Gerald Bronfman Centre for Clinical Research in Oncology
Clinical Research Program
546 Pine Avenue West
Montreal, Quebec H2W 1S6
- McGill Studies List Period of January 2000 to Present
-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
Dr. L. Panasci
WITHDRAWN BY COMPANY
-McG 0002[CA99002]
Pivotal Phase II Multicenter Study of Vincristine Sulfate Liposomes Injection in Diffuse Large B-Cell 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 AntiCD33 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
WITHDRAWN BY COMPANY
Dr. P. Laneuville
-McG 0004[R115777-INT-11]
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
Dr. G.Batist/Ginette Ricard
TERMINATED
-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WITHDRAWN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
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: 2/6/2016
Page 2 of 58
McG Studies
-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]
A Phase II, Multicenter, OpenFollowing Initial Platinum-Based Chemotherapy
SmithKline Beecham
(Dr. M. Trudeau) (Dr. A. Langleben) Dr. G. Stanimir
TERMINATED
-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
Searle
TERMINATED
Dr. B. Gagnon
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:
2/6/2016
WB
Page 3 of 58
McG Studies
-McG 0014[-]
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 Carboplatin versus Placebo in Combination with Paclitaxel and Carboplatin in Chemotherapy-Naïve
Patients 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 Breast Cancer
Hoffmann La-Roche
Dr. L. Panasci
TERMINATED
-McG 0019[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
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:
2/6/2016
WB
Page 4 of 58
McG Studies
-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]
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
BioChem Pharma, Inc.
Dr. P. 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
COMPANY WITHDRAWN
Revised:
2/6/2016
WB
Page 5 of 58
McG Studies
-McG 0105[Æ-MM-00-02]
Neovastat (Æ-941) in Refractory and Early Relapse Multiple Myeloma Patients
Æterna Laboratories, Inc.
Dr. C. Shustik
TERMINATED
-McG 0106[H3E-MC-JMEI(a)]
A Phase 3 Trial of ALIMTA vs Docetaxel in Patients with Locally Advanced or Metastatic Non-Small 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
(Dr. M. Trudeau) (Dr. A. Langleben) Dr. L. Souhami
TERMINATED
-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
Dr. A. Langleben
TERMINATED
-McG 0108-BC
[CA163-022]
A Protocol to Collect Blood Samples for Pharmacogenomic Research from Patients Enrolled in a Clinical Trial of BMS247550 Epothilone B Analog.
Bristol-Myers Squibb
Dr. A. Langleben
WITHDRAWN BY COMPANY
-McG 0108-TC
[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
Dr. A. Langleben
WITHDRAWN BY COMPANY
-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.
Dr. W. Miller
TERMINATED
-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
Dr. V. Hirsh & Dr. M. Duclos
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:
2/6/2016
WB
Page 6 of 58
McG Studies
-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.
Ortho Biotech Inc.
TERMINATED
Dr. V. Hirsh
-McG 0113[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
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
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:
2/6/2016
WB
Page 7 of 58
McG Studies
-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
Dr. A. Langleben
WITHDRAWN BY COMPANY
-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]
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
Dr. M. Trudeau
WITHDRAWN
-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
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:
2/6/2016
WB
Page 8 of 58
McG Studies
-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
Dr. V. Hirsh
TERMINATED
-McG 0125[0473IL/0016]
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 Paclitaxel-Based 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/5-Fluorouracil/Leucovorin Alone as First-Line Therapy
of Patients With Previously Untreated Metastatic Colorectal Cancer
Sugen/Pharmacia
WITHDRAWN BY COMPANY
Dr. A. Langleben
-McG 0127[971-ONC-0028-057]
A Pilot, Open-Label, Randomized, Comparative Study of Exemestane Versus Anastrozole in Post-Menopausal 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
Dr. W.Miller
TERMINATED
-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.
Dr. S. Burdette-Radoux
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:
2/6/2016
WB
Page 9 of 58
McG Studies
-McG 0131[Biomed 777-CLP-29]
Phase III Study of Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer
BioMedicines, Inc.
Dr. W. Miller
TERMINATED
-McG 0201[RSR13 RT-012]
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.
Dr. S. Burdette-Radoux
COMPANY WITHDRAWN
-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
-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 5Fluorouracil
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
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:
2/6/2016
WB
Page 10 of 58
McG Studies
-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.
Dr. L. Souhami
WITHDRAWN BY COMPANY
-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[]
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
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:
2/6/2016
WB
Page 11 of 58
McG Studies
-McG 0215[]
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 NonHodgkin’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
Dr. Shustik
WITHDRAWN
-McG 0220[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
Dr.N.MacDonald
WITHDRAWN BY COMPANY
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:
2/6/2016
WB
Page 12 of 58
McG Studies
-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
-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.Vera.Hirsh
TERMINATED
-McG 0226[PGT304]
CT-2103 vs Gemcitabine or Vinorelbine for the Treatment of PS = 2 Patients with Chemotherapy Naïve Advance NonSmall 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
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:
2/6/2016
WB
Page 13 of 58
McG Studies
-McG 0229[XRP6258A (RPR 116258A)/2001]
A Multicenter Phase II Randomized Study Comparing RPR 11625A Administered as a 1-HourIntravenous 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]
Pharmacogenics Blood Sampling Protocol for Irinotecan/ Fluorouracil/ Leucovorin (CPT-11/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
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:
2/6/2016
WB
Page 14 of 58
McG Studies
-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 First-line 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 5-FU/LV as First Line Therapy.
