pain
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
Searle
Dr. B. Gagnon
-McG 0014-
TERMINATED
[-]
Phase II Multicenter Trial with Gemcitabine and Docetaxel in Patients with Advanced (Stage IIIB +
IV) Non-Small Cell Lung Cancer
Aventis Pharma
TERMINATED
Dr. V. Hirsh
-McG 0015-
[1164.4]
A Phase III, Double-Blind, Randomized, Placebo-Controlled Study of Porfiromycin Used as an
Adjuvant to Radiation Therapy in Postoperative Head and Neck Cancer Patients
Boehringer Ingelheim
WITHDRAWN
-McG 0016-
[9902]
A Phase III Multicenter, Randomized, Open-Label Trial Evaluating High Dose Melphalan plus
Holmium-166-DOTMP versus High Dose Melphalan Alone when Given in Conjunction with
Peripheral Blood Stem Cell Transplantation in Patients with Multiple Myeloma
NeoRx Corporation
Dr. C. Shustik
INVESTIGATOR
WITHDRAWN
-McG 0017-
[1839IL/0017]
A Randomized, Double-Blind, Phase III Comparative Trial of 2 Doses of ZD1839 (IRESSA™) in
Combination with Paclitaxel and Carboplatiin versus Placebo in Combination with Paclitaxel and
Carboplatin in Chemotherapy-Naïve Pateints with Advanced (Stage III or IV) Non-Small Cell Lung
Cancer
AstraZeneca
TERMINATED
Dr. V. Hirsh
-McG 0018-
[WO16229]
A Phase II Study of Herceptin Monotherapy Administered 3 Weekly in Women with HER2
Overexpression/Amplification in Metastatic Beast Cancer
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
Hoffmann La-Roche
Dr. L. Panasci
-McG 0019-
TERMINATED
[MEL06199]
A Phase I Study of Heterologous Prime-Boost Immunization by Intranodal or Subcutaneous
Administration with Recombinant Canarypox Virus Expressing Tumour Antigen gp100 (Modified)
Followed by Modified gp100 Peptide Combination in Melanoma
Aventis Pasteur Mérieux Connaught
TERMINATED
Dr. S. Burdette-Radoux
-McG 0020-
[GN301]
Randomized Study of Dacarbazine Versus Dacarbazine Plus G3139 (Bcl-2 Antisense
Oligonucleotide) in Patients with Advanced Malignant Melanoma
Genta Incorporated
TERMINATED
Dr. W. Miller
-McG 0020ext-
[GM214]
Continuation Protocol for Genasense (G3139, Bcl-2 Antisense Oligonucleotide) and Dacarbazine in
Patients with Malignant Melanoma Who to Responded to this Combination in GM301
Genta Incorporated
TERMINATED
Dr. W. Miller
-McG 0021[PRI/EPO-INT-76/EPO-CA-489]
A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Impact of Maintaining
Hemoglobin Using EPREX® (Epoetin Alpha; RWJPRI-22512) in Metastatic Breast Carcinoma
Subjects Receiving Chemotherapy
Janssen-Ortho
TERMINATED
Dr. M. Thirlwell
-McG 0022-
[EPO CAN 20]
Randomized Trial of Epoetin Alpha in Patients with Advanced Non-Small Cell Carcinoma of the
Lung
OCOG
TERMINATED
Dr. B. Gagnon/Mary Ann Tasca
-McG 0023-
[VIN20009]
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
A Phase II Multi-Centre Trial of Sequential Therapy with Vinorelbine and Gemcitabine in Patients
with Stage IIIB + IV Non-Small Cell Lung Cancer (NSCLC) with Emphasis on the Elderly and Frail
Glaxo Wellcome
CLOSED
Dr. Vera Hirsh
-McG 0024-
[20010116]
A Phase 3 Clinical Trial of Immunotherapy with Humanized LL2 IgG (AMG 412) in Subjects with
Low-Grade, Follicular, B-cell Non-Hodgkin’s Lymphoma Refractory to Rituxan® (rituximab)
Amgen
TERMINATED
Dr. C. Shustik
-McG 0101-
[CSTI571 0113]
An Expanded Access Protocol of STI571 in Patients with Chronic Myeloid Leukemia Who Are
Hematologically or Cytogenetically Resistant or Refractory to Interferon-Alpha, or Intolerant of,
Interferon-Alpha
Novartis
TERMINATED
Dr. C. Shustik
-McG 0102-
[CSTI571 0114]
An Expanded Access Protocol of STI571 in Adult Patients with Either Chronic Myeloid Leukemia
in Accelerated Phase or Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
Novartis
TERMINATED
-McG 0103-
[CSTI571 0115]
An Open-Label, Multicenter Expanded Access Study of STI571 in Patients with Either Chronic
Myeloid Leukemia in Myeloid or Lymphoid Blast Crisis, or Philadelphia Chromosome-Positive
Acute Myelogenous Leukemia
Novartis
TERMINATED
Dr. C. Shustik
-McG 0104-
[BCH-4556-214]
A Phase II Study of Troxatyl in Patients with CML Blastic Phase Disease
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
BioChem Pharma, Inc.
Dr. P. Laneuville
-McG 0105-
COMPANY WITHDRAWN
[Æ-MM-00-02]
Neovastat (Æ-941) in Refractory and Early Relapse Multiple Myeloma Patients
Æterna Laboratories, Inc.
Dr. C. Shustik
-McG 0106-
TERMINATED
[H3E-MC-JMEI(a)]
A Phase 3 Trial of ALIMTA vs Docetaxel in Patients with Locally Advanced or Metastatic NonSmall Cell Lung Cancer (NSCLC) Who Were Previously Treated with Chemotherapy
Eli Lilly
Dr. V. Hirsh/Sylvie Beaudoin
TERMINATED
-McG 0107-
[104864/557]
A Phase II Trial of Topotecan and Cisplatin in Patients with Metastatic or Recurrent Squamous Cell
Carcinoma of the Cervix
SmithKline Beecham
TERMINATED
(Dr. M. Trudeau) (Dr. A. Langleben) Dr. L. Souhami
-McG 0108-
[CA163-013]
A Phase II Study of Epothilone Analog BMS-247550 in Patients with Metastatic Gastric
Adenocarcinoma Previously Treated with a Fluoropyrimidine and/or a Platinum
Bristol-Myers Squibb
TERMINATED
Dr. A. Langleben
-McG 0108-BC
[CA163-022]
A Protocol to Collect Blood Samples for Pharmacogenomic Research from Patients Enrolled in a
Clinical Trial of BMS-247550 Epothilone B Analog.
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
Bristol-Myers Squibb
Dr. A. Langleben
-McG 0108-TC
WITHDRAWN BY COMPANY
[CA163-016]
A Protocol to Collect a Tumour Tissue Sample for Pharmacogenomic Research from Patients
Enrolled in a Clinical Trial of BMS-247550 Epothilone B Analog.
Bristol-Myers Squibb
WITHDRAWN BY COMPANY
Dr. A. Langleben
-McG 0109-
[401.00.001]
An Open Label, Randomized, Controlled, Phase III, Multi-center, Clinical Trial of PN401 with
High Dose 5-Fluorouracil (5FU) versus Gemcitabine for Treatment of Patients with Advanced
Pancreatic Cancer
Pro-Neuron, Inc.
TERMINATED
Dr. W. Miller
-McG 0110-
[B9E-CA-0312]
Phase I/II Multicenter Trial with Carboplatin and Gemcitabine Induction Chemotherapy, Followed
by Radiotherapy Concomitantly with Low-Dose Weekly Paclitaxel and Gemcitabine for Patients
with Stage IIIA + B Non-Small Cell Lung Cancer
Eli Lilly
CLOSED
Dr. V. Hirsh & Dr. M. Duclos
-McG 0111-
[TH9402/II/NHL/002]
Autologous TH9402 Purged Progenitor Cell transplantation for Non-Hodgkin’s Lymphoma
Theratechnologies Inc.
Dr. P. Laneuville
TERMINATED
-McG 0112-
[EPO-CAN-15]
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Impact of Maintaining
Haemoglobin Levels Using EPREX*/PROCRIT® (Epoetin alfa) in Limited Disease Small Cell
Lung Cancer (LD SCLC) Subjects Receiving Combined Chemotherapy and Radiation Therapy.
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
Ortho Biotech Inc.
Dr. V. Hirsh
-McG 0113-
TERMINATED
[GMY302]
Randomized Phase III Study of Dexamethasone With or Without Genasense™ 9Bcl-2 Antisense
Oligonucleotide) in Patients with Relapsed or Refractory Multiple Myeloma
Genta
TERMINATED
Dr. C. Shustik
-McG 0114-
[RPI0003]
A Phase II, Open-Label, Multi-Center Trial of Angiozyme in Combination with 5-FU, Leucovorin
and Irinotecan in Subjects with Metastatic Colorectal Cancer
Ribozyme Pharmaceuticals
TERMINATED
Dr. W. Miller
-McG 0114ext-
[RPI0102]
A Phase II, Open-Label, Multicenter Trial of Angiozyme in Subjects With Metastatic Colorectal
Cancer Who Have Completed RPI0003
Ribozyme Pharmaceuticals
TERMINATED
Dr. W. Miller
-McG 0115-
[EFC4585]
A Multicenter, Open-label, Randomized, Two-Arm Study of Irinotecan (CPT-11) Versus the
Combination of Oxaliplatin + Irinotecan (CPT-11) as Second-Line Treatment of Metastatic
Colorectal Carcinoma
Sanofi-Synthelabo
TERMINATED
Dr. W. Miller
-McG 0116-
[88951A-PRT031
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
A Randomized, Open-Label, Multicenter Phase III Study Comparing the Efficacy and Safety of a
Combination of Intravenous DX-8951f (Exatecan Mesylate) Plus Gemcitabine to Gemcitabine
Alone in Patients with Locally Advanced or Metastatic Cancer of the Exocrine Pancreas Who Have
Not Received Prior Chemotherapy
Daiichi
TERMINATED
Dr. M. Thirlwell
-McG 0117[R115777-INT-17]
A Phase 2 Study Evaluating the Efficacy of the Farnesyl Transferase Inhibitor (FTI) R115777 in
Patients with Refractory or Elapsed Acute Myeloid Leukemia (AML)
Janssen Research Fdn.
TERMINATED
Dr. C. Shustik
-McG 0118-
[COL14]
Pilot Phase II Study of Safety and Immunogenicity of an Alvac-CEA/B7.1 Vaccine Administered
Either Subcutaneously or Intranodally, Concurrently with Chemotherapy, in Patients with Metastatic
Colorectal Adenocarcinoma.
Aventis
WITHDRAWN BY COMPANY
Dr. A. Langleben
-McG 0119-
[EFC 4584]
A Multicenter, Open-Label, Randomized, Three-Arm Study of 4-Fluorouracil (5-FU) Plus
Leucovorin (LV) or Oxaliplatin or a Combination or 5-FU/LV + Oxaliplatin as Second-Line
Treatment of Metastatic Colorectal Carcinoma.
Sanofi
TERMINATED
Dr. W. Miller
-McG 0120-
[440E-ONC-0020-262]
A Randomized, Phase III Trial Comparing CPT-11 (Irinotecan HCI; Camptosar Injection) Cisplatin
with Etoposide in Patients with Previously Untreated, Extensive, Small-Cell Lung Cancer
Pharmacia
TERMINATED
Dr. V. Hirsh
-McG 0121-
[EPO906A2203]
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
An Open-Label Phase IIA Trial Evaluating the Safety and Efficacy of EPO906 in Patients with
Advanced Ovarian, Primary Fallopian, or Primary Peritoneal Cancer
Novartis
WITHDRAWN
Dr. M. Trudeau
-McG 0122-
[PO2565]
A Phase II, Open-Label Study of Interferon alfa-2b in Combination with SCH 66336 in Patients
with Metastatic Renal Cell Cancer
Schering
TERMINATED
Dr. S. Tanguay
-McG 0123[TNP-470]
A Phase II Study Comparing TNP-470/Paclitaxel/Carboplatin Combinations to
Paclitaxel/Carboplatin Alone for Treatment of Non-Small Cell Lung Cancer
TAP Pharmaceuticals
Dr. A. Langleben
WITHDRAWN BY COMPANY
-McG 0124-
[BO16411]
A Randomised, Double-Blind, Placebo Controlled, Multicentre, Phase III Study of Tarceva Plus
Chemotherapy (Cisplatin and Gemcitabine) Versus Chemotherapy Alone in Patients with Advanced
(Stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC) Who Have Not Received Prior
Chemotherapy
Hoffmann-La Roche
TERMINATED
Dr. V. Hirsh
-McG 0124 RGRoche Sample Repository Research Project in Conjunction with Hoffman-LaRoche Protocol
Entitled: “A Randomised, Double-Blind, Placebo Controlled, Multicentre, Phase III Study of
Tarceva Plus Chemotherapy (Cisplatin and Gemcitabine) Versus Chemotherapy Alone in Patients
with Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC) Who Have Not Received
Prior Chemotherapy”
Hoffmann-La Roche
TERMINATED
Dr. V. Hirsh
-McG 0125-
[0473IL/0016]
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
A Multicentre, Open-Label, Randomized, Parallel-Group Study Evaluating the Efficacy and
Tolerability of ZD0473 Versus Doxorubicin HCl liposome injection (Doxil™, Caelyx™) in Patients
with Refractory Advanced Epithelial Ovarian Cancer in Whom Both Platinum- and PaclitaxelBased Chemotherapy Regimens Have Failed
AstraZeneca
WITHDRAWN BY COMPANY
Dr. M. Trudeau
-McG 0126-
[5416.035]
A Phase III, Randomized, Open-Label, Multicenter, International Study Comparing the
Combination
of
SU5416/Irinotecan/5-Fluorouracil/Leucovorin
versus
Irinotecan/5Fluorouracil/Leucovorin Alone as First-Line Therapy of Patients With Previously Untreated
Metastatic Colorectal Cancer
Sugen/Pharmacia
WITHDRAWN BY COMPANY
Dr. A. Langleben
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
-McG 0127-
[971-ONC-0028-057]
A Pilot, Open-Label, Randomized, Comparative Study of Exemestane Versus Anastrozole in PostMenopausal Breast Cancer Patients With Visceral Disease
Pharmacia
TERMINATED
Dr. M. Thirlwell
-McG 0128-
[P01848]
Phase II Multi-Centre Trial of Caelyx™ in Combination with Herceptin® in Her-2 Over-expressing
Advanced Breast Cancer
Schering
TERMINATED
Dr. L. Panasci
-McG 0129-
[PC4]
A Prospective, Randomised, Controlled, Double-Blind, Multinational, Multi-Centre Study of
G17DT Immunogen in Combination With Gemcitabine in Previously Untreated Subjects With
Locally Advanced (Nonresectable Stage II and III), Recurrent Disease Following Primary Resection,
or Metastatic (Stage IV) Adenocarcinoa of the Pancreas
Orion
TERMINATED
Dr. W.Miller
-McG 0130-
-See McG 0202
[MP-8899-0104]
A Phase III Multi-Centre Controlled Trial with Stratified Randomization Comparing the Efficacy of
Interleukin-2 (IL-2) plus Histamine Dihydrochloride (HDC) versus IL-2 Alone to Increase the
Duration of Survival in Patients with AJCC Stage IV Malignant Melanoma with Hepatic Metastases
Maxim Pharmaceuticals, Inc.
WITHDRAWN
Dr. S. Burdette-Radoux
-McG 0131-
[Biomed 777-CLP-29]
Phase III Study of Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer
BioMedicines, Inc.
TERMINATED
Dr. W. Miller
-McG 0201-
[RSR13 RT-012]
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
A Phase I/II Study to Evaluate the Safety, Tolerance, and Efficacy of RSR13 Administered to
Patients Receiving a Course of Cisplatin and Radiation Therapy for Locally Advanced Carcinoma
of the Cervix
Allos Therapeutics, Inc.
TERMINATED
Dr. L. Souhami/Sylvia Papazian
-McG 0202-
[MP-8899-0104]
A Phase III, Multi-center Controlled Trial with Stratified Randomization Comparing the Efficacy of
Interleukin-2 (IL-2) plus Histamine Dihydrochloride (HDC) versus Il-2 Alone to Increase the
Duration of Survival in Patients with AJCC Stage IV Malignant Melanoma with Hepatic Metastasis
Maxim Pharmaceuticals, Inc.
COMPANY WITHDRAWN
Dr. S. Burdette-Radoux
-McG 0203-
[ZX101-301]
A Phase III Randomized Controlled Study Comparing the Survival of Patients with Unresectable
Hepatocellular Carcinoma (HCC) Treated with THYMITAQ to Patients Treated with Doxorubicin
Zarix, Inc.
