Norwalk Hospital / Whittingham Cancer Center Hematology & Oncology Clinical Trials
Cancer Type
Breast
IRB #
11-23
Study Name
Study Sponsor
SWOG S1007
A Phase III Randomized Clinical Trial of Standard Adjuvant Endocrine
Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone
Receptor-Positive and HER2-Negative Breast Cancer with Recurrence
Score (RS) of 25 or Less. RxPONDER: A Clinical Trial RX for Positive
Node, Endocrine Responsive Breast Cancer
10-10
NSABP- 43
A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with
radiation Therapy and radiation Therapy alone for women with HER-2
Positive Ductal Carcinoma In situ Resected by Lumpectomy
11-17
ECOG 2108
A Randomized Phase III Trial of the Value of Early Local Therapy for the
Intact Primary Tumor in Women with Metastatic Breast Cancer
12-03
12-21
13-15
A Randomized, Two-arm, Open-label, Multicenter Phase II Trial Assessing
the Efficacy and Safety of Pertuzumab Given in Combination with
Trastuzumab plus an Aromatase Inhibitor in First Line Patients with HER2positive and Hormone Receptor-Positive Advanced (Metastatic or Locally
Advanced) Breast Cancer
A Phase III Randomized, Double Blind Placebo Controlled Study of BKM120
(PI3K inhibitor) with Fulvestrant, in Postmenopausal Women with Hormone
Receptor-Positive HER2-Negative Locally Advanced or Metastatic Breast
Cancer which Progressed on or after Aromatase Inhibitor Treatment
A Randomized, Multicenter, Double-Blind Phase 3 Study of PD-0332991
(Oral CDK 4/6 Inhibitor) plus letrozole versus placebo plus letrozole for the
Treatment of Postmenopausal Women with ER (+), HER2 (-) Breast Cancer
who have not received any prior Systemic Anti-cancer Treatment for
Advanced Disease
1
Genentech/Roche
Novartis
Pfizer
Colon
14-12
A Randomized, Double-blind, Vehicle-controlled, Parallel-group Phase 2
Study of the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of
RTA 408 Lotion in the Treatment of Patients at Risk for Radiation Dermatitis
Reata
12-14
A Phase II/III trial of Neoadjuvant FOLFOX, with Selective Use of Combined
Modality Chemoradiation versus Preoperative Combined Modality
Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing
Low Anterior Resection with Total Mesorectal Excision
Alliance N1048
10-20
A Phase III Trial of 6 vs. 12 Treatments of Adjuvant FOLFOX plus Celecoxib
or Placebo for Patients with Resected Stage III Colon Cancer
CALGB 80702
14-01
An Open-Label, Multi-Center, Randomized Phase 1B/2 Study of PF05212384 (PI3K / mTOR inhibitor) Plus 5-Luorouracil-Leucovorin-Irinotecan
(FOLFIRI) Versus Bevacizumab Plus FOLFIRI in Metastatic Colorectal
Cancer
A Phase 1, Open-label, Multi-center, Dose Escalation Study of the Safety,
Tolerability, Pharmacodynamic and Pharmacokinetic Properties of
Intravenous GC4419 in Combination with Radiation and Chemotherapy for
Squamous Cell Cancers of the Head and Neck
Pfizer
Head and Neck
13-07
Hematology
12-24
A Phase IIa, Open-Label, Multicenter Study of Single-Agent MOR00208, an
Fc-Optimized Anti-CD19 Antibody, in Patients with Relapsed or Refractory
B-Cell Non-Hodgkin’s Lymphoma
Morphosys
11-26
A Phase III Randomized Study of Oral Sapacitabine in Elderly Patients with
Newly Diagnosed Acute Myeloid Leukemia
Cyclacel
14-03
A Randomized Phase III Study of Bendamustine Plus Rituximab Versus
Ibrutinib Plus Rituximab Versus Ibrutinib Alone in Untreated Older Patients
( ≥ 65 Years of Age) with Chronic Lymphocytic Leukemia (CLL)
Alliance A041202
14-07