Roche Canada
TERMINATED
Dr. R. Dalfen
-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, Dose-Titration 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
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:
2/6/2016
WB
Page 15 of 58
McG Studies
-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)
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
Dr. L. Shustik
TERMINATED
-McG 0318[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
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:
2/6/2016
WB
Page 16 of 58
McG Studies
-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 NonSmall Cell Lung Cancer, a Randomized, Multi-Center, Controlled, Phase 2 Study.
Coley Pharmaceutical Group
Dr. Vera Hirsh
TERMINATED
-McG 0323[CPTK787 0133/304946]
A Randomized Double-Blind, Placebo-Controlled, Phase III Study of Oxaliplatin/5-Fluorouracil/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
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:
2/6/2016
WB
Page 17 of 58
McG Studies
-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]
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 Non-Steroidal Aromatase Inhibitor (AI) Therapy.
AstraZeneca
Dr. Lawrence Panasci
TERMINATED
-McG 0403[CO23]
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 St
Naive Patients With Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer and ECOG Performance Status 2.
AstraZeneca
Dr. Vera Hirsh
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:
-
2/6/2016
WB
Page 18 of 58
McG Studies
-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]
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 131-Tositumomab 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 Platinum-Based 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:
2/6/2016
WB
Page 19 of 58
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 0414-
MCGILL NOT PARTICIPATING
-McG 0415[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
-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
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:
2/6/2016
WB
Page 20 of 58
McG Studies
-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 NonSmall 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 NonSmall Cell Lung Cancer, Who Have Not Received Prior Chemotherapy.
Roche
Dr. Hirsh
ACTIVE
-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:
2/6/2016
WB
Page 21 of 58
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
ACTIVE
-McG 0503[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]
A Randomized Multicenter phase ii study of gemcitabine/platinum/cetuximab versus gemcitabine/platinum as firstline 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
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:
2/6/2016
WB
Page 22 of 58
McG Studies
-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:
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
Gastrointestinal Stromal Tumor (gist)
Dr. S Meterissian
Novartis
-Resectable
TERMINATED
-McG 0510[BO17706 AVITA ]
A Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Phase III Trial to Evaluate the Efficacy and Safety of
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
-McG 0513[HNBE-03-01]
A Rando
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
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:
2/6/2016
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McG Studies
-McG 0514-
[HNBE-03-02]
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
-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
Re
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
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:
2/6/2016
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McG Studies
- McG 0520BM IRB #:
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
Dr. Catalin Mialcioiu
TERMINATED
-McG 0522[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]
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
Novartis
CLOSED
-McG 0525[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
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
WITHDRAWN
Revised:
2/6/2016
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McG Studies
-McG 0527CTSU-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
WITHDRAWN
-McG 0528
[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 Dr John Storring
MGI Pharma Inc.
ACTIVE
-McG 0529Prospective Study of Serum VEGF as a Predictive and Prognostic Marker of Breast Cancer
Dr. Thierry Muanza
WITHDRAWN
-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
ACTIVE
-McG 0531[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
TERMINATED
-McG 0532[MUH-MGH/RVH#05-092]
The value of EGG (Electrogastrogram) in Patients with the Anorexia/Cachexia Syndrome.
Dr. Martin Chasen
Investigator Initiated
IRB #: A09-M66-05B
ACTIVE
-McG 0601
(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.
CLOSED
-McG 0602[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 Refractory, Locally Advanced or
Metastatic Non-Small Cell Lung Cancer
Dr. Vera Hirsh
Millennium Pharmaceuticals
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:
2/6/2016
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McG Studies
-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
BMS/ImClone
WITHDRAWN
-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
CLOSED
-McG 0605[HOG COE01]
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
TERMINATED
-McG 0606[ARD6123AVE-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 Erlotinib-Resistant, Locally Advanced or
Metastatic Non Small-Cell Lung Adenocarcinoma
Dr. Vera Hirsh
Sanofi Aventis
CLOSED
-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
Dr. Victor Cohen
ImClone
TERMINATED
-McG 0608[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
WITHDRAWN
-McG 0609[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
Eisai Medical Research, Inc.
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:
2/6/2016
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McG Studies
-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
Novartis
TERMINATED
-McG 0612[PROFIT]
IRB #: A04-M48-06A
A Randomized Trial Of A Shorter Radiation Fractionation Schedule For The Treatment Of Localized Prostate Cancer
(Profit)
Dr. Luis Souhami
Ontario Clinical Oncology Group
ACTIVE
-McG 0613[AVF3694g] (BO20094) Ribbon 1
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
Genentech
CLOSED
-McG 0614[D6997C00006 (9238IL/0068] [FINDER2]
IRB #: A04-M53-06B
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
AstraZeneca
TERMINATED
-McG 0615BOI
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
Triad
CLOSED
-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/ 5-Fluorouracil/ Leucovorin Alone in Patients with Previously
Untreated Metastatic Colorectal Cancer
Dr. Richard Dalfen
Amgen Canada 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:
2/6/2016
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McG Studies
-McG 0617“MARINOL”
IRB #: A06-M68-06A
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
CLOSED
-McG 0618[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
Hoffmann-La Roche
WITHDRAWN
-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
Bristol-Myers Squibb
TERMINATED
-McG 0620DOCET_l_01799
IRB #: A12-M83-06B
Phase II Study of Neoadjuvant Taxotere, Cisplatin, and 5-Fluorouracil in Patients with Gastric or Gastroesophageal
Junction Adenocarcinoma
Investigator Initiated
ACTIVE
-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
Wellstat Bilogics Corporation.