WITHDRAWN
Dr. A. Langleben
-McG 0204-
[GL303]
Randomized Study of Fludarabine and Cyclophosphamide with or without Genasense™ (Bcl-2
Antisense Oligonucleotide) in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia
Genta Incorporated
TERMINATED
Dr. C. Shustik
-McG 0205-
[104864A/387]
An Open-Label, Multicentre, Randomised, Phase III Study Comparing Oral Topotecan to
Intravenous Docetaxel in Patients With Pretreated Advanced (Stage IIIB/IV) Non-Small Cell Lung
Cancer
GlaxoSmithKline
TERMINATED
Dr. V. Hirsh
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
BL
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McG Studies
-McG 0206-
[LOR/VIR/P03/002]
A Phase III, Double-Blind, Multicenter, Randomized Study in Chemonaive Patients with Locally
Advanced or Metastatic Pancreatic Cancer to Compare a Combination Therapy of Virulizin® plus
Gemcitabine versus Placebo plus Gemcitabine; Optional Second-Line Therapy may Include
Continuation of Virulizin® or Placebo, Alone or in Combination with 5-Fluorouracil
Lorus Therapeutics Inc.
TERMINATED
Dr. M. Thirlwell
-McG 0207[GIOV-001]
Actimmune® (Interferon gamma-1b) in Combination With Chemotherapy (Carboplatin/Paclitaxel)
for First-line Therapy of Advanced Ovarian or Primary Peritoneal Carcinoma
Intermune
TERMINATED
Dr. W. Miller/Ginette
-McG 0208[P02143]
A Phase II Study of Temozolomide (SCH 52365) in Subjects with Brain Metastasis from Non-Small
Cell Lung Cancer
Schering Canada Inc.
WITHDRAWN
BY
COMPANY
Dr. L. Souhami
-McG 0209-
[CA012-0]
A Controlled Randomized, Phase III, Multicenter, Open-Label Study of ABI-007 (A Cremophor
Free, Protein Stabilized, Nanoparticle Paclitaxel) and Taxol in Patients with Metastatic Breast
Cancer
American Bioscience.
TERMINATED
Dr. L. Panasci
-McG 0210-
[TNT 0101]
A Phase III, Open Label, Randomized Comparative Study of Interstitial 131I-chTNT-1/B
(Cotara)Versus Temozolomide for the Treatment of Recurrent Glioblastoma Multiforme (GBM).
Peregrine.
Dr. L. Souhami
TERMINATED
-McG 0211-
[]
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
A Phase II Study of Using IMRT Radiation for Patients with Unresectable Recto Sigmoid Cancer.
Dr. T. Vuong
CLOSED
-McG 0212-
[EFC4690]
Phase III Randomized Trial of Concomitant Radiation, Cisplatin and Tirapazamine (SR259075)
Versus Concomitant Radiation and Cisplatin in Patients with Advanced Head and Neck Cancer
Sanofi Synthelalo/PPD Development
Dr. G. Shenouda/ Ginette Ricard
TERMINATED
-McG 0212ext-
[EFC 5512]
IRB#: A00-M47-05B
Phase III Randomized Trial of Concomitant Radiation, Cisplatin, and Tirapazamine (SR259075)
versus Concomitant Radiation and Cisplatin in Patients with Advanced Head and Neck Cancer.
Sanofi Aventis
Dr. G. Shenouda
CLOSED
-McG 0213-
[CA163-036-039]
A Phase II Study of Novel Epothilone BMS-247550 in Patients with Progressive Small Cell Lung
Cancer Which Was Sensitive to First-Line Chemotherapy
Bristol Myers-Squibb
Dr. V. Hirsh
TERMINATED
-McG 0214-
[]
Pegfilgrastim (SD.01) versus Filgrastim (Neupogen) in Cancer Patients. A Randomized Cross-Over
Trial to Evaluate Patient Preference and Resource Utilization
Amgen
Dr. W. Miller
TERMINATED
-McG 0215-
[]
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
A Phase III Multi-Center, Randomized, Open-Label Study to Compare Survival and to Evaluate the
Efficacy and Safety of Best Supportive Care Plus Bay 59-8862 Versus Best Supportive Care Only in
Patients with Metastatic Non-Small Cell Lung Cancer (NSClC with Brain Metastases).
Bayer
Dr. W. Miller
TERMINATED
-McG 0216-
[GN304]
Randomized Study of Docetaxel Versus Docetaxel Plus Genasense (G3139 BCL-2 Antisense
Oligonucleotide) in Patients with Previously Treated Non-Small Cell Lung Cancer.
Genta
Dr. W. Miller
TERMINATED
-McG 0217[M34101-039]
An International, Multicenter, Randomized, Open-Label Study of PS-341 Versus High-Dose
Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma
Millennium Pharmaceuticals/PRA International
Dr. C. Shustik
TERMINATED
-McG 0217ext-
[M34101-040]
An International, Non-Comparative, Open-Label Study of PS-341 Administered to Patients with
Multiple Myeloma Who Experienced Relapsed or Progressive Disease After Receiving at Least
Four Previous Treatment Regimens or Experienced Progressive Disease After Dexamethasone in
Millennium Protocol M34101-039
Millennium Pharmaceuticals/PRA International
Dr. C. Shustik
TERMINATED
-McG 0218-
[2000-03]
A Phase 3 Trial to Evaluate the Safety and Efficacy of Specific Immunotherapy, Recombinant
Idiotype Conjugated to KLH and GM-CSF, Compared to Non-Specific Immunotherapy, KLH with
GM-CSF, in Patients with Follicular Non-Hodgkin’s Lymphoma
Genitope Corporation
Dr. C. Shustik
TERMINATED
-McG 0219-
[SGI-DAC-012]
A Phase II, Multicenter Study of Decitabine (5 – AZA-2 Deoxyxytidine) in Chronic Myelogenous
Leukemia Blast Phase Refractory to Imaginib Mesylate.
SuperGen
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
Dr. Shustik
-McG 0220-
WITHDRAWN
[W01-370]
Phase IV, Double-Blind, Randomized, Comparator Study to Assess the Benefits of an Experimental
Product With a Novel Oil Blend Versus a Standard Nutritional Product in Subjects with Stage IV
Non-Small Cell Lung Cancer.
Abbott Laboratories
WITHDRAWN BY COMPANY
Dr.N.MacDonald
-McG 0221-
[304820]
Efficacy and Safety of Subsequent Treatment with 90Y – ibritumomab Tiuxetan Versus no Further
Treatment in Patients with Stage III or IV Follicular non-Hodgkin’s Lymphoma Having Achieved
Partial or Complete Remission After First Line Chemotherapy. A Prospective, Multicenter,
Randomized Phase III Clinical Trial.
Berlex Canada Inc.
Dr. Shustik
TERMINATED
-McG 0222-
[L1069-48]
Randomized Phase III Trial Comparing Targretin Capsules/Carboplatin/Paclitaxel Versus
Carboplatin/Paclitaxel in Chemotherapy Naïve Patients with Advanced or Metastatic Non-Small
Cell Lung Cancer.
Ligand
Dr. W.Miller
TERMINATED
-McG 0223-
[PCYC - 0211]
Randomized Phase III Trial of Xcytrin (Motexafin Gadolinium) Injection for the Treatment of Brain
Metastases in Patients with Non-Small Cell Lung Cancer Undergoing Whole Brain Radiation
Therapy.
Pharmacyclics
Dr. Souhami
TERMINATED
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
-McG 0224-
[10653]
An Uncontrolled, Phase II Study Evaluating Anti-Tumor Efficacy and Safety of BAY 59-8862 in
Patients with Taxane Resistant Non-Small Cell Lung Carcinoma (NCSLC).
Bayer
Dr. Wilson Miller
TERMINATED
-McG 0225-
[20010145]
A Randomized, Double-Blind, Placebo-Controlled Study of Subjects with Previously Untreated
Extensive-Stage Small Cell Lung Cancer (SCLC) Treated with Platinum plus Etoposide
Chemotherapy with or without Darbepoetin Alfa.
Amgen
Dr.V.Hirsh
TERMINATED
-McG 0226-
[PGT304]
CT-2103 vs Gemcitabine or Vinorelbine for the Treatment of PS = 2 Patients with Chemotherapy
Naïve Advance Non-Small Cell Lung Cancer (NSCLC): A Phase III Study.
Cell Therapeutics
Dr. V. Hirsh/Clara Dunn
TERMINATED
-McG 0227-
[RT 013]
A Phase III Randomized, Open-Label Comparative Study of Induction Chemotherapy, Followed by
Thoracic Radiation Therapy with Supplemental Oxygen, with or without Concurrent RSR13
(efaproxiral), in Patients With Locally Advanced Unresectable (Stage IIIA/IIIB) Non-Small Cell
Lung Cancer.
Allos
Dr. Luis Souhami
TERMINATED
-McG 0228-
[P02948]
Phase II Trial of CAELYX® and Cyclophosphamide in Metastatic Breast Cancer.
Schering
Dr. L. Panasci
TERMINATED
-McG 0229-
[XRP6258A (RPR 116258A)/2001]
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
A Multicenter Phase II Randomized Study Comparing RPR 11625A Administered as a 1HourIntravenous Infusion Either Weekly (D1, D8, D15, D22 Every Five Weeks) or Every Three
Weeks Versus RPR 109881A Administered as a 1-Hour Intreavenous Infusion Every Three Weeks
in Taxoid Resistant Metastatic Breast Cancer Patients
Aventis
Dr. L. Panasci
WITHDRAWN
-McG 0230-
[COL13]
Pilot Phase II Study of Safety and Immunogenicity of an ALVAC –CEA/B7.1 Vaccine
Administered with Chemotherapy, Alone or in Combination with Tetanus Toxoid, as Compared to
Chemotherapy Alone, in Patients With Metastatic Colorectal Adenocarcinoma.
Aventis
Dr.Richard Dalfen
TERMINATED
-McG 0231-
[THO 0216]
A Phase II Study of Concurrent and Adjuvant Administration of a Selective Inhibitor of COX-2,
Celecoxib, in the Treatment of Stages I/II Medically Inoperable Non-Small Cell Lung Cancer
(NSCLC) with Radiation.
Vanderbilt
Dr. Sergio Faria
TERMINATED
-McG 0301-
[1033-011]
A Phase II, Randomized, Open-Label Study of Single Agent CI-1033 in Patients With Metastatic
Breast Cancer.
Pfizer
Dr.Michael Pollak
WITHDRAWN
-McG 0302-
[CPTAIV-0020-411]
A Randomized, Multicenter Phase III Trial of Irinotecan in Combination with Three Different
Methods of Administration of Fluorophyrimidine: Infusional 5-FU (FOLFIRI), Bolus 5-FU (Day 1&
8), and Oral Capecitabine (Dal-14); with Celecoxib versus Placebo as First-Line Treatment for
Patients with Metastatic Colorectal Cancer.
Pharmacia
Dr. W.Miller
TERMINATED
-McG 0302pk-
[CPTAIV-0020-366]
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
Pharmacogenics Blood Sampling Protocol for Irinotecan/ Fluorouracil/ Leucovorin (CPT11/FU/LV).
Pharmacia
Dr. W.Miller
TERMINATED
-McG 0303-
[THAL-MM-003]
A Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study of
Combination Thalidomide Plus Dexamethasone Therapy Versus Dexamethasone Therapy Alone As
Induction Therapy For Previously Untreated Subjects With Multiple Myeloma.
Celgene Corporation
Dr. C. Shustik
TERMINATED
-McG 0304-
[CC-5013-MM-009]
A Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study of CC-5013
Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated
Subjects with Multiple Myeloma.
Celgene Corporation
Dr. C. Shustik
TERMINATED
-McG 0305-
[NO16966]
An Open-Label Randomized Phase III Study of Intermittent Oral Capecitabine in Combination with
Intravenous Oxaliplatin (Q3W) (“XELOX”) versus Bolus and Continuous Infusion
Fluorouracil/Intravenous Leucovorin with Intravenous Oxaliplatin (Q2W) (“FOLFOX4”) as Firstline Treatment for Patients with Locally Advanced or Metastatic Colorectal Cancer.
Roche Canada
Dr. R. Dalfen
NOT PARTICIPATING
-McG 0306-
[NO16967]
An Open-Label Randomized Phase III Study of Intermittent Oral Capecitabine in Combination with
Intravenous Oxaliplatin (Q3W) (“XELOX”) versus Bolus and Continuous Infusion
Fluorouracil/Intravenous Leucovorin with Intravenous Oxaliplatin (Q2W) (“FOLFOX4”) as
Treatment for Patients with Metastatic Colorectal Cancer who have Røeceived prior CPT-11 plus 5FU/LV as First Line Therapy.
Roche Canada
TERMINATED
Dr. R. Dalfen
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
-McG 0307-
[NO16968]
An Open-Label Randomized Phase III Study of Intermittent Oral Capecitabine in Combination with
Intravenous Oxaliplatin (Q3W) (“XELOX”) versus Fluorouracil/Leucovorin as Adjuvant Therapy
for Patients who have Undergone Surgery for Colon Carcinoma, UICC/AJCC Stage III (Dukes
Stage C).
Roche Canada
Dr. R. Dalfen
CLOSED
-McG 0308-
[201]
A Phase III Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, DoseTitration Study of Imidapril Hydrocholoride (EG006) in the Treatment of Cancer Cachexia.
Ark Therapeutics
Dr. B. Gagnon
TERMINATED
-McG 0309-
[20020163]
Multicentre, Double-blind, Randomised Phase 2 Trial Comparing Pegfilgrastim With Filgrastim
as an Adjunct to Chemotherapy for Acute Myeloid Leukaemia.
Amgen Canada
Dr. P. Laneuville
TERMINATED
-McG 0310-
[H7X-MC-JVAI]
A Phase 1 ½ Trial of LY900003 (3-Day Pretreatment Followed by 7-Day Infusion) Plus
Gemcitabine and Cisplatin in Patients with Advanced, Previously Untreated Non-Small Cell Lung
Cancer.
Eli Lilly
Dr. V. Hirsh
TERMINATED
-McG 0311-
[EFC4972 Xenox]
A multicenter randomized double-blind placebo controlled phase III study of the efficacy of
Xaliproden in reducing the neurtoxicity of the Oxaliplatin and 5-FU/LV combination in first-line
treatment of patients with metastatic colorectal carcinoma (MCRC)
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
Sanofi-Synthelabo
Dr. L. Panasci
TERMINATED
-McG 0312-
[NA17101C]
An Open-Label, Randomized, Multicenter, Phase II Study to Determine hemoglobin dose response,
Safety and Pharmacokinetic Profile of RO-503821 Given Subcutaneously Once Every 3 Weeks to
Anemic Patients with Stage IIIB or IV Non-Small Cell Lung Carcinoma Receiving Antineoplastic
Therapy.
Hoffman-La Roche
Dr. Vera Hirsh
TERMINATED
-McG 0313-
[BCIRG 103 (1839IL/0219)]
A Presurgical Study to Evaluate Molecular Alterations That Occur in Human Breast Cancer Tissue
and Normal Skin After Short Term Exposure to ZD 1839 (Iressa) and to Correlate These Alterations
with Pharmacokinetic Parameters.
BCIRG
Dr. Gerald Batist
TERMINATED
-McG 0314-
[IMN1207-003]
IRB #: A06-M48-03A
IMN1207 Versus Casein in the Prevention of Wasting Over Six Months During, or Following
Chemotherapy, Radiation or Surgery in the Treatment of Colorectal or Non-Small Cell Lung
Cancer: A Multicenter, Randomized, Double-Blind Study.
Immunotec Medical Corporation
Dr. Neil MacDonald
TERMINATED
-McG 0315-
NOT PARTICIPATING
-McG 0316 -
NOT PARTICIPATING
-McG 0317-
[BO17072]
An Open-Label, Multicenter, Randomized, Comparative, Phase III Study to Evaluate the Efficacy
and Safety of Rituximab Plus Fludarabine and Cyclophosphamide (FCR) Versus Fludarabine and
Cyclophosphamide Alone (FC) in Previously Treated Patients With CD20 Positive B-Cell Chronic
Lymphocytic Leukemia (CLL)
Hoffman-La Roche Pharmaceuticals
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
Dr. L. Shustik
-McG 0318-
TERMINATED
[H6H-MC- JEAM]
Randomized, Placebo-Controlled, Double-Blind, Phase 2 Study of Gemcitabine-Cisplatin
Combined with Two Different Doses of LY293111 or Placebo in Patients with Stage IIIB or IV
Non-Small Cell Lung Cancer.
Eli Lilly Canada
Dr. Vera Hirsh
TERMINATED
-McG 0319-
[EDOAGL-8725-001]
A Phase III, Randomized, Open-Label Study of IV Edotecarin vs. Temozolomide or Carmustine
(BCNU) or Lomustine (CCNU) in Patients With Glioblastoma Multiforme That Has
Progressed/Recurred After Alkylator-based (Neo)Adjuvant Chemotherapy.