A phase 3b randomized study of lenalidomide (CC-5013) plus rituximab
maintenance therapy followed by lenalidomide single-agent maintenance
versus rituximab maintenance in subjects with relapsed/refractory follicular,
marginal zone or mantle cell lymphoma
Celgene
2
Galera
Pancreas
14-09
An International, Multi-Center, Double-Blind, Randomized, Phase III Trial of
90Y-Clivatuzumab Tetraxetan plus Low-Dose Gemcitabine Versus Placebo
plus Low-Dose Gemcitabine in Patients with Metastatic (Stage IV)
Pancreatic Adenocarcinoma Who Received at Least Two Prior Treatments
(PANCRIT-1)
Immunomedics
Prostate
14-05
Phase III trial of enzalutamide (NSC # 766085) versus enzalutamide,
abiraterone and prednisone for castration resistant metastatic prostate
cancer
Alliance A031201
Bladder
10-21
A Randomized Double-Blinded Phase III Study Comparing Gemcitabine,
Cisplatin and Bevacizumab to Gemcitabine, Cisplatin and Placebo in
Patients with Advanced Transitional Cell Carcinoma
CALGB 90601
Lung
12-09
Decision Impact Analysis of Foundation Medicine’s Next Generation
Sequencing Test in Advanced Non-Small Cell Lung Cancer
Foundation Medicine
14-10
A Phase II, Open Label, Single-arm Study to Assess the Safety and Efficacy
of AZD9291 in Patients with Locally Advanced/Metastatic Non Small Cell
Lung Cancer whose Disease has Progressed with Previous Epidermal
Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose
Tumours are Epidermal Growth Factor Receptor Mutation and T790M
Mutation Positive (AURA2)
AstraZeneca
Solid tumors
13-03
A Prospective Observational Study to Examine, in Routine Clinical Practice
in the US, Practice Patterns and Impact on Clinical Decision Making
Associated with the FoundationOne™ Next Generation Sequencing (NGS)
Test
Foundation Medicine
Phase 1
13-01
A Phase 1 First-in-Human Study Evaluating the Safety, Tolerability,
Pharmacokinetics and Pharmacodynamics of AMG 232 (p53 inhibitor) in
Adult Subjects with Advanced Solid Tumors
A Phase I, Open-Label, Multiple-Ascending Dose Trial to Investigate the
Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of
MSB0010718C (anti-PD-L1) in Subjects with Metastatic or Locally Advanced
Solid Tumors and Expansion to selected Indications
Amgen
14-02
3
EMD Serono
Signature (P to P)
Pending
Quorum
Modular phase II study to link targeted therapy to patients with pathway
activated tumors: Module 2 - Dovitinib for patients with tumor pathway
activations inhibited by dovitinib including tumors with mutations or
translocations of FGFR, PDGFR, VEGF, cKIT, FLT3, CSFR1, Trk and RET
Novartis
Quorum
Modular phase II study to link targeted therapy to patients with pathway
activated tumors: Module 4 – LGX818 for patients with BRAFV600 mutated
tumors
Novartis
Quorum
Modular Phase II Study to Link Targeted Therapy to Patients with Pathway
Activated Tumors: Module 1 – BKM120 for Patients with PI3K-activated
Tumors
Novartis
Quorum
Modular phase II study to link targeted therapy to patients with pathway
activated tumors: Module 3 - MEK162 for patients with RAS/RAF/MEK
activated tumors
Novartis
A Phase III, Open Label, Randomized Study of AZD9291 versus PlatinumBased Doublet Chemotherapy for Patients with Locally Advanced or
Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with
Previous Epidermal Growth Receptor Tyrosine Kinase Inhibitor Therapy and
whose Tumours harbour a T790M mutation within the Epidermal Growth
Factor Receptor Gene (AURA3)
AstraZeneca
Updated 7/10/14
4