TERMINATED
-McG 0622[EFC6125 AVE0005A/3001]
IRB #: A06-M71-06A
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
Sanofi-aventis Canada Inc.
CLOSED
-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
sanofi-aventis Canada Inc.
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:
2/6/2016
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McG Studies
-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 AndrogenIndependent Prostate Cancer (AIPC)
Dr. Wilson Miller
Novacea
TERMINATED
-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
Novartis
RE-ACTIVATED
-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
Bristol-Myers Squibb
TERMINATED
-McG 0627[D1532C00003]
IRB #: A09-M101-06B
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
AstraZeneca
TERMINATED
-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
Abbott Laboratories
TERMINATED
-McG 0629A Multicenter, Open-
[XRP6976J/3501]
IRB #: A09-M100-06B
-
versus Deferred Therapy Followed by the Same Therapeutic Options in Patients at High Risk of Replapse after Radical
Prostatectomy –
Dr. Raghu Rajan
Sanofi-aventis Canada Inc.
TERMINATED
-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
Celgene Corp.
TERMINATED
-McG 0631[P04600]
INTRON A Health Management Program II
Dr. Petr Kavan
Schering 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
IRB #: A11-M105-06A
PENDING ACTIVATION
Revised:
2/6/2016
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McG Studies
-McG 0632[114-NH-301]
IRB #: A10-M116-06B
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
CLOSED
-McG 0633[20050244]
IRB #: A11-M134-06B
A Randomized, DoubleTreatment of Bone Metastases in Subjects with Advanced Cancer (Excluding Breast and Prostate Cancer) or Multiple
Myeloma
Dr. Vera Hirsh
Amgen Inc.
CLOSED
-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
University London College
PENDING IRB APPROVAL
-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
Novelos
TERMINATED
-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
AstraZeneca Canada Inc.
CLOSED
-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 Non-Small Cell Lung Cancer
Dr. Vera Hirsh
Hoffmann-La Roche
CLOSED
-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
GPC Biotech Inc.
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:
2/6/2016
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McG Studies
-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
Bristol-Myers Squibb
WITHDRAWN
-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
Biogen Idec
TERMINATED
-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
Novartis
CLOSED
-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
Merck Frosst Inc.
TERMINATED
-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.
CLOSED
-McG 0703[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
Pfizer
TERMINATED
-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
sanofi-aventis Canada 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:
2/6/2016
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McG Studies
-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
Ontario Clinical Oncology Group
ACTIVE
-McG 0706[G060068]
IRB #:
A Randomized, Controlled Trial of TheraSphere versus Best Supportive Care for the Treatment of Advanced
Hepatocellular Carcinoma
Dr. David Valenti
MDS Nordion Therapeutics
WITHDRAWN
-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
GERCOR/Scimega/Dream Optimox
ON-HOLD
-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
Novartis Pharmaceuticals Canada Inc.
TERMINATED
-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
Pfizer Canada Inc
CLOSED
-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
Advanced Viral Research Corporation
ACTIVE
-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 ACTIVE
-McG 0712[“ATHENA” – MO19391]
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
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:
2/6/2016
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McG Studies
-McG 0713[BAY 43-9006]
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
Investigator Initiated with Bayer Canada Inc.
ACTIVE
-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
Novartis Pharmaceuticals
WITHDRAWN
-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
Novartis Pharmaceuticals
WITHDRAWN
-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
University Health Network - Dr. Ronald Feld
CLOSED
-McG 0717[PBI-050706]
IRB #: A04-M36-07A
Effect of PBI-050706 in Cancer Patients Undergoing Chemotherapy and Developing Anemia First-Line Treatment in
Patients with Metastatic Breast Cancer
Dr. Michael Thirlwell
Prometic Biosciences
TERMINATED
-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
Dr. Lawrence Panasci
Abraxis BioScience
Taxane Arm Open/ Non-taxane arm Closed
ON-HOLD
-McG 0719[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
TERMINATED
-McG 0720[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
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:
2/6/2016
WB
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McG Studies
-McG 0721[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 0722IRB #: A05-M47-07A
Tazarotene 0.1% Cream For the Treatment of Cutaneous T-Cell Lymphoma: A Prospective Study
Dr. Irna Turchin/Dr. David Roberge
ACTIVE
-McG 0723[20050251]
IRB #: A05-M48-07A
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
CLOSED
-McG 0724[BO20231B] AVEREL
IRB #: A08-M49-07B
A Randomized, Open-Label, MultiCombination with Trastuzumab (Herceptin®) and Docetaxel (Taxotere®) Compared with Trastuzumab (Herceptin®) and
Docetaxel (Taxotere®) Alone as First-Line Treatment for Patients with Her-2 Positive Locally Recurrent or Metastatic
Breast Cancer
Dr. Lawrence Panasci
Hoffmann-La Roche
ACTIVE
-McG 0725[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
WITHDRAWN
-McG 0726[CP045/06/FCNS]
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
WITHDRAWN
-McG 0727MGCD0103-006
A Phase I/II Study of MGCD0103 (MG-0103) in Combination with Gemcitabine
Dr. Thierry Alcindor
MethylGene Inc
IRB #: A08-M57-07B