Pharmacia
Dr. Kavan
TERMINATED
-McG 0320-
[P03247]
A randomized double-blind placebo controlled phase 3 study of temozolomide or placebo added to
whole brain radiation therapy for the treatment of brain metastases from non-small cell lung cancer.
Schering Canada
Dr. Luis Souhami
TERMINATED
-McG 0321-
[ ]
Use of 99Technetium-Labeled anti NRSA Fabs for Imaging in Small Cell Lung Cancer Patients.
Dr. Vera Hirsh
PENDING IRB SUBMISSION
-McG 0322-
[C017]
Promune TM (CPG 7909 Injection) in Combination with Chemotherapy in Patients with Advanced or
Metastatic Non-Small Cell Lung Cancer, a Randomized, Multi-Center, Controlled, Phase 2 Study.
Coley Pharmaceutical Group
Dr. Vera Hirsh
TERMINATED
-McG 0323-
[CPTK787 0133/304946]
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
A Randomized Double-Blind, Placebo-Controlled, Phase III Study of Oxaliplatin/5Fluorouracil/Leucovorin with PTK787/222584 or Placebo in Patients with Previously Treated
Metastatic Adenocarcinoma of the Colon or Rectum
Novartis
Dr. Wilson Miller
TERMINATED
-McG 0324A Phase I/II Study Using Pre-Operative High Dose Rate Brachytherapy for Patients with Advanced
Lower Rectal Cancer in Preparation for Sphincter Preservation Surgery.
Dr. Te Vuong
ACTIVE
-McG 0325-
[CPTK787 0135/306241]
A Randomized, Double-Blind, Placebo-Controlled, Phase III Study in Patients with metastatic
Adenocarcinoma of the colon of Rectum who are Receiving First-Line Chemotherapy with
Oxaliplatin/5 - fluorouracil/Leucovorin and PTK787/222584.
Novartis
TERMINATED
Dr. Wilson Miller
-McG 0327-
[CA163048]
A Phase III Trial of Novel Epothilone BMS-247550 Plus Capecitabine Versus Capecitabine Alone
in Patients with Advanced Breast Cancer Previously Treated with an Anthracycline and a Taxane
Bristol-Meyers Squibb
Dr. Wilson Miller
TERMINATED
-McG 0328-
[M02-416]
A Phase II Study Evaluating the Efficacy and Safety of ABT-751 in Patients with Renal Cell
Carcinoma.
Abbott
Dr. Simon Tanguay
TERMINATED
-McG 0329-
[1839IL/0704] [IMEX]
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
A Phase III, Randomized, Stratified, Parallel-Group, Multicentre, Comparative Study of ZD1839
(Iressa®) 250mg and 500mg versus Methotrexate for Previously Treated Patients with Squamous
Cell Carcinoma of the Head and Neck
AstraZeneca
Dr. Michael Pollak
TERMINATED
-McG 0330-
[]
A phase II study of Docetaxel and Platinum Chemotherapy concomitantly or sequentially with
Celebrex as a first line therapy for patients with locally advanced (stage IIIB) or Metastatic (stage
IV) Non-Small Cell Lung Cancer
Aventis Canada
Dr. Vera Hirsh
WITHDRAWN
-McG 0332-
[P03625]
A Phase II, Open-l, Study of CAELYX and Carboplatin in Platinum-Sensitive Relapsed Epithelial
Ovarian Cancer.
Schering Canada
Dr. Wilson Miller
TERMINATED
-McG 0401-
[RSR13 RT-016]
A Phase 3 Randomized, Open-Label Comparative Study of Standard Whole Brain Radiation
Therapy With Supplemental Oxygen, With or Without Concurrent RSR13 (efaproxiral), in Women
With Brain Metastases From Breast Cancer
Allos Therapeutics
Dr. L. Souhami
TERMINATED
-McG 0402-
[9238IL/0048]
A Randomized, Double-Blind, Multicenter Study to Compare the Efficacy and Tolerability of
Fulvestrant (FaslodexTM) Vs. Exemestane (AromasinTM) in Postmenopausal Women with
Hormone Receptor Positive Advanced Breast Cancer with Disease Progression After Prior NonSteroidal Aromatase Inhibitor (AI) Therapy.
AstraZeneca
Dr. Lawrence Panasci
TERMINATED
-McG 0403[CO23]
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
ProMune (CPG 7909 Injection) With or Without Chemotherapy for the Treatment of Stage III B/C
or IV Melanoma: A Randomized, Multi-Center, Open-Label, Parallel-Group, Active Controlled,
Phase II/III Study
Coley Pharmaceutical Group
Dr. Loutfi
WITHDRAWN BY COMPANY
-McG 0404-
[1839IL/0551] [INFACT]
A Randomized, Open-Label Phase II Study of ZD1839 (Iressa) Versus Gemcitabine and
Carboplatin in Chemotherapy-Naive Patients With Advanced (Stage IIIB or IV) Non-Small Cell
Lung Cancer and ECOG Performance Status 2.
AstraZeneca
Dr. Vera Hirsh
TERMINATED
-McG 0405-
[MNTX302]
A Double-Blind, Phase 3, Two-Week, Placebo-Controlled Study of Methylnaltrexone (MNTX) for
the Relief of Constipation due to Opioid Therapy in Advanced Medical Illness
Progenics Pharmaceuticals
Dr. Antonio Vigano
WITHDRAWN
-McG 0406-
[]
Prognostic Value of the Genetic and Biologic Determinants of Inflammation in Cancer Cachexia: A
Pilot Study
MUHC RI Pilot Project
Dr. Antonio Vigano
ACTIVE
-McG 0407-
[ ]
Prognostic Value of Clinical Correlates of Cancer Cachexia: A Prospective, Multicenter,
Population-Based Study. (A Study to Determine Whether Loss of Weight, Appetite and Function
are Associated With Length of Survival in Cancer Patients).
Dr. Antonio Vigano
ACTIVE
-McG 0408-
[SAKK 35-03]
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
Comparing Two Schedules of Rituximab Maintenance in Patients with de novo, Chemotherapy
resistant or Relapsed Follicular Lymphoma with Rituximab-Responding Disease: A Randomized
Phase III Trial
Roche
Dr. P. Laneuville
WITHDRAWN BY IRB
-McG 0409-
[393329/032 (BEXXAR)]
A single arm, open label, multicentre, phase II study of Tositumomab and Iodine I 131Tositumomab in subjects with indolent non-Hodgkin’s Lymphoma who have previously received
Rituximab.
GlaxoSmithKline
Dr. P. Laneuville
WITHDRAWN BY IRB
-McG 0410-
[1839IL/0721] [INTEREST]
[D791GC00001]
A Randomised, Open-Label, Parallel Group, International Multicenter, Phase III Study of Oral
ZD1839 (IRESSA®) Versus Intravenous Docetaxel (Taxotere®) in Patients with Locally Advanced
or Metastatic Recurrent Non-Small Cell Lung Cancer who have Previously Received PlatinumBased Chemotherapy
AstraZeneca
Dr. Vera Hirsh
TERMINATED
-McG 0411-
[M02-447]
A Phase II Study Of Abt-751 In Patients With Breast Cancer Refractory To Taxane Regimens
Abbott Pharmaceuticals
Dr. Lawrence Panasci
WITHDRAWN
-McG 0412-
[BMS CA225-045]
An Exploratory Pharmacogenomic Study of Cetuximab Monotherapy in Patients with Metastatic
EGRF Positive Colorectal Carcinoma
Bristol-Meyers Squibb
Dr. Mark Basik
TERMINATED
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
-McG 0413-
[XL119-001]
A Phase 3 Multicenter, Single-Blind, Randomized Study of XL119 versus 5-Fluorouracil (5-FU)
Plus Leucovorin (LV) in Subjects with Advanced Biliary Tumors Not Amenable to Conventional
Surgery
Exelixis
Dr. P. Kavan
TERMINATED
-McG 0414PARTICIPATING
-McG 0415-
MCGILL
NOT
[CA163080]
A Phase II Study in Patients Receiving BMS-247550 as Neoadjuvant Treatment for Breast Cancer
Bristol Myers-Squibb
Dr. M. Basik
WITHDRAWN BY COMPANY
Dr. M. Trudeau
-McG 0416-
[P30-302]
Multicenter Randomized Comparative Phase III Trial of Onconase + Doxorubicin vs. Doxorubicin
in Patients with Malignant Mesothelioma
Alfacell
Dr. V. Hirsh
DECLINED
BY
IRB-INVESTIGATOR
WITHDRAWN
-McG 0417-
[CZOL446EUS75] Z-PACT
A Prospective, Multicenter, Randomized, Phase II Study to Evaluate the Effects of Zometa in
Combination with Taxotere/Carboplatin in Patients with Stage IIIB-IV Unresectable Non-Small
Cell Lung Cancer
Novartis
Dr. V. Hirsh
TERMINATED
-McG 0418-
[XM-02-03-INT]
Safety and Efficacy of XM-02 in Patients with Small Cell or Non-Small Cell Lung Cancer
Receiving Platinum-Based Chemotherapy
BioGenerix
Dr. V. Hirsh
WITHDRAWN
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
-McG 0419Charting the course of Arm Morbidity in Breast Cancer: A prospective, Longitudinal Follow-Up
Dr. A. Towers
ACTIVE
-McG 0420-
[XRP9881B-3001] SOPRANO
A Randomized, Open-Label, Phase III study of RPRLO98811V Every 3 Weeks versus Capecitabine
(Xeloda ®) Tablets Twice Daily for 2 Weeks in 3-Week Cycles in Patients with Metastatic Breast
Cancer Progressing after Taxanes and Anthracycline Therapy
Aventis Pharma Inc.
Dr. L. Panasci
TERMINATED
-McG 0422-
[2686138-MMY-3001]
An International, Single Arm Protocol to Provide Expanded Access to Velcade for Patients with
Multiple Myeloma who have Received at Least Two Previous Lines of Therapy and are Refractory
to or have Relapsed after their Last Therapy for Multiple Myeloma
Ortho-BioTech
Dr. C. Shustik
TERMINATED
-McG 0423-
[BO17704] [AVAIL]
A Randomized, Double-Blind Multicenter 2-Stage Phase III Study of Bevacizumab in Combination
with Cisplatin and Gemcitabine versus Placebo, Cisplatin and Gemcitabine in Patients with
Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer, Who Have Not Received
Prior Chemotherapy.
Roche
Dr. Hirsh
CLOSED
-McG 0423 RG-
[BO17704 RG] [AVAIL]
A Randomized, Double-Blind Multicenter 2-Stage Phase III Study of Bevacizumab in Combination
with Cisplatin and Gemcitabine versus Placebo, Cisplatin and Gemcitabine in Patients with
Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer, Who Have Not Received
Prior Chemotherapy.
Roche
Dr. Hirsh
ACTIVE
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
-McG 0426-
[BMS CA180-005]
A Phase II Study of BMS-354825 in Subjects With Accelerated Phase Chronic Myeloid Leukemia
Resistant to or Intolerant of Imatinib Mesylate
BMS
Dr. C. Gambacorti
TERMINATED
-McG 0427-
[BMS CA180- ]
A Phase II Study of BMS-354825 in Subjects With Myeloid Blast Phase Chronic Myeloid
Leukemia Resistant to or Intolerant of Imatinib Mesylate
BMS
Dr. P. Laneuville
TERMINATED
-McG 0428-
[BMS CA180-015]
A Phase II Study of BMS-354825 in Subjects With Lymphoid Blast Phase Chronic Myeloid
Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Refractory to or
Intolerant of Imatinib Mesylate
BMS
Dr. P. Laneuville
TERMINATED
McG 0429
[CPTAIV-0020-357]
Phase II Study of Neoadjuvant 5-FU + Leucovorin + CPT-11 in Patients with Liver Metastases from
Colorectal Adenocarcinoma
Tom Baker Cancer Centre
Dr P Metrakos
TERMINATED
McG 0431
[CST1571ACA09]
An Open-Label, Randomized, Multicentre Study Comparing Gleevec (Imatinib) at Doses of 400mg
and 800mg in Obtaining Major Molecular Response in Chronic Phase Patients with Philadelphia
Chromosome Positive Chronic Myelogenous Leukemia That Have Reached a Complete Cytogenetic
Response During 400mg on Gleevec (Imatinib)
Novartis
Dr P Laneuville
TERMINATED
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
-McG 0432-
[BMS CA180-013]
A Phase II Study to Determine the Activity of BMS-354825 in Subjects With Chronic Phase
Philadelphia Chromosome Positive Chronic Myelogenous Leukemia Who Have Disease That is
Resistant to High Dose Imatinib Mesylate (Gleevec®) or Who Are Intolerant of Imatinib
BMS
Dr. S. Assouline
TERMINATED
-McG 0433-
[BMS CA180-017]
A Randomized Multi-Center Open Label Study of BMSs-354825 Vs Imatinib Mesylate (Gleevec®)
800 Mg/D in Subjects With Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid
Leukemia Who Have Disease That is Resistant to Imatinilenlidomideb at a Dose at 400 - 600 Mg/D
BMS
Dr. S. Assouline
TERMINATED
-McG 0502-
[100554]
A Phase III Randomized, Placebo-Controlled Study of Sorafenib in Patients with Advanced
Hepatocellular Carcinoma
Bayer
Dr. P. Metrakos
TERMINATED
-McG 0502LTF-
[12311 STEP]
Sorafenib Long Term Extension Program
Bayer
Dr. P. Metrakos
-McG 0503-
ACTIVE
[MO18024] [BEAT]
First-Line Bevacizumab and Chemotherapy in Metastatic Cancer of the Colon or Rectum: First
Beat (Bevacizumab Expanded Access Trial)
Dr. G Batist
Roche
TERMINATED
-McG 0504[CA225100]
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
A Randomized Multicenter phase ii study of gemcitabine/platinum/cetuximab versus
gemcitabine/platinum as first-line treatment for patients with advanced/metastatic non-small cell
lung cancer
Dr. V Hirsh
BMS/Imclone
TERMINATED
-McG 0505-
[CZOL446GCA08] “NEOCAN”
Randomized Multi-Center Study Comparing Prolonged Primary Systemic Endocrine Therapy with
Letrozole (Femara®) Alone or in Combination with Zoledronic Acid (zometa®) in Early Breast
Cancer (Neocan study)
Dr. L Panasci
Novartis
TERMINATED
-McG 0506-
[YMB 1002-02]
A Phase III Study of DPPE (Tesmilifene) Combined with Epirubicin and Cyclophosphamide versus
Epirubicin and Cyclophosphamide Alone as First-Line Treatment in Metastatic/Recurrent Breast
Cancer “The Dec Trial”
Dr L Panasci
YM BioSciences
COMPANY
WITHDRAWN
-McG 0507-
[3066K1-305-WW]
An Open-Label, Randomized, Phase 3 Trial of Intravenous Temsirolimus (CCI-779) at Two Dose
Levels Compared to Investigator’s Choice Therapy in Relapsed, Refractory Subjects with Mantle
Cell Lymphoma (MCL)
Dr. C Shustik
Wyeth Research
TERMINATED
-McG 0508-
[AHX-01-201]
An Open-Label Phase 2A Study in Subjects with Recurrent N-Cadherin Positive Advanced Solid
Tumors to Investigate the Safety and Efficacy of ADH-1 Administered Intravenously as a Single
Agent Once Every 3 Weeks
Protocol changed as of Version 2:
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
An Open-Label Phase 2A Study in Subjects With N-Cadherin Positive, Advanced or Recurrent
Solid Tumors to investigate the Safety and Efficacy of ADH-1 Administered Intravenously as a
Single Agent.
Dr. G Batist
Adherex Technologies
TERMINATED
-McG 0509-
[Q-CTG-01-V7.0]
A Multi-Center Phase II Study on Pre-Operative Administration of Gleevec in Patients with
Initially Non-Resectable Gastrointestinal Stromal Tumor (gist)
Dr. S Meterissian
Novartis
TERMINATED
-McG 0510-
[BO17706 AVITA ]
A Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Phase III Trial to Evaluate the
Efficacy and Safety of Adding Bevacizumab (Avastin) to Gemcitabine and Erlotinib in Patients
with Metastatic Pancreatic Cancer
Dr. Richard Dalfen
La Roche
TERMINATED
-McG 0511-
[11718]
Phase III Randomized, Placebo Controlled Study of Sorafenib in Repeated Cycles of 21 Days in
Combination with Paclitaxel/Carboplatin Chemotherapy in Subjects with Unresectable Stage III or
Stage IV Melanoma
Dr. W Miller
Onyx / Bayer
TERMINATED
-McG 0512-
[G-0029]
A Phase III Randomized, Open-Label Study of CG1940 and CG8711 versus Docetaxel and
Prednisone in Patients with Metastatic Hormone-Refractory Prostate Cancer Who are
Chemotherapy-Naïve
Dr. R. Rajan
Cell Genesys, Inc.