TERMINATED
-McG 0728[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
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:
2/6/2016
WB
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McG Studies
-McG 0729(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
TERMINATED
-McG 0730MO19286 (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
Hoffmann-La Roche
TERMINATED
-McG 0731MEL11
IRB #: A09-M75-07A
Phase II Study of a Multiantigen Therapeutic Vaccine in Patients with Metastatic Melanoma
Dr. Catalin Mihalcioiu
Sanofi-Pasteur
CLOSED
-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
Sanofi-Aventis
ON-HOLD
-McG 0733UTSWRO.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
WITHDRAWN
-McG 07344783-08 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
CLOSED
-McG 073520062080 [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
CLOSED
-McG 0736BO20289 (BEATRICE)
IRB #: A10-M90-07A
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
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:
2/6/2016
WB
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McG Studies
-McG 0737CA180-188
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
ACTIVE
-McG 0738[3066K1-404-WW-105]
IRB #: A03-M98-07A
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 (Now known as Pfizer)
ACTIVE
-McG 0739[APM4074g]
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
CLOSED
-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
TERMINATED
(never quite activated)
-McG 0741[20060283]
IRB #: All-M107-07B
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
ACTIVE
-McG 0742[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
CLOSED
-McG 0743[HBS701]
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-FactorReceptor (EGFR) Inhibitor Associated Rash
Dr. Vera Hirsh
Hana Biosciences 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:
2/6/2016
WB
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McG Studies
-McG 0744[D8480C00055 REGAL]
IRB #: A12-M112-07A
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
ACTIVE
-McG 0745[CRAD001C2324]
IRB #: A12-M116-07B
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
CLOSED
-McG 0746[MK-0683-014 SAHA]
IRB #: A12-M117-07B
A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Oral Suberoylanilide Hydroxamic Acid (L001079038, MK-0683, Vorinostat) in Patients with Advanced Malignant Pleural Mesothelioma Previously Treated with
Systemic Chemotherapy
Dr. Vera Hirsh
Merck Frosst
ACTIVE
-McG 0747[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.
CLOSED
-McG 0801-
[A6181114]
IRB #: A01-M03-08A
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
Pfizer Canada Inc.
-McG 0802-
CLOSED
[CA031]
IRB #: A01-M04-08A
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
Abraxis Bioscience 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:
2/6/2016
WB
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McG Studies
-McG 0803-
[]
IRB #: A00-M08-08B
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
Cancer Research UK & UCL Cancer Trial Centre
-McG 0804-
[P04721]
WITHDRAWN
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
Schering-Plough
-McG 0805-
TERMINATED
[CC-4047-SCLC-002]
IRB #: A01-M09-08B
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 #: A01-M10-08B
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
Morphotek Inc.
-McG 0807-
CLOSED
[PR88302] Pathway
IRB #: A02-M17-08A
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
Progen 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
TERMINATED
Revised:
2/6/2016
WB
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McG Studies
-McG 0811-
[CDX-110-003]
IRB #: A02-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
Celldex Therapeutics Inc.
TERMINATED
-McG 0812-
[3160A4-3000-WW]
IRB #: A03-M32-08A
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
Wyeth
-McG 0817-
CLOSED
[1200.23]
IRB #: A04-M44-08A
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
CLOSED
-McG 0818-
[P04715]
IRB #: A04-M45-08A
A Randomized Phase 2 Study of SCH 727965 in Subjects with Relapsed or refractory mantle Cell Lymphoma (MCL) or BCell Chronic Lymphocytic Leukemia (B-CLL).
Dr. Pierre Laneuville
Schering Canada Inc.
-McG 0819-
CLOSED
[COU-AA-301]
CHUM STUDY -MSSS
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
Cougar
Biotechnology Inc.
-McG 0820-
CLOSED
[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
Mikana Therapeutics 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
TERMINATED
Revised:
2/6/2016
WB
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McG Studies
-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 0823-
[AP23573-07-302]
IRB #: A05-M60-08A
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
ARIAD Pharmaceuticals, Inc.
-McG 0824-
ACTIVE
[A4021020]
IRB #: A05-M61-08A
A Phase 1/Phase 2 Study of CP-751, 871 in Patients with relapsed and/or Refractory Ewing’s Sarcoma Family of Tumors
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
Merck KgaA and EMD Serono, Inc.
-McG 0826-
TERMINATED
[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
Gemin X
-McG 0827-
CLOSED
[H6Q-MC-JCBJ]
IRB #: A06-M75-08A
PRELUDE: A Phase 3 Clinical Study to investigate the Prevention of Relapse in Lymphoma Using Daily Enzastaurin.
Dr. Sarit Assouline
Eli Lilly & Company
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:
2/6/2016
WB
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McG Studies
-McG 0828-
[D0810C00020] PARP
MP-CHUM-08.044
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)
-McG 0830-
[TLN-4601-201]
MP-CHUM
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
CLOSED
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
-McG 0833-
[]
IRB #: A11-M96-08B
High Dose Rate Brachytherapy Alone as the primary Therapy of Low Risk Endometrial Carcinoma in Elderly Women
Dr. Luis Souhami
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
ACTIVE
Revised:
2/6/2016
WB
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McG Studies
-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
Insys Therapeutics Inc.
-McG 0836-
[007]
CLOSED
IRB #: A10-M100-08A
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
Merck Frosst
-McG 0837-
TERMINATED
[CRAD001L2401]
CHUM
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
Novartis
Lead PI: Dr. Denis Souliere ((Notre-Dame Hospital)
-McG 0838-
[Investigator-Intiated]
ACTIVE
IRB #: A00-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
-McG 0839-
TERMINATED
[20060392] “STARS”
IRB #: A00-M125-08A
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-
TERMINATED
[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
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:
2/6/2016
WB
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McG Studies
-McG 0841-
[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
-McG 0842-
ACTIVE
[EGF 110656 – LOGIC- TRIO- 013]
IRB #: A11-M119-08B
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
GlaxoSmithKline
-McG 0843-
ACTIVE
[EMD 121 974-011 CENTRIC]
IRB #: N/A
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
Oncozyme Pharma Inc.
-McG 0845-
CLOSED
[NO21160]
IRB #: A00-M132-08B
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 #: N/A
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
Dr. John Storring
Johnston & Johnston Pharmaceutical
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:
2/6/2016
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McG Studies
-McG 0847-
[CAMN 107G2301]
CHUM
ENEST
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)
-McG 0901-
[1230.5]
ACTIVE at MGH, RVH and JGH
IRB #: A01-M01-09A
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 #: N/A
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 AntiLeukemia Chemotherapy
Dr. Sarit Assouline
Hana Bio Sciences
-McG 0903-
TERMINATED
[20060198]
IRB #: A03-M32-08A
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
-McG 0904-
ACTIVE
[TRIO 014]
IRB #: A01-M04-09A
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
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:
2/6/2016
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McG Studies
-McG 0905-
[TRIO 015]
IRB #: A01-M05-09A
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
CLOSED
-McG 0906-
[AMR PH GL 2007 CL 001]
IRB #: A02-M20-09A
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
Celgene Corp.
-McG 0907-
TERMINATED
[AP23573-07-205]
IRB #: A01-M21-09A
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
Ariad
-McG 0908-
CLOSED
[BO20603]
IRB #: A03-M35-09A
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)
Dr. Chaim Schustik
CLOSED
Hoffmann-La Roche
-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
Novartis
-McG 0911-
ACTIVE
[M10-440]
IRB #: A03-M38-09A
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
Abbott
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:
2/6/2016
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McG Studies
-McG 0913-
[A10-763]
IRB #: A00-M42-09B
A Phase II Study of Adjuvant/Salvage Androgen Suppression plus Radiation Therapy for High-Risk Localized
Adenocarcinoma of the Prostate
Dr. Tamin Niazi
Investigator Initiated
-McG 0915-
ACTIVE
[CLTR0308-204]
IRB #: A00-M48-09A
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
Celator Pharmaceuticals Inc.
-McG 0916-
TERMINATED
[BO21977 / TDM4370G]
IRB #: A04-M44-09B
A Randomized, Multicenter, Phase III Open-Label Study of the Efficacy and Safety of Trastuzumab-MCC-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
CLOSED
Roche/Genentech
-McG 0918-
[PR104-2003]
IRB #: A00-M47-09A
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
Pro-Acta
-McG 0919-
TERMINATED
[OXALI_L_03943]
IRB #: A00-M57-09B
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
Sanofi-Aventis
-McG 0920-
TERMINATED
[SG035-0003]
IRB #: A00-M64-09A
A pivotal study of SGN-35 in treatment of patients with relapsed or refractory Hodgkin lymphoma (HL)
Dr. John Storring
Seattle Genetics
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
APPROVAL WITHDRAWN
Revised:
2/6/2016
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McG Studies
-McG 0922-
[CC-5013-CLL-002]
IRB #: A05-M75-09B
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
TERMINATED
Celgene
-McG 0923-
[YMB1000-018]
IRB #: A12-M62-09A
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
YM Biosciences
-McG 0924-
ACTIVE
[098-02]
IRB #: A01-M21-09A
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 Chromosome Positive Chronic Myelogenous Leukemia
or Philadelphia Chromosome Positive Acute Lymphocytic Leukemia
Dr. Pierre Laneuville
CLOSED
Merck
-McG 0927-
[CHR-2797-038] (OPAL)
IRB #: A09-M98-09B
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
Chroma Therapeutics
-McG 0928-
ACTIVE
[CRAD001Y2301]
CHUM
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 0931-
Multicentre Mechanism
ACTIVE
[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
Bayer
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 at MGH & RVH
Revised:
2/6/2016
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McG Studies
-McG 0932-
[CRAD0001N2301]
IRB #: A00-M73-09B
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 First-Line Rituximab-Chemotherapy.