CLOSED
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
-McG 0513-
[HNBE-03-01]
A Randomized Trial Comparing Preservation of Function Status after Either Medpulser
Electroporation with Intratumoral Bleomycin Therapy or Surgery in Patients with Locally Recurrent
or Second Primary Squamous Cell Carcinoma of the Anterior Oral Cavity, Soft Palate, or Tonsil
That Have Failed Primary Curative Therapy
Dr. Shenouda
Genetronics, Inc.
TERMINATED
-McG 0514-
[HNBE-03-02]
A Randomized Trial Comparing Preservation of Function Status After Either Medpulser
Electroporation with Intratumoral Bleomycin Therapy or Surgery in Patients with Locally Recurrent
or Second Primary Squamous Cell Carcinoma of the Base of Tongue, Posterior Lateral Pharyngeal
Wall, Hypopharynx or Larynx that Have Failed Primary Curative Therapy
Dr. Shenouda
Genetronics, Inc.
TERMINATED
-McG 0515A Phase II Trial of Apecitabine and Gemcitabine in First-Line Treatment Of Metastatic Breast
Cancer
Dr. Lawrence Panasci
Groupe D’étude en Oncologie du Québec/Roche Canada/Eli Lilly Canada Inc.
TERMINATED
-McG 0516-
[L00070 IN 302 P1-2301 / CA183-004-009]
Prospective, Randomised Phase III Trial of I.V. Vinflunine Plus Best Supportive Care as Second
Line Therapy versus Best Supportive Care After a Platinum-Containing Regimen, in Patients With
Advanced Transitional Cell Carcinoma of Urothelial Tract
Dr. Steven Ades
Pierre Fabre Medicament and Bristol-Myers Squibb
TERMINATED
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
-McG 0517-
[BMS CA180-034]
IRB #: A00-M69-05B
A Randomized Two-By-Two, Multicenter, Open-Label Phase III Study of BMS-354825
Administered Orally at a Dose of 50 Mg or 70 Mg Twice Daily or 100 Mg Or 140 Mg Once Daily
in Subjects With Chronic Phase (CP) Philadelphia Chromosome or BCR-ABL Positive Chronic
Myelogenous Leukemia (Cml) Who are Resistant or Intolerant to Imatinib Mesylate (Gleevec®)
Dr. Carlo Gambacorti
Bristol-Myers Squibb
TERMINATED
Termination retracted: pt. stil on f/u
-McG 0518-
[BMS CA180-035]
IRB #: A00-M70-05B
A Randomized Two-Arm Multi-Center, Open-Label Phase II Study of BMS-354825 Administered
Orally at A Dose of 70 Mg Twice Daily or 140 Mg Once Daily in Subjects With Chronic
Myelogenous Leukemia in Accelerated Phase, in Myeloid or Lymphoid Blast Phase or With
Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or
Intolerant to Imatinib Mesylate (Gleevec).
Dr. Pierre Laneuville
Bristol-Myers Squibb
TERMINATED
-McG 0519-
[CC-5013-MM-016]
A Multicenter, Single-Arm, Open-Label Expanded Access Program for Lenalidomide Plus
Dexamethasone in Previously Treated Subjects With Multiple Myeloma
Dr. Chaim Shustik
Celgene Corporation
CLOSED
-McG 0520-
[ML19704]
A Phase I Trial of Tyrosine Kinase Inhibitor Erlotinib (Tarceva) With Limited Field Radiation for
Intermediate Prognosis Patients with Locally Advanced Non-Small Cell Lung Cancer
Dr. Vera Hirsh
Hoffmann-La Roche
ACTIVE
- McG 0520BM -
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
IRB #:
Revised:
2/17/2016
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McG Studies
Genetic and Serologic Determinants of Response to Erlotinib (Tarceva) plus Radiotherapy in
Patients with Intermediate Prognosis Locally Advanced Non-Small Cell Lung Cancer
Dr. Victor Cohen
ACTIVE
-McG 0521Clinical and Molecular Characteristics of Melanoma: A Retrospective Study
Catalin Mialcioiu
N/A
-McG 0522-
TERMINATED
[BAY 43-9006/11868] [PRISM]
Open Label, Non-Comparative Treatment Protocol for the Use of Sorafenib in Patients with
Advanced Renal Cell Carcinoma
Dr. Wilson Miller
Bayer Pharmaceuticals Corp.
TERMINATED
-McG 0522LTF-
[12311 STEP]
Sorafenib Long Term Extension Program
Bayer
Dr. W. Miller
-McG 0523-
ACTIVE
[DOXIL-MMY-2001]
A Phase II Study to Assess the Safety and Efficacy of DBD Combination Therapy (Doxil/Caelyx
[Doxorubicin Hcl Liposome Injection], Velcadetm [Bortezomib] and Dexamethasone) for Previously
Untreated Multiple Myeloma Patients.
Dr. Chaim Shustik
Ortho Biotech
TERMINATED
-McG 0524-
[CAMN107A2101]
IRB #: A00-M85-05A
A Phase IA/II Multicenter, Dose-Escalation Study of Oral AMN 107 on a Continuous Daily Dosing
Schedule in Adult Patients With Gleevec®-Resistant/Intolerant CML in Chronic or Accelerated
Phase or Blast Crisis, Relapsed/Refractory Ph+ All, and Other Hematologic Malignancies
Dr. Pierre Laneuville
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
Novartis
-McG 0525-
CLOSED
[Biomed 777-CLP-32]
Open Label Treatment and Survival Continuation Study of Atmestane Plus Tormifene versus
Letrozole in Advanced Breast Cancer
Dr. Wilson Miller
Intarcia Therapeutics Inc.
TERMINATED
-McG 0526-
[Pilot Study]
Evaluation of Group Remedial Exercises for Chronic Breast Cancer related Lymphedema
Dr. Anna Towers & Dr. Diane St-Pierre
N/A
-McG 0527-
WITHDRAWN
CTSU-N0147
A Randomized Phase III Trial Oxaliplatin (OXAL) Plus 5-Fluorouracil (5-FU)/Leucovorin (CF) with
or without Cetuximab (C225) after Curative Resection for Patients with Stage III Colon Cancer
Dr. Thierry Alcindor
NCIC coordinated by CTSU
-McG 0528
WITHDRAWN
[DACO-016]
Randomized Phase 3 Trial of Decitabine versus Patient’s Choice with Physicians’s Advice of either
Supportive Care or Low-Dose Cytarabine for the Treatment of Older Patients with Newly Diagnosed
Acute Myeloid Leukemia
Dr. Chaim Shustik
MGI Pharma Inc.
ACTIVE
-McG 0529Prospective Study of Serum VEGF as a Predictive and Prognostic Marker of Breast Cancer
Dr. Thierry Muanza
WITHDRAWN
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
-McG 0530-
[CEPO906A2303]
IRB #: A00-M03-06A
A Randomized, Parallel Group, Open-Label, Active Controlled, Multicenter Phase III Trial Of
Patupilone (EPO906) Versus Pegylated Liposomal Doxorubicin (Doxil®/Caelyx®) in
Taxane/Platinum Refractory/Resistant Patients With Recurrent Epithelial Ovarian, Primary
Fallopian or Primary Peritoneal Cancer
Dr. Walter Gotlieb
Novartis
-McG 0531-
ACTIVE
[A8501001]
IRB #: A00-M97-05B
International, Randomized, Open-Label, Phase 3, Trial of Paclitaxel/Carboplatin Plus PF-3512676
Versus Paclitaxel/Carboplatin Alone as First Line Treatment of Patients With Advanced Non-Small
Cell Lung Cancer
Dr. Vera Hirsh
Pfizer
-McG 0532-
TERMINATED
[MUH-MGH/RVH#05-092]
IRB #: A09-M66-05B
The value of EGG (Electrogastrogram) in Patients with the Anorexia/Cachexia Syndrome.
Dr. Martin Chasen
Investigator Initiated
-McG 0601
ACTIVE
(P04601)
IRB #: A00-M02-06A
A Phase II Trial of Continuous (28/28) Dose Intense Temozolomide Chemotherapy After
Progression On Conventional 5/28 Day Temozolomide In Patients With Recurrent Malignant
Glioma: The Temozolomide Rescue Study
Dr. Petr Kavan
Schering Canada Inc.
-McG 0602-
CLOSED
[C05005]
IRB #: A00-M11-06B
A Randomized, Non-comparative, Multicenter, Open-Label, Phase 2 Study of Tarceva® (erlotinib)
Alone and of Tarceva plus VELCADE® (bortezomib) for Injection in Patients with Relapsed or
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
Refractory, Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Dr. Vera Hirsh
TERMINATED
Millennium Pharmaceuticals
-McG 0603-
[CA225099]
IRB#:
A Randomized Multicenter Phase II Study of Taxane/Carboplatin/Cetuximab versus
Taxane/Carboplatin as First-Line Treatment for Patients with Advanced/Metastatic Non-Small Cell
Lung Cancer
Dr. Vera Hirsh
WITHDRAWN
BMS/ImClone
-McG 0604-
[STM01-102]
IRB #: A01-M10-06B
A Phase III, Randomized, Controlled Trial Of Myocet, Trastuzumab And Paclitaxel Versus
Trastuzumab And Paclitaxel For First Line Therapy Of Metastatic Breast Cancer
Dr. Gerald Batist
Sopherion Therapeutics Inc./Pharmanet
-McG 0605-
[HOG COE01]
CLOSED
IRB #: A02-M13-06B
Predicting Response And Toxicity In Patients Receiving Chemotherapy For Breast Cancer: A
Multicenter Genomic, Proteomic And Pharmacogenomic Correlative Study
Dr. Brian Leyland-Jones
Department of Defense
-McG 0606-
TERMINATED
[ARD6123
AVE-0005B/2001]
IRB #: A00-M18-06A
A Multicenter, Open-Label, Single-Arm, Two-Stage Study of the Efficacy and Safety of AVE0005
(VEGF Trap) Administered Intravenously every 2 Weeks in Patients with Platinum and ErlotinibResistant, Locally Advanced or Metastatic Non Small-Cell Lung Adenocarcinoma
Dr. Vera Hirsh
CLOSED
Sanofi Aventis
-McG 0607-
[CP02-0452]
IRB #:
Randomized Phase III study of Docetaxel or Premetrexed with or without Cetuximab in Patients
with Recurrent or Progressive Non-Small Cell Lung Cancer after Platinum-Based Therapy
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
Dr. Victor Cohen
ImClone
-McG 0608-
TERMINATED
[1839IL/0225]
IRB #: A02-M20-06A
A Phase II Randomised, Double-Blind, Stratified, Multi-Centre Trial Comparing The Nolvadex
20mg and Placebo Combination to Nolvadex™ 20mg and ZD1839 (Iressa™) 250mg Combination
in Patients with Metastatic Breast Cancer and Estrogen Receptor (ER) and/or Progesterone (PR)
Positive Tumours
Dr. Lawrence Panasci
AstraZeneca
-McG 0609-
WITHDRAWN
[E7389-G000-211]
IRB #: A03-M24-06B
A Phase II Open Label Single-Arm Study of E7389 in Patients with Locally Advanced or Metastatic
Breast Cancer, Previously Treated with Anthracycline, Taxane, and Capecitabine Therapy,
Refractory to the Last Prior Therapy for Their Disease
Dr. Wilson Miller
TERMINATED
Eisai Medical Research, Inc.
-McG 0610-
[Z9031]
IRB #:
A Phase III Randomized Study of Preoperative Radiation Plus Surgery Versus Surgery Alone for
Patients with Retroperitoneal Sarcomas (RPS)
Dr. David Roberge
American College of Surgeons Oncology Group (ACOSOG) WITHDRAWN
-McG 0611-
[CSTI571K2301] TOPS
IRB #: A04-M47-06A
A Randomized Open-Label Study of 400mg versus 800mg of Gleevec/Glivec (Imatinib Mesylate) in
Patients with Newly Diagnosed, Previously Untreated Chronic Myeloid Leukemia in Chronic Phase
(CML-CP) Using Molecular Endpoints
Dr. Pierre Laneuville
TERMINATED
Novartis
-McG 0612-
[PROFIT]
IRB #: A04-M48-06A
A Randomized Trial Of A Shorter Radiation Fractionation Schedule
Localized Prostate Cancer (Profit)
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
For The Treatment Of
Revised:
2/17/2016
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McG Studies
Dr. Luis Souhami
Ontario Clinical Oncology Group
-McG 0613-
[AVF3694g]
Ribbon 1
ACTIVE
(BO20094) IRB #: A04-M46-06A
A Multicenter, Phase III, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety
of Bevacizumab in Combination with Chemotherapy Regimens in Subjects with Previously
Untreated Metastatic Breast Cancer
Dr. Lawrence Panasci
CLOSED
Genentech
-McG 0614-
[D6997C00006 (9238IL/0068] IRB #: A04-M53-06B
[FINDER2]
A Randomized, Double-Blind, Parallel-Group, Multicentre, Phase II Study to Evaluate the Efficacy
and Tolerability of Fulvestrant (Faslodex™ \ 250 mg, Fulvestrant (Faslodex™) 250 mg (plus 250 mg
Loading Regimen) and Fulvestrant (Faslodex™) 500 mg in Postmenopausal Women with Oestrogen
Receptor Positive Advanced Breast Cancer Progressing or Relapsing after Previous Endocrine
Therapy
Dr. Lawrence Panasci
TERMINATED
AstraZeneca
-McG 0615-
BOI
IRB #: A06-M67-06A
Risks and Outcomes of Mucositis in Subjects Being Treated for Breast, Colorectal, Head and Neck,
Non-Small Cell Lung or Ovarian Cancers
Dr. Luis Souhami
CLOSED
Triad
-McG 0616-
[20050203 (AMG 954)]
IRB #: A05-M64-06B
A Randomized, Multicenter, Phase 3 Study to Compare the Efficacy of Panitumumab in
Combination with Oxaliplatin/ 5-Fluorouracil/ Leucovorin to the Efficacy of Oxaliplatin/ 5Fluorouracil/ Leucovorin Alone in Patients with Previously Untreated Metastatic Colorectal Cancer
Dr. Richard Dalfen
CLOSED
Amgen Canada Inc.
-McG 0617-
“MARINOL”
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
IRB #: A06-M68-06A
Revised:
2/17/2016
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McG Studies
A Double-Blind, Randomized, Placebo Controlled Clinical Trial to Evaluate the Efficacy of
Orexigenic Therapy with Delta-9-Tetrahydrocannabinol (THC) in Advanced Cancer Patients with
Chemosensory Abnormalities
Dr. Neil MacDonald
University of Alberta
-McG 0618-
CLOSED
[NH19960]
IRB #:
A Multicenter, Randomized, Open-Label Dose Finding Study of RO0503821 in Anemic Patients
with Stage IIIB or IV Non-Small Cell Lung Cancer Receiving First Line Myelosuppresive
Chemotherapy
Dr. Vera Hirsh
WITHDRAWN
Hoffmann-La Roche
-McG 0619-
[CA180-033]
IRB #: A06-M75-06A
Study of Dasatinib (BMS-354825) in Subjects with Chronic Myelogenous Leukemia with
Accelerated or Myeloid or Lymphoid Blast Phase or Philadelphia Chromosome Positive Acute
Lymphoblastic Leukemia who are Resistant to or Intolerant of Imatinib Mesylate
Dr. Pierre Laneuville
TERMINATED
Bristol-Myers Squibbø
-McG 0620-
DOCET_l_01799
IRB #: A12-M83-06B
Phase II Study of Neoadjuvant Taxotere, Cisplatin, and 5-Fluorouracil in Patients with Gastric or
Gastroesophageal Junction Adenocarcinoma
Dr. Steven Ades  Dr Lorenzo Ferri
ACTIVE
Investigator Initiated
-McG 0621-
[PV701.06.001]
IRB #: A09-M82-06B
A Multi-Center, Randomized (Two-Arm) Phase 2 Study of Intravenous PV701 in Combination with
Folfiri (Irinotecan and 5-Fluorouracil/Leucovorin) versus Folfiri Alone in Subjects with Advanced
Colorectal Cancer
Dr. Wilson Miller
TERMINATED
Wellstat Bilogics Corporation.
-McG 0622-
[EFC6125 AVE0005A/3001]
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
IRB #: A06-M71-06A
Revised:
2/17/2016
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Study of the Effect of
Intravenous AVE0005 (VEGF Trap) Administered Every 2 Weeks in Advanced Ovarian Cancer
Patients with Recurrent Symptomatic Malignant Ascites
Dr. Walter Gotlieb
CLOSED
Sanofi-aventis Canada Inc.
-McG 0623-
[ARD6122]
IRB #: A06-M70-06A
A Multicenter, Randomized, Double Blind, Parallel-Arm, Two-Stage Study of the Efficacy and
Safety of AVE0005 (VEGF Trap) Administered Intravenously Every 2 Weeks in Patients with
Platinum- Resistant and Topotecan-and/or Liposomal Doxorubicin-Resistant Advanced Ovarian
Cancer
Dr. Susie Lau
TERMINATED
sanofi-aventis Canada Inc.
-McG 0624-
[011-007] ASCENT-2
IRB #: A09-M94-06A
A Phase 3, Randomized, Open-Label Study Evaluationg DN-101 in Combination with Docetaxel in
Androgen-Independent Prostate Cancer (AIPC)
Dr. Wilson Miller
TERMINATED
Novacea
-McG 0625-
[CAMN107A2109]
IRB #: A09-M95-06A
An Open-Label, Multicenter, Expanded Access Study of Oral AMN 107 in Adult Patients with
Imatinib (Glivec®/Gleevec®) - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis,
Accelerated Phase or Chronic Phase
Dr. Pierre Laneuville
RE-ACTIVATED
Novartis
-McG 0626-
[CA183-001]
IRB #: A09-M96-06A
A Phase II Study of Intravenous (IV) Vinflunine in Patients with Locally Advanced or Metastatic
Transitional Cell (TCC) of the Urothelium (CA183001)
Dr. Steven Ades
TERMINATED
Bristol-Myers Squibb
-McG 0627-
[D1532C00003]
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
IRB #: A09-M101-06B
Revised:
2/17/2016
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McG Studies
A Phase II, Multi-Centre, Open-Label, Parallel Group, Randomized Study to Compare the Efficacy
of AZD6244 versus Temozolomide in Patients with Unresectable AJCC Stage 3 or 4 Malignant
Melanoma
Dr. Wilson Miller
TERMINATED
AstraZeneca
-McG 0628-
[M05-782]
IRB #: A10-M113-06B
A Phase 1/2 Study Evaluating the Safety and Efficacy of ABT-751 in Combination with Docetaxel
versus Docetaxel Alone in Subjects with Advanced or Metastatic Non-Small Cell Lung Cancer
Dr. Catalin Mihalcioiu
TERMINATED
Abbott Laboratories
-McG 0629-
[XRP6976J/3501]
IRB #: A09-M100-06B
A Multicenter, Open-Label, Randomized, Phase III Trial Comparing Immediate Adjuvant Hormonal
Therapy (ELIGARD-leuprolide acetate) in Combination with TAXOTERE Administered Every
Three Weeks versus Hormonal Therapy Alone versus Deferred Therapy Followed by the Same
Therapeutic Options in Patients at High Risk of Replapse after Radical Prostatectomy –
XRP6976J/3501 TAXOTERE (docetaxel)
Dr. Raghu Rajan
TERMINATED
Sanofi-aventis Canada Inc.
-McG 0630-
[CC-5013-CLL-001]
IRB #: A10-M108-06A
A Multi-Center, Open-Label, Randomized, Parallel-Group, Study of the Efficacy and Safety of Two
Lenalidomide Dose Regimens in Subjects with Relapsed or Refractory Chronic Lymphocytic
Leukemia
Dr. Chaim Shustik
TERMINATED
Celgene Corp.
-McG 0631-
[P04600]
IRB #: A11-M105-06A
INTRON A Health Management Program II
Dr. Petr Kavan
Schering Canada Inc..
-McG 0632-
PENDING ACTIVATION
[114-NH-301]
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
IRB #: A10-M116-06B
Revised:
2/17/2016
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McG Studies
A Phase III Randomized, Double-Blind Study of Galiximab in Combination with Rituximab
Compared with Rituximab in Combination with Placebo for the Treatment of Subjects with
Relapsed or Refractory, Follicular Non-Hodgkin’s Lymphoma
Dr. Chaim Shustik
Biogen Idec
-McG 0633-
CLOSED
[20050244]
IRB #: A11-M134-06B
A Randomized, Double-Blind, Multicenter Study of Denosumab Compared with Zoledronic Acid
(Zometa) in the Treatment of Bone Metastases in Subjects with Advanced Cancer (Excluding
Breast and Prostate Cancer) or Multiple Myeloma
Dr. Vera Hirsh
CLOSED
Amgen Inc.
-McG 0634-
[BRCA1+BRCA2]
IRB #:
A Randomized Phase II Pilot Trial of Carboplatin Compared to Docetaxel for Patients with
Metastatic Breast Genetic Breast Cancer
Dr. Marc Tischkowitz
PENDING IRB APPROVAL
University London College
-McG 0635-
[NOV-002-C301]
IRB #: A11-M125-06A
A Randomized, Open-Label, Phase 3 Trial of NOV-002 in Combination with Paclitaxel and
Carboplatin vs. Paclitaxel and Carboplatin Alone for the Treatment of Advanced Non-Small-Cell
Lung Cancer (NSCLC)
Dr. Vera Hirsh
TERMINATED
Novelos
-McG 0636-
[D4200C00044 “Zephyr”]
IRB #: A11-M126-06A
A Phase III, International, Randomized, Double-Blind, Parallel-Group, Multi-Center Study to Assess
the Efficacy of ZD6474 (ZACTIMA™) Plus Best Supportive Care versus Placebo Plus Best
Supportive Care in Patients with Locally Advanced or Metastatic (Stage IIIB – IV) Non-Small Cell
Lung Cancer (NSCLC) after Prior Therapy with an Epidermal Growth Factor Receptor Tyrosine
Kinase Inhibitor (EGFR TKI)
Dr. Vera Hirsh
CLOSED
AstraZeneca Canada Inc.
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
-McG 0637-
[MO19390] [“SAIL”]
IRB #: A12-M137-06A
An Open-Label Study of Bevacizumab (Avastin®) in Combination with Platinum-Containing
Chemotherapy as First-Line Treatment of Patients with Advanced or Recurrent Non-Squamous NonSmall Cell Lung Cancer
Dr. Vera Hirsh
CLOSED
Hoffmann-La Roche
-McG 0638-
[SAT2-05-07]
IRB #: A12-M138-06A
A Phase 2 Study Comparing Sequential Satraplatin and Erlotinib to Single-Agent Erlotinib in
Patients ≥ 70 Years of Age with Unresectable Stage 3 or 4 Non-Small Cell Lung Cancer as 1st-Line
Therapy
Dr. Vera Hirsh
TERMINATED
GPC Biotech Inc.
-McG 0639-
[CA180-044]
IRB #:
An Open-Label Randomized Phase III Study of Dasatinib vs. Standard-Dose (400 mg) Imatinib
Mesylate in the Treatment of Subjects with Chronic Phase Philadelphia Chromosome Positive
Chronic Myeloid Leukemia who have had a Suboptimal Response after 3-12 Months of Therapy
with ³ 400 mg Imatinib
Dr. Pierre Laneuville
WITHDRAWN
Bristol-Myers Squibb
-McG 0640-
[152-CL-201 LUCID]
IRB #: A12-M140-06B
A Randomized, Open-Label, Multicenter, Phase 2 Study to Evaluate the Safety and Efficacy of
Lumiliximab in Combination with Fludarabine, Cyclophosphamide, and Rituximab versus
Fludarabine Cyclophosphamide, and Rituximab Alone in Subjects with Relapsed Chronic
Lymphocytic Leukemia
Dr. Chaim Shustik
TERMINATED
Biogen Idec
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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-McG 0641-
[CRAD001C2240]
IRB #: A12-M141-006B
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Study to Compare the
Safety and Efficacy of RAD001 Plus Best Supportive Care (BSC) versus BSC Plus Placebo in
Patients with Metastatic Carcinoma of the Kidney which has Progressed on VEGF Receptor
Tyrosine Kinase Inhibitor Therapy
Dr.Raghu Rajan
CLOSED
Novartis
-McG 0701-
[MK869-130]
IRB #: A01-M01-07A
A Randomized, Double-Blind, Parallel-Group Study Conducted Under In-House Blinding
Conditions to Determine the Efficacy and Tolerability of Arepitant for the Prevention of
Chemotherapy-Induced Nausea and Vomiting Associated with moderately Emetogenic
Chemotherapy
Dr. Wilson Miller
TERMINATED
Merck Frosst Inc.
-McG 0702-
[E7389-G000-305] “EMBRACE”
IRB #: A01-M02-07A
A Phase III Open Label, Randomized Parallel Two-Arm Multi Center Study of E7389 versus
‘Treatment of Physician’s Choice’ in Patients wit Locally Recurrent or Metastatic Breast Cancer,
Previously Treated with at Least Two and a Maximum of Five Prior Chemotherapy Regimens,
Including an Anthracycline and a Taxane
Dr. Wilson Miller
Eisai Medical Research Inc.
-McG 0703-
CLOSED
[A6181108]
IRB #: A01-M03-07A
Phase 1/2 Open Label Trial of Sutent® (Sunitinib Malate) and Aromasin® (Exemestane) in the
First-Line Treatment of Hormone Receptor-Positive Metastatic Breast Cancer
Dr. Lawrence Panasci
TERMINATED
Pfizer
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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-McG 0704-
[EFC5505]
IRB #: A01-M04-07A
A Multicenter, Randomized, Double-Blind, Placebo Controlled, Phase III Study of the Efficacy of
Xaliprodren in Preventing the Neurotoxicity of Oxaliplatin in First-Line Treatment of Patients with
Metastatic Colorectal Cancer Treated with Oxaliplatin/5-FU/LV
Dr. Petr Kavan
CLOSED
sanofi-aventis Canada Inc.
-McG 0705-
[ELAAT]
IRB #: A01-M05-07A
A Randomized Comparison of Immediate versus Deferred Androgen Deprivation Therapy Using
Goserelin for Recurrent Prostate Cancer after Radical Radiotherapy (ELAAT)
Dr. Sergio Faria
ACTIVE
Ontario Clinical Oncology Group
-McG 0706-
[G060068]
IRB #:
A Randomized, Controlled Trial of TheraSphere versus Best Supportive Care for the Treatment of
Advanced Hepatocellular Carcinoma
Dr. David Valenti
WITHDRAWN
MDS Nordion Therapeutics
-McG 0707-
[C04-2]
IRB #: A01-M11-07B
A 2x2 Factorial, Randomized Phase III Study Comparing the Association of Oxaliplatin and
Capecitabine or Folinic Acid and 5-Fluorouracil With Avastin, and With or Without Tarceva® in the
Treatment Of Advanced Colon And Rectal Tumors.
Dr. Wilson Miller
CLOSED
GERCOR/Scimega/Dream Optimox
-McG 0708-
[CLBH589B2203]
IRB #: A02-M17-07A
A Phase II Study of Oral LBH589 in Adult Patients With Multiple Myeloma Who Have Received at
Least Two Prior Lines of Therapy and Whose Disease is Refractory to the Most Recent Line of
Therapy
Dr. Chaim Shustik
TERMINATED
Novartis Pharmaceuticals Canada Inc.
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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-McG 0709-
[A6181099]
IRB #: A02-M16-07A
A Randomized, Phase 3 Study Of Sunitinib In Combination with Capecitabine Compared with
Capecitabine in the Patients Previously Treated Breast Cancer
Dr. Wilson Miller
CLOSED
Pfizer Canada Inc
-McG 0710-
[]
IRB #: A03-M14-07A
A Phase II Open Label, Multi-Center Study with AVR118 In Anorectic Patients with Recurrent or
Advanced Malignancies
Dr. Martin Chasen
ACTIVE
Advanced Viral Research Corporation
-McG 0711-
[RAPID]
IRB #: A03-M21-07B
A Randomized Trial of Accelerated Partial Breast Irradiation: The Canadian Rapid Trial
Dr. Thierry Muanza
Institute for Health Research (CIHR) and the Canadian Breast
Cancer Research Alliance (CBCRA
-McG 0712-
[“ATHENA” – MO19391]
ACTIVE
IRB #: A02-M22-07B
Open-Label Study of Bevacizumab (Avastin®) Plus Taxane Monotherapy or in Combination for the
First-Line Treatment of Patients with Locally Recurrent or Metastatic Breast Cancer
Dr. Lawrence Panasci
Hoffmann-La Roche
-McG 0713-
CLOSED
[]
IRB #: A04-M35-07A
A Phase IB/II Trial of Combination Of Vinorelbine with Sorafenib (Bay 43-9006) as First-Line
Treatment In Patients With Metastatic Breast Cancer
Dr. Lawrence Panasci
ACTIVE
Investigator Initiated with Bayer Canada Inc.