Dr. Laneuville
ACTIVE
Novartis
-McG 0933-
[CBP 08-02 (CANBAS)
IRB #: A05-M74-08B
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) NonSquamous NSCLC
Dr. Vera Hirsh
ACTIVE
CanBas
-McG 0934-
[CA-033 ]
IRB #: A08-M100-09B
An Open Label, Multicenter, Phase III Trial Of ABI-007 vs Dacarbazine In Previously Untreated Patients With Metastatic
Malignant Melanoma
Dr. Catalin Mihalcioiu
Abraxis
ACTIVE
-McG 0935[H3E-EW-S124 (a) “Paramount”]
IRB #: A06-M81-09A
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
ACTIVE
Eli Lilly
-McG 0936-
[PDX101-CLN-19]
IRB #: A00-M79-09A
A Multicenter, Open-Label Trial of Belonistat in Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma
Dr. Sarit Assouline
Topo Target/AAI Pharma
-McG 0937-
ACTIVE
[THYME D0102C00003]
IRB #: A00-M80-09A
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 HER2expressing Locally Recurrent and/or Metastatic Breast Cancer (THYME)
Dr. Lawrence Panasci
CLOSED
Astra Zeneca
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:
2/6/2016
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McG Studies
-McG 0938-
TDM4373G/BO22495
IRB #: A00-M96-09B
A Phase IB/II, Open-Label Study Of The Safety, Tolerability, And Efficacy Of Trastuzumab-MCC-DM1 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 0940-
ACTIVE
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
Dr. Thierry Alcindor
Novartis Pharmaceuticals Canada Inc.
-McG 0943-
BI 1230.4
ACTIVE
IRB #: A00-M104-09A
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
ACTIVE- RVH
Boehringer Ingelheim
-McG 0944-
20070782
IRB #: A12-M112-09B
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
-McG 0945-
Active at RVH and MGH
CRAD001J2301
IRB #: A00-M113-09B
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
ACTIVE
Novartis
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:
2/6/2016
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McG Studies
-McG 0947 -
20062004
IRB #: A10-M121-09B
An Open-label, Multi-center, Phase 2 Study of Denosumab in Subjects with Giant Cell Tumor of Bone
Dr. Thierry Alcindor
Amgen
-McG 0948 -
ACTIVE
MORAb-003-004
IRB #: A00-M138-09A
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
TERMINATED
-McG 0950 -
LUX-LUNG 3
IRB #: A11-M133-09B
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
ACTIVE
-McG 0951 CA180-227
IRB #: A00-M134-09B
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
-McG 0953-
ACTIVE
A8081005
IRB #: A00-M139-09A
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 -
ACTIVE
A8081007
IRB #: A03-M140-09A
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.
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:
2/6/2016
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McG Studies
-McG 1001 -
NO25026-ROW
IRB #: A01-M06-10B
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
-McG 1002 -
ACTIVE
VGFT-ST-0708.02
IRB #: A01-M07-10A
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 -
ACTIVE
OXALI_L_03768
IRB #: A00-M08-10A
A Multicentre, Randomized, Open-Label, Phase III Study Comparing The Efficacy Of Oral Glutamine And CalciumMagnesium 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)
Dr. Wilson Miller
Sanofi Aventis
-McG 1004 -
ACTIVE
20080259
IRB #: A00-M190-10A
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 -
ACTIVE
LF-0207
IRB #: A00-M11-10B
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
CLOSED
Revised:
2/6/2016
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McG Studies
-McG 1006 -
20060359 (D-CARE)
IRB #: A01-M98-10B
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 #: A00-M17-10A
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 -
ACTIVE
IMCL CP20-0801
IRB #: A09-M36-10A
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 -
ACTIVE
CAMN107AUS17
IRB #: A02-M18-10B
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
Novartis
ACTIVE
-McG 1010 CP11-0805
IRB #: A00-M121-09B
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
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:
2/6/2016
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McG Studies
-McG 1011 -
CP11-0806
IRB #: A00-M31-10B
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 NonSmall Cell Lung Cancer (NSCLC)
Dr.Vera Hirsh
ImClone LLC, a subsidiary of Eli-Lilly
-McG 1012 -
PENDING IRB APPROVAL
CAUY922A2202
IRB #: A00-M32-10B
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 -
ACTIVE
Investigator Initiated
IRB #: A00-M121-09B
Study Of the Effect of Abdominal Compressin on Respiratory Motion in Patients Planned for Hypofractionated Helical
Tomotheraphy of Abdominal or Thoracic malignancies
Dr.Jonathan Wan
-McG 1016 -
PENDING IRB APPROVAL
TBCC 905001
IRB #: A06‐M62‐10A
An Open Label Phase II Study of AntiCTLA4 (CP-675,206) in Patients with Unresectable or Metastatic Uveal Melanoma
Dr.Catalin Mihalcioiu
Novartis
ACTIVE
-McG 1017 OXALI_L_04918 / PANCREOX
IRB #: A06-M67-10A
A Randomised Phase III Study Of Capecitabine Or 5-Fluorouracil-Based Regimen With Or Without Oxaliplatin As 2nd
Line Treatment Of Advanced Or Metastatic Pancreatic Cancer In Patients Who Have Received Gemcitabine-Based
Chemotherapy.
Dr.Petr Kavan
ACTIVE
sanofi-aventis Canada Inc.
-McG 1018 -
CA184-045
IRB #: A00-M63-10A
A Multicenter Treatment Protocol For Expanded Access Use Of Ipilimumab (BMS-734016) Monotherapy In Subjects
With Unresectable Stage III Or Stage IV Melanoma
Dr.Catalin Mihalcioiu
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
PENDING IRB APPROVAL
Revised:
2/6/2016
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McG Studies
-McG 1019 -
A5481003
IRB #: A11-M82-10A
Phase 1/2, Open-Label, Randomized Study Of The Safety, Efficacy, And Pharmacokinetics Of Letrozole Plus Pd 0332991
(Oral CDK 4/6 Inhibitor) And Letrozole Single Agent For The First-Line Treatment Of ER Positive, Her2 Negative
Advanced Breast
Dr. Wilson Miller
Pfizer Inc.