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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-McG 0714-
[CLBH589B2202]
IRB #: A03-M25-07A
A Phase II Multicentre Study o Oral LBH9i Patients with Chronic Phase Chronic Myeloid Leukemia
Whose Disease is Resistant to at Least Two BCR-ABLTyrosine-Kinase Inhibitors
Dr. Carlo Gambacorti-Passerini
WITHDRAWN
Novartis Pharmaceuticals
-McG 0715-
[CLBH589B2211]
IRB #: A03-M26-07A
A Phase II, Multicentre Study of Oral LBH589 In Patients with Accelerated Phase or Blast Phase
(Blast Crisis) Chronic Myeloid Leukemia Whose Disease is Resistant to at Least Two BCR-ABL
Tyrosine-Kinase Inhibitors
Dr. Carlo Gambacorti-Passerini
WITHDRAWN
Novartis Pharmaceuticals
-McG 0716-
[OZM-006] TORCH
IRB #: A09-M27-07A
An International Multicenter Randomized Phase III Study of First-Line Erlotinib Followed by
Second-Line Cisplatin + Gemcitabine Versus First-Line Cisplatin + Gemcitabine Followed by
Second Line Erlotinib in Advanced Non-Small Cell Lung Cancer
Dr. Victor Cohen
CLOSED
University Health Network - Dr. Ronald Feld
-McG 0717-
[PBI-050706]
IRB #: A04-M36-07A
Effect of PBI-050706 in Cancer Patients Undergoing Chemotherapy and Developing Anemia FirstLine Treatment in Patients with Metastatic Breast Cancer
Dr. Michael Thirlwell
TERMINATED
Prometic Biosciences
-McG 0718-
[CA-042]
IRB #: A04-M37-07A
An Open-Label, Phase II Study of Weekly ABI-007 as First Line Therapy for Patients with
Metastatic Breast Cancer
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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Dr. Lawrence Panasci
Abraxis BioScience
-McG 0719-
CLOSED
[DOCET L 00909]
IRB #: A04-M39-07B
Rapid and Real-Time Patient-Reported Quality of Life (QOL) Measurement Using the Prostate
Cancer Symptom Scale (PSSC) in Docetaxel (Taxotere) Treated HRPC Patients
Dr. Raghu Rajan
Sanofi-Aventis
-McG 0720-
TERMINATED
[A6181111]
IRB #: A04-M40-07B
A Phase III Randomized, Double-Blind Study of Sunitib (SU011248, Sutent) versus Placebo in
Patients with Progressive Advanced/Metastatic Well-Differentiated Pancreatic Islet Cell Tumors
Dr. Peter Metrakos
Pfizer
-McG 0721-
ACTIVE
[CAMN107AX]
IRB #: A04-M41-07B
A Phase III Multi-Center, Open-Label, Randomized Study of Imatinib versus Nilotinib in Adult
Patients with Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous
Leukemia in Chronic Phase (CML-CP)
Dr. Pierre Laneuville
Novartis
TERMINATED
-McG 0722-
IRB #: A05-M47-07A
Tazarotene 0.1% Cream For the Treatment of Cutaneous T-Cell Lymphoma: A Prospective Study
Dr. Irna Turchin/Dr. David Roberge
-McG 0723-
[20050251]
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
ACTIVE
IRB #: A05-M48-07A
Revised:
2/17/2016
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McG Studies
A Phase 3 Randomized Trial of Chemotherapy with or without Panitumumab in Patients with
Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck
Dr. Adrian Langleben
Amgen
-McG 0724-
CLOSED
[BO20231B] AVEREL
IRB #: A08-M49-07B
A Randomized, Open-Label, Multi-Centre Study To Evaluate The Efficacy and Safety of
Bevacizumab (Avastin) in Combination with Trastuzumab (Herceptin®) and Docetaxel
(Taxotere®) Compared with Trastuzumab (Herceptin®) and Docetaxel (Taxotere®) Alone as FirstLine Treatment for Patients with Her-2 Positive Locally Recurrent or Metastatic Breast Cancer
Dr. Lawrence Panasci
Hoffmann-La Roche
-McG 0725-
ACTIVE
[CP043/06/FCNS]
IRB #: A05-M55-07B
A Multicentre, Placebo-Controlled, Double-Blind, Two-Phase Crossover Study of Nasalfent
(Fentanyl Citrate Nasal Spray) in the Treatment of Breakthrough Cancer Pain (BTCP) in Subjects
taking Regular Opioid Therapy
Dr. Michael Thirlwell
Archimedes Development/ Research
-McG 0726-
[CP045/06/FCNS]
WITHDRAWN
IRB #: A10-M56-07B
An Open-Label Study Investigating Long-Term Safety and Tolerability of Nasalfent (Fentanyl Nasal
Spray) in the Treatment of Breakthrough Cancer Pain (BTCP) in Subjects Taking Regular Opoid
Therapy
Dr. Michael Thirlwell
Archimedes Development
-McG 0727-
WITHDRAWN
MGCD0103-006
IRB #: A08-M57-07B
A Phase I/II Study of MGCD0103 (MG-0103) in Combination with Gemcitabine
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
Dr. Thierry Alcindor
MethylGene Inc
-McG 0728-
TERMINATED
[EFC6545] (PAPAYE)
IRB #:
A Multinational Randomized, Double-Blind, Study Comparing Efficacy and Safety of AVE0005
(VEGF Trap) versus Placebo in Combination with Gemcitabine in Patients with Unresectable
Advanced Pancreatic Cancer
Dr. Petr Kavan
Sanofi-Aventis
-McG 0729-
WITHDRAWN
(AVF3693g Ribbon 2 –
BO20094)
IRB #: A09-M59-07A
A Phase III, Multicentre, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety
of Bevacizumab in Combination with Chemotherapy Regimens in Subjects with Previously Treated
Metastatic Breast Cancer
Dr. Lawrence Panasci
Genentech
-McG 0730-
TERMINATED
MO19286 (Avex)
IRB #: A08-M68-07B
A Randomized, Open-Label Phase III Study to Assess Efficacy and Safety of Bevacizumab in
Combination with Capecitabine as First Line Treatment for Elderly Patients with Metastatic
Colorectal Cancer
Dr. Petr Kavan
TERMINATED
Hoffmann-La Roche
-McG 0731-
MEL11
IRB #: A09-M75-07A
Phase II Study of a Multiantigen Therapeutic Vaccine in Patients with Metastatic Melanoma
Dr. Catalin Mihalcioiu
Sanofi-Pasteur
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
CLOSED
Revised:
2/17/2016
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McG Studies
-McG 0732-
EFC10547
Vanilla
IRB #: A01-M74-07A
A Multinational, Randomized, Double-Blind Study, Comparing the Efficacy of Aflibercept Once
Every 2 Weeks versus Placebo in Patients Treated with Gemcitabine for Metastatic Pancreatic
Cancer
Dr. Petr Kavan
ON-HOLD
Sanofi-Aventis
-McG 0733-
UTSWRO.0701
IRB #:
A Randomized Phase II Study of Sorafenib in Combination with High Dose Chemoradiation in
Patients with Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC)
Dr. Vera Hirsh
UT Southwestern
-McG 0734-
WITHDRAWN
4783-08 Symmetry
IRB #: A01-M87-07A
A Randomized, Double-Blind, Phase 3 Trial of STA-4783 in Combination with Paclitaxel versus
Paclitaxel Alone for Treatment of Chemotherapy-Naïve Subjects with Stage IV Metastatic
Melanoma
Dr. Catalin Mihalcioiu
Synta Pharmaceuticals
-McG 0735-
CLOSED
20062080 [CONCERT1]
IRB #: A10-M89-07B
A Phase 2, Randomized Trial of Chemoradiation with or without Panitumumab in Subjects with
Unresected, Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Dr. Adrian Langeleben
Amgen
-McG 0736-
CLOSED
BO20289 (BEATRICE)
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
IRB #: A10-M90-07A
Revised:
2/17/2016
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McG Studies
An International Multi-Centre Open-Label 2-Arm Phase III Trial of Adjuvant Bevacizumab in Triple
Negative Breast Cancer
Dr. Lawrence Panasci
Hoffmann-La Roche
-McG 0737-
CLOSED
CA180-188
IRB #: A11-M97-07A
Dasatinib in Chronic Myelogenous Leukemia or Phailadelphia Chromosome Positive Acute
Lymphoblastic Leukemic Subjects who are Experiencing Clinical Benefit on Current START
Protocols: Long Term Safety and Efficacy Analysis
Dr. Pierre Laneuville
Bristol-Myers Squibb
-McG 0738-
ACTIVE
[3066K1-404-WW]
IRB #:
A Randomized Trial of Temsirolimus and Sorafenib as Second-Line Therapy in Patients with
Advanced Renal Cell Carcinoma who have Failed First-Line Sunitinib Therapy
Dr. Simon Tanguay/Francois Patenaude
Wyeth Research
-McG 0739-
[APM4074g]
ACTIVE
IRB #: A11-M99-07A
A Randomized, Double-Blind, Phase III Trial of Paclitaxel + Carboplatin + Bevacizumab with or
without Apomab in Patients with Previously Untreated, Advanced-Stage Non-Small Lung Cancer
Dr. Vera Hirsh
Genentech
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
CLOSED
Revised:
2/17/2016
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McG Studies
-McG 0740-
[A4061028]
IRB #: A11-M105-07B
A Randomized, Double-Blind Phase 3 Study of Gemcitabine plus AG-013736 versus Gemcitabine
plus Placebo for the First Line Treatment of Patients with Locally Advanced, Unresectable or
Metastatic Pancreatic Cancer
Dr. Richard Dalfen
Pfizer
-McG 0741-
TERMINATED
(never quite activated)
[20060283]
IRB #:
A Phase 2 Study of AMG 479 in Relapse or Refractory Ewing’s Family Tumours and Desmoplastic
Small Round Cell Tumours
Dr. Petr Kavan
Amgen
-McG 0742-
ACTIVE
[OTT 05-05 UOHI 2006-124]
IRB #: A11-M110-07A
A Phase 2 Randomized Study of Primary Prevention of Anthracycline-Induced Cardiotoxicity with
L-Carnitine in Patients with Breast Cancer.
Dr. Catalin Mihalcioiu
Canadian Institute of Health Research and the University of
Ottawa Heart Institute
-McG 0743-
[HBS701]
CLOSED
IRB #: A11-M109-07A
A Phase 1, Multi-center, Randomized, Double-Blind, Parallel, Placebo Controlled Study of the
Tolerability and Systemic Absorption of Menadione Topical Lotion as a Pre-emergent and Emergent
Treatment for Epidermal-Growth-Factor-Receptor (EGFR) Inhibitor-Associated Rash
Dr. Vera Hirsh
Hana Biosciences Inc.
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
CLOSED
Revised:
2/17/2016
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McG Studies
-McG 0744-
[D8480C00055 REGAL]
IRB #:
A Phase III Randomized, Parallel Group Multi-Centre study in Recurrent Glioblastoma Patients to
Compare the Efficacy of AZD2171 (RECENTIN) Monotherapy and the Combination of AZD2171
with Lomustine to the efficacy of Lomustine Alone
Dr. Petr Kavan
AstraZeneca
-McG 0745-
ACTIVE
[CRAD001C2324]
IRB #:
A Randomized Double-Blind Phase III Study of RAD001 10 mg/d Plus Best Supportive Care versus
Placebo Plus Best Supportive Care in the Treatment of Patients with Advanced Pancreatic
Neuroendocrine Tumor (NET)
Dr. Peter Metrakos
Novartis
-McG 0746-
CLOSED
[MK-0683-014 SAHA]
A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Oral Suberoylanilide
Hydroxamic Acid (L-001079038, MK-0683, Vorinostat) in Patients with Advanced Malignant
Pleural Mesothelioma Previously Treated with Systemic Chemotherapy
Dr. Vera Hirsh
Merck Frosst
-McG 0747-
ACTIVE
[P05048] “INFORM”
IRB #: A12-M118-07B
Randomized Phase II Multinational Trial to Evaluate the Safety of Two Chemotherapy plus
Trastuzumab Regimens as Adjuvant Therapy in Patients with HER2-positive Breast Cancer: Caelyx
+ Cyclophosphamide + Trastuzumab (C+C+H) or Doxorubicin + Cyclophosphamide (A+C), Each
Followed by Paclitaxel + Trastuzumab (T+H) BACH
Dr. Lawrence Panasci
Schering-Plough Canada Inc.
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
CLOSED
Revised:
2/17/2016
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McG Studies
-McG 0801-
[A6181114]
IRB #:
An Open-Label Sunitinib Malate (SU011248) Continuation Protocol for Patients who have
Completed a Prior Sunitinib Study and are Judged by the Investigator to Have the Potential to
Benefit from Sunitinib Treatment
Dr. Peter Metrakos
ACTIVE
Pfizer Canada Inc.
-McG 0802-
[CA031]
IRB #:
A Randomized, Phase III Trial of ABI-007 and Carboplatin Compared with Taxol® and
Carboplatin as First-line Therapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Dr. Vera Hirsh
CLOSED
Abraxis Bioscience Inc.
-McG 0803-
[]
IRB #:
Chemotherapy Or No Chemotherapy In Clear Margins After Neoadjuvant Chemoradiation In
Locally Advanced Rectal Cancer. A Randomised Phase III Trial Of Control vs. Capecitabine Plus
Oxaliplatin
Dr. Te Vuong
PENDING IRB APPROVAL
Cancer Research UK & UCL Cancer Trial Centre
-McG 0804-
[P04721]
IRB #: A02-M14-08A
A Fixed-Sequence, Open-Label Study to Determine the Activity of SCH 717454 as Assessed by
Positron Emission Tomography in Subjects With Relapsed or Recurrent Colorectal Cancer.
Dr. Petr Kavan
TERMINATED
Schering-Plough
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
-McG 0805-
[CC-4047-SCLC-002]
IRB #:
A Multicenter, Phase I/IIA, Open-Label, Dose-Escalation Study to Determine the Maximum
Tolerated Dose and to Evaluate the Safety Profile of CC-4047 Administered in Combination with
Cisplatin and Etoposide in Patients with Extensive Disease Small Cell Lung Cancer
Dr. Vera Hirsh
TERMINATED
Celgene Corp.
-McG 0806-
[MORAb-009-002]
IRB #:
A Phase 2 Randomized, Placebo-Controlled, Double-Blind Study Of The Efficacy of MORAb-009
in Combination With Gemcitabine In Patients with Advanced Pancreatic Cancer.
Dr. Gerald Batist
CLOSED
Morphotek Inc.
-McG 0807-
[PR88302] Pathway
IRB #:
A Prospective, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, International
Multicentre Phase III Trial Of PI-88 In The Adjuvant Treatment Of Post-Resection Hepatocellular
Carcinoma
Dr. Peter Metrakos
TERMINATED
Progen Pharmaceuticals
-McG 0808-
[ARQ 197-206]
IRB #:
A Randomized Phase 2 Study of ARQ 197 versus Investigator’s Choice of Second-Line
Chemotherapy in Patients with Locally Advanced or Metastatic Gastric Cancer Who Have
Progressive Neoplastic Disease Following Treatment with One Prior Chemotherapy Regimen
Dr. Petr Kavan
PENDING IRB APPROVAL
ArQule Inc.
-McG 0809-
[LISA]
IRB #:
Lifestyle Intervention Study In Adjuvant Treatment Of Early Breast Cancer
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
Dr. Lawrence Panasci
Ontario Clinical Oncology Group
-McG 0810-
[20060441]
WITHDRAWN
IRB #:
A Randomized, Double-Blind, Trial of AMG 745 Or Placebo For The Treatment Of Cachexia In
Subjects With Non-Small Cell Lung Cancer
Dr. Martin Chasen
WITHDRAWN
Amgen
-McG 0811-
[CDX-110-003]
IRB #: A00-M18-08A
A Phase II/III Randomized Study of CDX-110 with Radiation and Temozolomide in Patients with
Newly Diagnosed Glioblastoma Multiforme
Dr. Petr Kavan
TERMINATED
Celldex Therapeutics Inc.
-McG 0812-
[3160A4-3000-WW]
IRB #:
SKI-606
Phase 3 Randomized, Open-Label Study of Bosutinib versus Imatinib in Subjects with Newly
Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myelogenous Leukemia
Dr. Sarit Assouline
ACTIVE
Wyeth
-McG 0813-
[CC-4047-STSAR-001]
IRB #:
A Phase 2, Multicenter, Open-Label, Single-Arm, Two-Stage Study to Evaluate the Efficacy and
Safety of CC-4047 (Pomalidomide) in Patients with Advanced Soft Tissue Sarcomas Who Have
Relapsed or are Refractory to Systemic Anticancer Therapy
Dr. Thierry Alcindor
PENDING ACTIVATION
Celgene Corp.
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
-McG 0814-
[]
IRB #:
A Randomized, Double-Blind, Placebo-Controlled Multi-Center Study to Evaluate the Safety and
Efficacy of Fentanyl Sublingual Spray (Fentanyl SL Spray) for the Treatment of Breakthrough
Cancer Pain.
Dr. Martin Chasen
WITHDRAWN
Insys Therapeutics
-McG 0815-
[MPD-RC 106]
IRB #: A00-M50-08A
A Multicenter, Randomized, Blinded Efficacy and Safety Study of Pasireotide LAR vs Octreotide
LAR in Patients with Metastatic Carcinoid Tumors whose Disease-Related Symptoms are
Inadequately Controlled by Somatostatin Analogues
Dr. Jaroslav Prchal
PENDING IRB APPROVAL
-McG 0817-
[1200.23]
IRB#
Phase llB/lll Randomized, Double-Blind Trail of BiBw 2992 plus Best Supportive Care (BSC)
versus Placebo, plus BSC in Non-Small Cell Lung Cancer Patients Failing Erlotinib or Geftinib.
Dr. Vera Hirsh
Boehringer Ingelheim
-McG 0818-
ACTIVE
[P04715]
IRB#
A Randomized Phase 2 Study of SCH 727965 in Subjects with Relapsed or refractory mantle Cell
Lymphoma (MCL) or B-Cell Chronic Lymphocytic Leukemia (B-CLL).
Dr. Pierre Laneuville
Schering Canada Inc.
-McG 0819-
CLOSED
[COU-AA-301]
IRB #:
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630)
in Patient with Metastatic Castration Resistant Prostate Cancer who have Failed Docetaxel-Based
Chemotherapy
Dr. Raghu Rajan
CLOSED
Cougar Biotechnology Inc.
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
-McG 0820-
[MKC-103]
IRB #:
A Phase 2 Study of Oral MKC-1 Administered Twice Daily for 14 Consecutive days every 4 weeks
in Patients with Recurrent or resistant Epithelial Ovarian Cancer or Advanced Endometrial cancer.
Dr. Jeremy Sturgeon
TERMINATED
Mikana Therapeutics Inc
-McG 0821-
[CSOM230C2303]
IRB #: A05-M59-08A
A Multicenter, Randomized, Blinded Efficacy and Safety Study of Pasireotide LAR vs Octreotide
LAR in Patients with Metastatic Carcinoid Tumors whose Disease-Related Symptoms are
Inadequately Controlled by Somatostatin Analogues.
Dr. Juan Rivera
ACTIVE
Novartis
-McG 0822-
[26866138-MMY-3020]
IRB #:
An International Single-Arm Study to Provide Further Safety and Efficacy Data on the
VELCADE/Melphalan/Prednisone Regimen in Previoslu Untreated Transplant ineligible Multiple
Myeloma Patients.
Dr. Chaim Shustik
Ortho Biotech
-McG 0823-
PENDING ACTIVATION
[AP23573-07-302]
IRB #:
A Pivotal Trial to determine the Efficacy and Safety of AP23573 when administered as Maintenance
Therapy to patients with Metastatic Soft-Tissue or Bone Sarcomas.
Dr. Thierry Alcindor
ACTIVE
ARIAD Pharmaceuticals, Inc.
-McG 0824-
[A4021020]
IRB #:
A Phase 1/Phase 2 Study of CP-751, 871 in Patients with relapsed and/or Refractory Ewing’s
Sarcoma Family of Tumors
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
Dr. Petr Kavan
Pfizer Canada Inc.
-McG 0825-
TERMINATED
[EMR 63325-001 (START)]
IRB #: A08-M66-08B
A Multi-Center Phase III Randomized, Double-Blind Placebo- Controlled study of the Cancer
Vaccine Stimuvax (L-BLP25 or BLP25 Liposome Vaccine) in Non-Small cell Lung Cancer
(NSCLC) Subjects with Unresectable Stage III Disease
Dr. Vera Hirsh
TERMINATED
Merck KgaA and EMD Serono, Inc.
-McG 0826-
[GEM017]
IRB #: A06-M76-08A
A Phase 1 Followed by a Randomized, Phase 11 Study of Carboplatin and Etoposode with or
without Obatoclax Administered every 3 weeks to Patients with Extensive-Stage Small Cell Lung
Cancer (ES-SCLC)
Dr. Vera Hirsh
CLOSED
Gemin X
-McG 0827-
[H6Q-MC-JCBJ]
IRB #:
PRELUDE: A Phase 3 Clinical Study to investigate the Prevention of Relapse in Lymphoma Using
Daily Enzastaurin.
Dr. Sarit Assouline
ACTIVE
Eli Lilly & Company
-McG 0828-
[D0810C00020] PARP
MP#: CHUM-08.44
Phase II, Open Label, Non-Randomized Study of AZD2281 in the Treatment of Patient with Known
CRCA or Recurrent High Grade Serious/Undifferentiated Tubo-Ovarian Carcinoma and in Known
BRCA or Triple Negative Breast Cancer to Determine Response Rate and Correlative Markers of
Response
Dr. Marc Tischkowitz
CLOSED
AstraZeneca
Lead PI: Dr. Andre Robidoux (Notre-Dame Hospital)
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
-McG 0829-
[D2782C00010]
MP#: CHUQ-HD-08-003
A Phase II, Single Agent, Mutilcentre, Adaptive 2-Stage Study to Evaluate the Efficacy, Safety and
Pharmacokinetics of AZD4877 Administrered Weekly in Patients with Recurrent Advanced
Urothelial Cancer
Dr. Jeremy Sturgeon
PENDING IRB APPROVAL
AstraZeneca
Lead PI: Dr. Fradet (Centre de Recherche Clinique et
Evaluative en Oncologie CHUQ – Hotel-Dieu de Quebec)
-McG 0830-
[TLN-4601-201]
MP#: CHUM-08.006
A Phase II Study of TLN-4601 in Patients with Glioblastoma Multiforme
Dr. Petr Kavan
Thallion Pharma
Lead PI: Karl Belanger (Notre-Dame Hospital)
TERMINATED
-McG 0831-
[A6181120]
MP#: CHUM-08.042
(AP3213-US study)
A Multicenter, Randomized, Double-Blind, Phase 3 Study Of Sunitinib Plus Prednisone Versus
Prednisone In Patients With Progressive Metastatic Hormone-Refractory Prostate Cancer After
Failure Of A Docetaxel-Based Chemotherapy Regimen.
Dr. Raghu Rajan
ACTIVE
Pfizer
Lead PI: Dr. Fred Saad (Notre-Dame Hospital)
-McG 0832-
[NO21746]
IRB #: A09-M90-08A
An Open Label Study to Determine the effect of R1507 (RO4858696) plus Tarceva (Erlotinib) on
Progression-Free Survival in Patients wit Stage IIIB/IV Non-Small Lung Cancer with Progressive
Disease after Clinical Benefit to Second or Third Line Erlotinib Monotherapy.
Dr.VeraHirsh
TERMINATED
Hoffmann-La Roche
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
-McG 0833-
[]
IRB #:
High Dose Rate Brachytherapy Alone as the primary Therapy of Low Risk Endometrial Carcinoma
in Elderly Women
Dr. Luis Souhami
ACTIVE
Investigator Initiated
-McG 0834-
[INS-06-007]
IRB #: A09-M97-08B
Open – Label Multi-Center Safety Trial of Fentanyl Sublingual Spray (Fentanyl SI Spray) for the
Treatment of Breakthrough Cancer Pain.
Dr. Martin Chasen  Dr Michael Thirlwell
ACTIVE
Insys Therapeutics Inc.
-McG 0835-
[N0574]
IRB #:
Phase III Randomized Trial of the Role of Whole Brain Radiation Therapy in Addition to
Radiosurgery in Patients with One to Three Cerebral Matastases.
Dr. David Roberge
PENDING ACTIVATION
North Central Cancer Treatment Group (NCCTG)
-McG 0836-
[007]
IRB #:
An Open-Label, Randomized, PhaseI/IIA Trial Evaluation MK-0646 in Combination with Erlotinib
(TARCEVA) for Patients with Recurrent Non-Small Cell Lung Cancer.
Dr. Vera Hirsh
TERMINATED
Merck Frosst
-McG 0837-
[CRAD001L2401]
MP #: CHUM-08.130
An open-label, multi-center, expanded access study of RAD001 in patients with metastatic
carcinoma of the kidney who have progressed despite vascular endothelial growth factor receptor
tyrosine kinase inhibitor therapy
Dr. Wilson Miller
ACTIVE
Novartis
Lead PI: Dr. Denis Souliere ((Notre-Dame Hospital)
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
-McG 0838-
[Investigator-Intiated]
IRB # A10-M108-08B
A Phase II Study of Hair Sparing Intensity Modulated Whole Brain Radiotherapy Pulse Topical
Tempol in the Treatment of Brain Matastases.
Dr. David Roberge
ACTIVE
-McG 0839-
[20060392] “STARS”
MP #: JGH-08-112
Prospective Multi-National Observational Study to Assess Health Resource Utilization Associated
with Skeletal Related Events in Patients with Bone Metastases Secondary to Breast, Prostate, or
Lung Cancer, or Multiple Myeloma
Dr. Lawrence Panasci
Amgen
-McG 0840-
ACTIVE
[OSI 774-302 - RADIANT]
IRB #: A11-M110-08A
A Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Single-Agent
Tarceva (Erlotinib) Following Complete Tumour Resection with or without Adjuvant Chemotherapy
in Patients with Stage lB-lllA Non-Small Cell Lung Carcinoma who have EGFR-Positive Tumors.
Dr. Jason Agulnik
OSI Pharmaceuticals
-McG 0841-
ACTIVE
[CA184-029]
IRB #: A11-M118-08B
Adjuvant Immunotherapy with Anti-CTLA-4 Monoclonal Antibody (Ipilimumab) versus Placebo
after Complete Resection of High-Risk Stage III Melanoma: A Randomized, Double-Blind Phase 3
Trial of the EORTC Melanoma Group.
Dr. Wilson Miller
Bristol-Myers Squibb
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
ACTIVE
Revised:
2/17/2016
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McG Studies
-McG 0842-
[EGF 110656 – LOGICTRIO- 013]
IRB #:
A Phase III Study of ERBBS Positive Advanced or Metastatic Gastric or Esophageal or
Gastroesophageal Junction Adenocarcinoma Treated with Capecitabine plus Oxaliplatin with or
without Lapatinibø
Dr. Wilson Milller
ACTIVE
GlaxoSmithKline
-McG 0843-
[EMD 121 974-011
CENTRIC]
IRB #:
Cilengitide in Subjects with Newly Diagnosed Glioblastoma Mutliforme and Methylated MGMT
Gene Promoter – A Multicenter, Open-Label, Controlled Phase III Study, Testing Cilengitide in
Combination with Standard Treatment (Temozolomide with Concomitant Radiation Therapy,
Followed by Temozolomide Maintenance Therapy) versus Standard Treatment Alone
Dr. Thierry Muanza
WITHDRAWN
Merck KGaA
-McG 0844-
[OP-103P]
IRB #: A12-M127-08A
A Phase I/II Clinical Study Using Pentamidine in Patients with Locally Advanced or Metastatic
Pancreatic Cancer Undergoing Standard Therapy
Dr. Petr Kavan
ACTIVE
Oncozyme Pharma Inc.
-McG 0845-
[NO21160]
IRB #:
A Randomized, Double Blind Study to Determine the Effect of Two Dose Schedules of R1507 or
Placebo, Both in Combination with Erlotinib (Tarceva®), on Progression-Free Survival in Patient
with Advanced Non-Small Cell Lung Cancer with Disease Progression after First or Second-Line
Chemotherapy
Dr. Vera Hirsh
TERMINATED
Hoffmann-La Roche
-McG 0846-
[EPO-ANE-3018]
IRB #:
A Study Evaluating Epoetin Alfa 40,000 IU Every Week or 80,000 IU Every Week Compared to
Placebo in Patients with Low or Intermediate-1 Risk Myelodysplastic Syndromes at Risk for
Transfusion
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
Dr. John Storring
Johnston & Johnston Pharmaceutical
-McG 0847-
[CAMN 107G2301]
CLOSED
MP #: HMR-08-007
A Randomized, open-label, multi-center phase III study to evaluate the efficacy and safety of
nilotinib versus imatinib in adult patients with unresectable or metastatic gastrointestinal stromal
tumors (GIST)
Dr. Petr Kavan
Novartis
Lead PI: Dr. Lucas Sideris (Hopital Maisonneuve-Rosemont)
ACTIVE at MGH, RVH and JGH
-McG 0901-
IRB#
[1230.5]
A Randomized, Open-Label Phase II Trial of BI 6727 Monotherapy and BI 6727 in Combination
with Standard Dose Pemetrexed Compared to Pemetrexed Monotherapy in Second Line Non-Small
Cell Lung Cancer
Dr. Vera Hirsh
ACTIVE
Boehringer Ingelheim
-McG 0902-
[HBS407]
IRB#
A Phase 2 Study to Evaluate the Safety and Efficacy of Weekly Doses of Marqibo® (Vincristine
Sulfate Liposomes Injection) in Adult Patients with Philadelphia Chromosome-Negative Acute
Lymphoblastic Leukemia (ALL) in Second Relapse or Adult Patient with Philadelphia
Chromosome-Negative ALL who Failed Two Treatment Lines of Anti-Leukemia Chemotherapy
Dr. Sarit Assouline
Hana Bio Sciences
-McG 0903-
CLOSED
[20060198]
IRB# A01-M03-09A
A Randomized, Double-Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of
Romiplostim Treatment of Thrombocytopenia in Subjects with Low or Intermediate-1 Risk
Myelodysplastic Syndrome (MDS)
Dr. John Storring
Amgen
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
ACTIVE
Revised:
2/17/2016
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McG Studies
-McG 0904-
[TRIO 014]
IRB#
A Randomized, Double-Blind, Placebo Controlled, Multicentre, Phase II Study of Adding AMG
479, a Fully Human Monoclonal Antibody Against Insulin-Like Growth Factor Type 1 Receptor
(IGF-1R) to First Line Chemotherapy in patient with Optimally Debulked (<1cm) Epithelial Ovarian
Cancer
Dr. Walter Gotlieb
ACTIVE
Transitional Research in Oncology
-McG 0905-
[TRIO 015]
IRB#
A Multicenter, Open Label, Phase II Study of the Efficacy and Safety of AMG 479, a Full Human
Monoclonal Antibody Against Insulin-Like Growth Factor Type 1 Receptor (IGF-1R) as Second
Line Therapy in patients with Recurrent Platinum Sensitive Ovarian Cancer
Dr. Walter Gotlieb
Transitional Research in Oncology
ACTIVE
-McG 0906-
[AMR PH GL 2007 CL 001]
IRB#
ACT 1
A Randomized, Open-Label, Multination Phase 3 Trials of Comparing Amrubicin versus Topotecan
in Patients with Extensive or Limited and Sensitive or Refractory Small Cell Lung Cancer after
Failure of First-Line Chemotherapy.
Dr. Vera Hirsh
TERMINATED
Celgene Corp.
-McG 0907-
[AP23573-07-205]
IRB#
A Randomized Phase II Trial of Deforolimus (AP23573; MK-8669) Compared to Progestin in
Female Adult Patients with Advanced Endometrial Carcinoma Following One Line of
Chemotherapy
Dr. Susie Lau
ACTIVE
Ariad
-McG 0908-
[BO20603]
IRB#
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase III Trial Comparing the
Efficacy of Bevacizumab in Combination with Rituximab and CHOP (RA-CHOP) versus Rituximab
and CHOP (R-CHOP) in Previously Untreated Patients with CD20-Positive Diffuse Large B-Cell
Lymphoma (DLBCL)
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
Dr. Chaim Schustik
Hoffmann-La Roche
-McG 0909-
ACTIVE
[114-NH-302]
IRB#
A Phase II, Open-Label, Multicenter, Single-Arm, Retreatment Study of Galiximab in Combination
with Rituximab for Subjects with Relapsed, Follicular Non-Hodgkin’s Lymphoma who Previously
Responded on Study 114-NH-301
Dr. Chaim Schustik
PENDING IRB APPROVAL
Biogen idec.
-McG 0910-
[CAMN107A2405]
IRB# A03-M37-09A
An Open-Label, Randomized Study of Nilotinib vs. Standard Imatinib (400/600 mg QD) Comparing
the Kinetics of Complete Molecular Response for CML-CP Patients with Evidence of Persistent
Leukemia by RQ-PCR
Dr. Pierre Laneuville
ACTIVE
Novartis
-McG 0911-
[M10-440]
IRB#
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Evaluating the Efficacy of ABT-888 in
Combination with Temozolomide versus Temozolomide Alone in Subjects with Metastatic
Melanoma
Dr. Catalin Mihalcioiu
CLOSED
Abbott
-McG 0912-
[]
IRB#
A Prospective Study Assessing the Predictive Value of TMPRSS2-ERG Gene Fusion in High Risk Prostate
Cancer Patients
Dr. Niazi
AstraZeneca (MSSS?)
-McG 0913-
PENDING IRB SUBMISSION
[A10-763]
IRB#
A Phase II Study of Adjuvant/Salvage Androgen Suppression plus Radiation Therapy for High-Risk
Localized Adenocarcinoma of the Prostate
Dr. Tamin Niazi
PENDING IRB APPROVAL
Investigator Initiated
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
-McG 0914-
[N/A]
IRB#
Multicenter Open-Label Single Arm Phase IB/II Trial of the Combination of Lapatinib, Doxil and
Vinorelbine as First Line Treatment for HER-2+ Metastatic Breast Cancer Patients
Dr. Lawrence Panasci
WITHDRAWN
Investigator Initaited
-McG 0915-
[CLTR0308-204]
IRB#
Phase Iib, Multicenter, Randomized, Open Label, Trial, Of Cpx-351 (Cytarabine:Daunorubicin)
Liposome Injection Versus Cytarabine And Daunorubicin In Patients With Untreated Aml 60-75
Years Of Age
Dr. John Storring
CLOSED
Celator Pharmaceuticals Inc.
-McG 0916-
[BO21977 / TDM4370G]
IRB#
A Randomized, Multicenter, Phase III Open-Label Study of the Efficacy and Safety of TrastuzumabMCC-DM1 vs. Capecitabine + Lapatinib in Patients with HER2-Positive Locally Advanced or
Metastatic Breast Cancer who have Received Prior Trastuzumab-Based Therapy
Dr. Wilson Miller
ACTIVE
Roche/Genentech
-McG 0917-
[N/A]
IRB#
A Multicentre, Open-Label Phase I/II of CEP-701 (Lestaurtinib) in Adults with Meylofibrosis
Dr Jaroslav Prchal
Myeloproliferative Disorders Research Consortium
-McG 0918-
[PR104-2003]
PENDING IRB SUBMISSION
IRB#
A Randomized Phase II, Multi-Center, Open-Label Trial of PR104 and Docetaxel in Patients with
Advanced Non-Small Cell Lung Cancer
Dr. Vera Hirsh
TERMINATED
Pro-Acta
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
-McG 0919-
[OXALI_L_03943]
IRB#
A Phase II study of modified Folfox-6 chemotherapy as 1st-line treatment of metastatic colorectal
cancer in patients who have received oxaliplatin-based adjuvant chemotherapy
Dr. Thierry Alcindor
TERMINATED
Sanofi-Aventis
-McG 0920-
[SG035-0003]
IRB#
A pivotal study of SGN-35 in treatment of patients with relapsed or refractory Hodgkin lymphoma
(HL)
Dr. John Storring
CLOSED
Seattle Genetics
-McG 0921-
[MK-0822-029]
IRB#
A Phase III Study to Assess the Tolerability and Efficacy of MK-0822 (Odanacatinib) in Reducing
the Risk of Bone Metastases in Women with Breast Cancer
Dr. Catalin Mihalcioiu
PENDING IRB SUBMISSION
On-Hold by Merck
Merck
DO NOT SUBMIT YET
-McG 0922-
[CC-5013-CLL-002]
IRB#
A Phase 3, Multi-Center, Randomized, Double Blind, Placebo-Controlled, Parallel-Group Study Of
The Efficacy And Safety Of Lenalidomide (Revlimid®) As Maintenance Therapy For Patients With
B-Cell Chronic Lymphocytic Leukemia Following Second-Line Therapy
Dr. Chaim Shustik
PENDING ACTIVATION
Celgene
-McG 0923-
[YMB1000-018]
IRB#
Randomized, Phase II, Double-Blind Study of Nimotuzumab Plus Whole-Brain Radiation Therapy
(WBRT) Compared with WBRT Alone in Patients with Brain Metastases from Non-Small Cell
Lung Cancer
Dr. Luis Souhami
PENDING IRB APPROVAL
YM Biosciences
-McG 0924-
[098-02]
IRB#
A Multicenter Phase Ib Trial to Determine Whether a Gene Expression Signature Changes in
Response to Treatment with Bcr-Abl Inhibitors in Patients with Blast Phase Philadelphia
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
Chromosome Positive Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute
Lymphocytic Leukemia
Dr. Pierre Laneuville
PENDING ACTIVATION
Merck
-McG 0925-
[3144A2-3003-WW]
IRB#
A Phase 3, Randomized, Open-Label Study of Neratinib Versus Lapatinib plus Capecitabine for the
Treatment of ErbB-2 Positive Locally Advanced or Metastatic Breast Cancer
Dr. Lawrence Panasci
PENDING IRB APPROVAL
Wyeth
-McG 0926-
[]
IRB#
Randomized Phase III Study of the IGF-1R Antagonist R1507 vs. Placebo in Combination with
Gemcitabine and Erlotinib in the Treatment of Patients With Metastatic Pancreatic Adenocarcinoma
Dr. TBA
WITHDRAWN BY COMPANY
Roche
-McG 0927-
[CHR-2797-038]
IRB#
A Phase II single-arm Study to Evaluate the Efficacy, Safety and Tolerability of CHR-2797 in
Elderly Patients with Treatment Refractory or Relapsed Acute Myeloid Leukemia
Dr. John Storring
ACTIVE
Chroma Therapeutics
-McG 0928-
[CRAD001Y2301]
IRB#
A Randomized Double-Blind, Placebo-Controlled Study of Everolimus in Combination with
Exemestane in the Treatment of Postmenopausal Women with Estrogen Receptor Positive Locally
Advanced or Metastatic Breast Cancer who are refractory to Letrozole or Anastrozole
Dr. Lawrence Panasci
Novartis
-McG 0929-
Multicentre Mechanism
[BI 1200-36]
IRB#
BIBW 2992 With or Without Daiy Temozolomide in the Treatment of Patients with Recurrent
Malignant Glioma
Dr. Petr Kavan
Being Submitted by MNI CRU
Boehringer Ingelheim MNI STUDY – NOT MCGILL
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
-McG 0931-
[13266)
IRB# A05-M72-09B
A Phase III, Multicenter, placebo-controlled trial of Sorafenib (BAY 43-9006) in patients with
relapsed or refractory advanced predominantly non Squamous Non-Small Cell Lung Cancer
Dr. Vera Hirsh
ACTIVE at MGH & RVH
Bayer
-McG 0932-
[CRAD0001N2301]
IRB#
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study Of RAD001
Adjuvant Therapy In Poor Risk Patients With Diffuse Large B-Cell Lymphoma (DLBCL) Of
RAD001 Versus Matching Placebo after Patients have Achieved Complete Response With FirstLine Rituximab-Chemotherapy.