-McG 1020 -
PENDING IRB APPROVAL
IPM3001 (PICASSO III)
IRB #: A09-M83-10A
A Phase III multicenter, international, randomized, double-blind, placebo-controlled study of doxorubicin plus
palifosfamide-tris vs. doxorubicin plus placebo in patients with front-line metastatic soft tissue sarcoma.
Dr.Thierry Alcindor
ZIOPHARM Oncology, Inc.
-McG 1021 -
PENDING IRB APPROVAL
CTKI258A2302
IRB #: A09-M88-10B
An open-label, randomized, multi-center, Phase III study to compare the safety and efficacy of TKI258 versus sorafenib
in patients with metastatic renal cell carcinoma after failure of anti-angiogenic (VEGF-targeted and mTOR inhibitor)
therapies
Dr. Wilson Miller
Novartis Pharmaceuticals Canada Inc.
-McG 1022 -
ACTIVE
EORTC 30073
IRB #: A10-M89-10A
Randomized Phase III trial comparing immediate versus deferred nephrectomy in patients with synchronous metastatic
renal cell carcinoma.
Dr. Simon Tanguay
Canadian Urologic Oncology Group (CUOG)
-McG 1023 -
PENDING IRB APPROVAL
DERMA 111482
IRB #: A10-M90-10A
A double-blind, randomized, placebo-controlled Phase III study to assess the efficacy of recMAGE-A3 + AS15 ASCI as
adjuvant therapy in patients with MAGE-A3 positive resected stage III melanoma
Dr.Catalin Mihalcioiu
GlaxoSmithKline Biologicals
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:
2/6/2016
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McG Studies
-McG 1024 -
20060197
IRB #: A10-M91-10A
An Open Label Extension Study Evaluating the Safety in Long Term Dosing of Romiplostim (formerly AMG 531) in
Thrombocytopenic Subjects with Myelodysplastic Syndrome (MDS)
Dr. John Storring
Amgen Inc.
-McG 1025 -
PENDING IRB APPROVAL
MEK114267
IRB #: A10-M99-10B
A Phase III randomized, open-label study comparing GSK1120212 to chemotherapy in subjects with advanced or
metastatic BRAF V600E/K mutation-positive melanoma
Dr. Catalin Mihalcioiu
GSK
-McG 1026 -
PENDING IRB APPROVAL
ARIAD: AP24534-10-201
IRB #: A11-M112-10B
A Pivotal Phase 2 Trial of Ponatinib (AP24534) in Patients with Refractory Chronic Myeloid Leukemia and Ph+ Acute
Lymphoblastic Leukemia
Dr. Laneuville
ARIAD
-McG 1027 -
PENDING IRB APPROVAL
A8081014
IRB #: A11-M108-10A
Phase 3, randomized, open label study of the efficacy and safety of Crizotinob versus Pemetrexed/cisplatin or
Pemetrexed/carboplatin in previously untreated patients with non-squamous carcinoma of the lung harbouring a
translocation or inversion event involving the anaplastic lymphoma kinase (ALK) gene locus.
Dr. Hirsh
Pfizer
-McG 1028 -
PENDING IRB APPROVAL
OSI-906-205
IRB #: A12-M116-10A
A Randomized, Double-Blind, Placebo-Controlled Phase 2study Of Maintenance OSI-906/Tarceva (Erlotinib), Or
Erlotinib/Placebo Following Non-progression Of 1st-Line Platinum-Based Chemotherapy In Patients With Advanced
NSCLC And In A Biomarker-Selected Epithelial Phenotype Subpopulation (High-E-Cadherin Protein Expression)
Dr.Vera Hirsh
OSI Pharmaceuticals
-McG 1029 -
PENDING IRB SUBMISSION
Investigator-initated
IRB #:
Neoadjuvant phase II trial with BIBW 2992 for patients with stage I, II, and III completely resected adenocarcinoma of
the lung harbouring an EGFR activating mutation
Dr.Vera Hirsh
Boehringer Ingelheim
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 SUBMISSION
Revised:
2/6/2016
WB
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McG Studies
-McG 1030 -
X-52-58064-007
IRB #: A11-M113-10B
Phase II, Open-Label, Multicenter, International Validation Study On The Use Of BN83495 In Postmenopausal Women
With Advanced, Metastatic, Or Recurrent Endometrial Carcinoma, With Estrogen Receptors (ER) Present, Who
Received A First Chemotherapy In The Adjuvant Or Metastatic Environment.
Dr. Susie Lau
IPSEN GROUP
-McG 1031 -
PENDING IRB APPROVAL
P05615
IRB #:
Pharmacokinetics and Safety of Oral Posaconazole (SCH56592) in Subjects at High Risk for Invasive Fungal Disease.