Dr. Laneuville
ACTIVE
Novartis
-McG 0933-
[CBP 08-02 (CANBAS)
IRB#
Phase II Study of a Triplet Combination of CBP501, Pemetrexed and Cisplatin as First-Line
Treatment in Patients with Locally Advanced Stage IIIB with Malignant Pleural Effusion or
Pericardial Effusion) or Metastatic (Stage IV) Non-Squamous NSCLC
Dr. Vera Hirsh
ACTIVE
CanBas
-McG 0934-
[CA033]
IRB#
An Open Label, Multicenter, Phase III Trial Of ABI-007 vs Dacarbazine In Previously Untreated
Patients With Metastatic Malignant Melanoma
Dr. Catalin Mihalcioiu
Abraxis
PENDING IRB APPROVAL
-McG 0935-
[H3E-EW-S124 (a)
IRB#
“Paramount”]
A Phase 3, Double-Blind, Placebo-Controlled Study of Maintenance Pemetrexed plus Best
Supportive Care versus Best Supportive Care Immediately Following Induction Treatment with
Pemetrexed + Cisplatin for Advanced Nonsquamous Non-Small Cell Lung Cancer
Dr. Vera Hirsh
PENDING IRB APPROVAL
Eli Lilly
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
-McG 0936-
[PDX101-CLN-19]
IRB#
A Multicenter, Open-Label Trial of Belonistat in Patients with Relapsed or Refractory Peripheral TCell Lymphoma
Dr. Sarit Assouline
ACTIVE
Topo Target/AAI Pharma
-McG 0937-
[THYME]
IRB#
A Phase I/II Multi-centre Study of AZD8931 in Combination with Weekly Paclitaxel to Assess the
Safety, Tolerability, Pharmacokinetics and Efficacy in Patients with Advanced Solid Tumours and in
a Selected Population with Low HER2-expressing Locally Recurrent and/or Metastatic Breast
Cancer (THYME)
Dr. Lawrence Panasci
PENDING IRB APPROVAL
Astra Zeneca
-McG 0938-
TDM4373G/BO22495
IRB#
A Phase IB/II, Open-Label Study Of The Safety, Tolerability, And Efficacy Of Trastuzumab-MCCDM1 In Combination With Pertuzumab Administered Intravenously To Patients With Her2-Positive,
Locally Advanced Or Metastatic Breast Cancer Who Have Previously Received Trastuzumab
Dr. Catalin Mihalcioiu
Genentech And Hoffman-Laroche
-McG 0939-
PR104-2002
ACTIVE
IRB#
A Randomized Phase I/II, Multi-Center, Open-Label Trial Of PR104 And Sorafenib In Patients With
Advanced Hepatocellular Carcinoma
Dr. Evgenia Garoufalis
Proacta Inc.
-McG 0940-
WITHDRAWN BY SPONSOR
CRAD001R2301
IRB# A09-M97-09B
A Randomized, Double-Blinded, Multi-Center Phase Iii Study Comparing Everolimus (RAD001)
Plus BSC Versus Placebo Plus BSC In Patients With Advanced Gastric Cancer After Progression On
Prior Systemic Chemotherapy
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
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McG Studies
Dr. Thierry Alcindor
Novartis Pharmaceuticals Canada Inc.
ACTIVATION
-McG 0941-
EMR 200038-010
IRB#
“STRIDE”
A Randomized, Double-Blind, Controlled Phase Iii Study Of Stimuvax® (L-BLP25 OR BLP25
Liposome Vaccine) In Combination With Hormonal Treatment Versus Hormonal Treatment Alone
For First-Line Therapy Of Post-Menopausal Women With Estrogen Receptor (ER)-Positive And/Or
Progesterone Receptor (PGR)-Positive, Inoperable Locally Advanced, Recurrent Or Metastatic
Breast Cancer
Dr. Wilson Miller
EMD Serono, Inc.
-McG 0942-
PENDING IRB APPROVAL
Investigator-Initiated
IRB#
A Randomized Phase I/II Study Of Vandetanib In Combination With High Dose Chemoradiation In
Patients With Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC)
Dr. Vera Hirsh with
AstraZeneca Pharmaceuticals
-McG 0943-
PENDING IRB APPROVAL
BI 1230.4
IRB#
An Open Phase I/IIA Trial To Investigate The Maximum Tolerated Dose, Safety, Pharmacokinetics,
And Efficacy Of Intravenous BI 6727 As Monotherapy Or In Combination With Subcutaneous
Cytarabine In Patients With Acute Myeloid Leukaemia
Dr. John Storring
PENDING IRB APPROVAL
Boehringer Ingelheim
-McG 0944-
20070782
IRB#
A Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Long-Term Safety And
Efficacy Of Darbepoetin Alfa Administered At 500 µg Once-Every-3-Weeks In Anemic Subjects
With Advanced Stage Non-Small Cell Lung Cancer Receiving Multi Cycle Chemotherapy
Dr. Dr. Vera Hirsh
Amgen
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
PENDING IRB APPROVAL
Revised:
2/17/2016
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McG Studies
-McG 0945-
CRAD001J2301
IRB#
A Randomized Phase III, Double-Blind, Placebo-Controlled Multicenter Trial Of Everolimus In
Combination With Trastuzumab And Paclitaxel, As First Line Therapy In Women With Her2
Positive Locally Arecurrent Dvanced Or Metastatic Breast Cancer
Dr. Wilson Miller
Novartis
-McG 0946 -
PENDING IRB APPROVAL
A4021017
IRB#
Randomized, Open Label, Phase 3 Clinical Study To Evaluate The Effect Of The Addition Of Cp751,871 To Gemcitabine And Cisplatin In Patients With Advanced Non-Small Cell Lung Cancer
Dr. Vera Hirsh
Pfizer
-McG 0947 -
PENDING IRB APPROVAL
20062004
IRB#
An Open-label, Multi-center, Phase 2 Study of Denosumab in Subjects with Giant Cell Tumor of
Bone
Dr. Thierry Alcindor
Amgen
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
PENDING IRB APPROVAL
Revised:
2/17/2016
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McG Studies
-McG 0948 -
MORAb-003-004
IRB#
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and
Safety of Weekly Farletuzumab (MORAb-003) in Combination with Carboplatin and Taxane
in Subjects with Platinum-sensitive Ovarian Cancer in First Relapse
Dr. Susie Lau
Morphotek
PENDING IRB APPROVAL
-McG 0949 –
LF-0207
IRB#
IS NOW McG 1005
Clinical Trial Name and Protocol Number (the “Clinical Trial”): FORTIS-M: A Phase 3,
randomized, double blind, placebo-controlled, study of oral talactoferrin in addition to best
supportive care in patients with non-small cell lung cancer who have failed two or more treatment
regimens.
Dr. Vera Hirsh
Agennix Inc.
PENDING IRB APPROVAL
-McG 0950 -
LUX-LUNG 3
IRB#
BI 1200.32
A Randomised, Open-Label, Phase III Study Of BIBW 2992 Versus Chemotherapy As First-Line
Treatment For Patients With Stage Iiib Or Iv Adenocarcinoma Of The Lung Harbouring An Egfr
Activating Mutation
Dr. Vera Hirsh
Boehringer Ingelheim
-McG 0951 -
PENDING IRB APPROVAL
CA180-227
IRB#
A Randomized Double-Blind Phase 3 Trial Comparing Docetaxel Combined With Dasatinib To
Docetaxel Combined With Placebo In Castration-Resistant Prostate Cancer
Dr. Wilson Miller
BMS
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
PENDING IRB APPROVAL
Revised:
2/17/2016
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McG Studies
-McG 0952 -
ABX207-GU07CA
IRB#
A Multi-Institutional Phase II Study Of Single Agent Abraxane As Second Line Therapy In
Patients With Advanced Transitional Cell Carcinoma Of The Urothelium
Dr. Adrian Langleben
Abraxis BioScience, Inc.
-McG 0953-
PENDING IRB APPROVAL
A8081005
IRB#
Phase 2, Open-Label Single Arm Study Of The Efficacy And Safety Of PF-02341066 In Patients
With Advanced Non-Small Cell Lun Cancer (NSCLC) Harboring A Translocation Or Inversion
Involving The Anaplastic Lymphoma Kinase (ALK) Gene Locus
Dr. Vera Hirsh
Pfizer Inc.
-McG 0954 -
PENDING IRB APPROVAL
A8081007
IRB#
Phase 3, Randomized, Open-Label Study Of The Efficacy And Safety Of PF-02341066 Versus
Standard Of Care Chemotherapy (Pemetrexed Or Docetaxel) In Patients With Advanced Non-Small
Cell Lung Cancer (NSCLC) Harboring A Translocation Or Inversion Event Involving Anaplastic
Lymphoma Kinase (ALK) Gene Locus
Dr. Vera Hirsh
Pfizer Inc.
-McG 1001 -
PENDING IRB APPROVAL
NO25026-ROW
IRB#
Brim 3: A multicentre, A Randomized, Double-blinded, Open-Label, Controlled, Multicenter, Phase
III Study In Previously Untreated Patients With Unresectable Stage IIIC Or Stage IV Melanoma
With V600E-Positive BRAF Mutation Receiving RO5185426 Or Dacarbazine
Dr. Wilson Miller
Hoffman-LaRoche
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
PENDING IRB APPROVAL
Revised:
2/17/2016
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McG Studies
-McG 1002 -
VGFT-ST-0708.02
IRB#
A Phase 1/2 Study Of Aflibercept Administered In Combination With Pemetrexed And Cisplatin In
Patients With Advanced Carcinoma
Dr.Carmela Pepe
Regeneron Pharmaceuticals, Inc.
-McG 1003 -
PENDING IRB APPROVAL
OXALI_L_03768
IRB#
A Multicentre, Randomized, Open-Label, Phase III Study Comparing The Efficacy Of Oral
Glutamine And Calcium-Magnesium With Calcium-Magnesium Alone In The Prevention Of
Oxaliplatin-Induced Neurotoxicity In Patients With Colorectal Cancer Treated With Oxaliplatin In
Adjuvant Or 1st Line Metastatic Settings (GLUTOX Study)
Sanofi Aventis
PENDING IRB APPROVAL
20080259
-McG 1004 -
IRB#
A PH 3, Randomized, Double-blind, Placebo-controlled Study of Pegfilgrastim Administered
to Subjects With Newly DX, Locally-advanced or Metastatic Colorectal Cancer Treated
With Bevacizumab & Either 5- fluorouracil, Oxaliplatin, Leucovorin (FOLFOX) or 5-fluorouracil,
Irinotecan, Leucovorin (FOLFIRI)
Dr. Petr Kavan
Amgen
-McG 1005 -
PENDING IRB APPROVAL
LF-0207
IRB#
Clinical Trial Name and Protocol Number (the “Clinical Trial”): FORTIS-M: A Phase 3,
randomized, double blind, placebo-controlled, study of oral talactoferrin in addition to best
supportive care in patients with non-small cell lung cancer who have failed two or more treatment
regimens.
Dr. Vera Hirsh
Agennix Inc.
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
PENDING IRB APPROVAL
Revised:
2/17/2016
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McG Studies
-McG 1006 -
20060359 (D-CARE)
IRB#
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of Denosumab as
Adjuvant Treatment for Women with Early-Stage Breast Cancer at High Risk of Recurrence
(D-CARE)
Dr. Lawrence Panasci
Amgen
-McG 1007 -
PENDING IRB APPROVAL
H8K-MC-JZAO
IRB#
A Randomized Phase 3 Study Of Tasisulam Administered As An Intravenous Infusion On Day 1 Of
A 28-Day Cycle Vs. Paclitaxel As Second-Line Treatment In Patients With Metastatic Melanoma
Dr. Catalin Mihalcioiu
Eli-Lilly Canada
-McG 1008 -
PENDING IRB APPROVAL
IMCL CP20-0801
IRB#
An Open-Label, Multicenter, Randomized Phase 2 Study Evaluating The Safety And Efficacy Of
5-FU/FA And Oxaliplatin (Modified Folfox-6) In Combination With IMC-1121B Or IMC-18F1 Or
Without Investigational Therapy As Second-Line Therapy In Patients With Metastatic Colorectal
Cancer Following Disease Progression On First-Line Irinotecan-Based Therapy
Dr. Thierry Alcindor
ImClone LLC, a subsidiary of Eli-Lilly
-McG 1009 -
CAMN107AUS17
PENDING IRB APPROVAL
IRB#
An Exploratory Trial to Assess The Improvement Of Chronic Low-Grade Non-Hematologic Adverse
Events Experienced By Patients With Philadelphia Chromosome Positive (PH+) Chronic
Myelogenous Leukemia In Chronic Phase (CML-CP) Treated With Imatinib When Switched To
Nilotinib Treatment
Dr. Pierre Laneuville
Eli-Lilly Canada
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
PENDING IRB APPROVAL
Revised:
2/17/2016
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McG Studies
-McG 1010 -
CP11-0805
IRB#
A Randomized, Multicenter, Open-Label Phase 3 Study of Pemetrexed-Cisplatin Chemotherapy Plus
IMC-11F8 Versus Pemetrexed-Cisplatin Chemotherapy Alone in the First-Line Treatment of
Patients with Nonsquamous Stage IIIb or IV Non-Small Cell Lung Cancer (NSCLC)
Dr.Vera Hirsh
ImClone LLC, a subsidiary of Eli-Lilly
-McG 1011 -
PENDING IRB APPROVAL
CP11-0806
IRB#
A Randomized, Multicenter, Open-Label, Phase 3 Study of Gemcitabine-Cisplatin Chemotherapy
Plus IMC-11F8 Versus Gemcitabine-Cisplatin Chemotherapy Alone in the First-Line Treatment of
Patients with Squamous Stage IIIb or IV Non-Small Cell Lung Cancer (NSCLC)
Dr.Vera Hirsh
ImClone LLC, a subsidiary of Eli-Lilly
-McG 1012 -
CAUY922A2202
PENDING IRB APPROVAL
IRB#
A randomized, open-label, multi-center phase II study to compare AUY922 with docetaxel or
irinotecan in adult patients with advanced gastric cancer, who have progressed after one line of
chemotherapy.
Dr. Thierry Alcindor.
Novartis
-McG 1013 -
Dr.
-McG 1014 -
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
PENDING IRB APPROVAL
IRB#
PENDING IRB APPROVAL
IRB#
Revised:
2/17/2016
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McG Studies
Dr.
PENDING IRB APPROVAL
.
Active= Open to Enrollment
Closed= Closed to Enrollment
Terminated= Study Terminated with IRB/ Information no longer required
Parentheses indicate Principal Investigator is no longer with McGill University
Revised:
2/17/2016
BL