Dr. Gizelle Popradi
Schering-Plough Canada
-McG 1032 -
PENDING IRB SUBMISSION
ARQ197-A-U302
IRB #: A12-M119-10B
A phase 3, randomized, double-blinded placebo-controlled study of ARQ 197 plus Erlotinib versus placebo plus Erlotinib
in previously treated subjects with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC)
Dr. Jason Agulnik
Daiichi
-McG 1101 -
ACTIVE
EZN-2208-04
IRB #: A01-M10-11B
A Phase 2 Study of EZN-2208 (PEG-SN38) Administered With or Without Cetuximab in Patients with Metastatic
Colorectal Carcinoma (mCRC)
Dr. Thierry Alcindor
Daiichi
-McG 1103 -
ACTIVE
3144A2-3004-WW
CHUM
A Randomized Double-blind Placebo-Controlled Trial of Neratinib (HKI-272) After Trastuzumab in Women with EarlyStage HER2/neu Overexpressed/Amplified Breast Cancer
Dr. Wilson Miller
Pfizer
-McG 1104 -
ACTIVE
CTRN 209714
IRB #: A02-M14-11B
A Phase 2 Study of EZN-2208 (PEG-SN38) Administered With or Without Cetuximab in Patients with Metastatic
Colorectal Carcinoma (mCRC)
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
ACTIVE
Revised:
2/6/2016
WB
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McG Studies
-McG 1105 -
212082-PCR-3001
IRB #: A02-M23-11B
An Open Label Study of Abiraterone Acetate in Subjects with Metastatic Castration-Resistant Prostate Cancer Who
Have Progressed After Taxane-Based Chemotherapy
Dr. Michael Pollak
Janssen
-McG 1107 -
ACTIVE- JGH ONLY
CA184104
IRB #: A03-M31-11B
Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab in Addition to Paclitaxel
and Carboplatin versus Placebo in Addition to Paclitaxel and Carboplatin in Subjects with Stage IV/Recurrent Non-Small
Cell Lung Cancer (NSCLC)
Dr. Vera Hirsh
ACTIVE- MGH ONLY
BMS
-McG 1108 -
IMCL CP20-0801
IRB #: A04-M38-11B
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
PENDING APPROVAL
-McG 1109 -
AV-951-10-202
IRB #: A04-M39-11B
Prospective Study to Identify Molecular Mechanisms of Clinical Resistance to Standard First-Line Therapy in Patients
with Metastatic Colorectal Cancer (Protocol Q- CROC-01)
Dr. Simon Tanguay
AVEO Pharmaceuticals
-McG 1110 -
PENDING APPROVAL
D0102C00004 (MINT)
IRB #: A04-M40-11B
Prospective Study to Identify Molecular Mechanisms of Clinical Resistance to Standard First-Line Therapy in Patients
with Metastatic Colorectal Cancer (Protocol Q- CROC-01)
Dr. Mark Basik
AstraZeneca Canada Inc
-McG 1111 -
PENDING APPROVAL
CABAZ C 05331:
IRB #: A05-M42-11A
Prospective Study to Identify Molecular Mechanisms of Clinical Resistance to Standard First-Line Therapy in Patients
with Metastatic Colorectal Cancer (Protocol Q- CROC-01)
Dr. Simon Tanguay
Sanofi-Aventis
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 APPROVAL
Revised:
2/6/2016
WB
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McG Studies
-McG 1112 -
IMCL CP20-0801
IRB #:
Prospective Study to Identify Molecular Mechanisms of Clinical Resistance to Standard First-Line Therapy in Patients
with Metastatic Colorectal Cancer (Protocol Q- CROC-01)
Dr. Gerald Batist
Q-CROC
-McG 1113 -
PENDING APPROVAL
BO21005
IRB #: A05-M42-11A
A Phase III, Multicenter, Open-Label, Randomized Trial Comparing The Efficacy Of Ga101 (Ro5072759) In Combination
With Chop (G-Chop) Versus Rituximab And Chop (R-Chop) In Previously Untreated Patients With CD20-Positive Diffuse
Large B-Cell Lymphoma (DLBCL).
Dr. Nathalie Johnson
PENDING APPROVAL
F-Hoffmann-La Roche
-McG 1114 -
CAMN107E2401
IRB #: A05-M42-11A
Extending molecular responses with Nilotinib in newly diagnosed chronic myeloid leukemia (CML) patients in chronic
phase (ENEST xtnd).
Dr. Pierre Laneuville
Novartis
-McG 1115 -
PENDING APPROVAL
1200.131
IRB #: A06-M61-11A
Lux-Head & Neck 2: A Randomised, Double-Blind, Placebo-Controlled, Phase III Study To Evaluate The Efficacy And
Safety Of Afatinib (BIBW 2992) As Adjuvant Therapy After Chemo-Radiotherapy In Primary Unresected Patients With
Stage III, IVA, or IVB Loco-Regionally Advanced Head And Neck Squamous Cell Carcinoma
Dr. George Shenouda
PENDING APPROVAL
Boehringer Ingelheim
-McG 1116 -
9090-08
IRB #: A05-M42-11A
A Randomized, Phase IIB/III Study of Ganetespib (STA-9090) in Combination with Docetaxel versus Docetaxel alone in
Subjects with Stage IIIB or IV Non-Small Cell Lung Cancer.
Dr. Vera Hirsh
Synta Pharma
-McG 1122 -
PENDING APPROVAL
1200.67
IRB #: A09-M92-11A
Randomised phase II study of Afatinib alone or in combination with Vinorelbine versus investigator’s choice of
treatment in patients with HER2-positive breast cancer with progressive brain metastases after Trastuzumab or
Lapatinib based therapy
Dr. Catalin Mihalcioiu
PENDING APPROVAL
Boehringer Ingelheim
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:
2/6/2016
WB