McGill Department Of Oncology List GBC.docx · Web viewAventis Pasteur Mérieux ConnaughtTERMINATED Dr. S. Burdette-Radoux-McG 0020-[GN301] Randomized Study of Dacarbazine Versus

Gerald Bronfman Centre for Clinical Research in OncologyClinical Research Program546 Pine Avenue WestMontreal, 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 CancerNovartis 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 L. Panasci WITHDRAWN BY COMPANY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 RelapseInex TERMINATEDDr. S. Caplan

-McG 0003- [195-301]Phase III, Randomized, Multicenter Study to Assess the Efficacy and Safety of HuM195 (Recombinant Humanized Anti-CD33 Monoclonal Antibody) in Combination with Standardized Chemotherapy Compared to Standardized Chemotherapy Alone in the Treatment of Patients With Refractory or First-Relapsed Acute Myelogenous Leukemia (AML)Theradex WITHDRAWN BY COMPANYDr. 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 CancerJanssen-OrthoDr. 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 CancerAeternaDr. 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in Lymphoma, Chronic Lymphocytic Leukemia or Multiple Myeloma Patients with Mild to Moderate AnemiaOrtho Biotech WITHDRAWN

Active= Open to Enrollment Revised: 5/7/2023Closed= Closed to EnrollmentTerminated= Study Terminated with IRB/ Information no longer required

Parentheses indicate Principal Investigator is no longer with McGill University

Page 2 of 58McG Studies

Dr. C. Shustik

-McG 0007- [M39021]An Open-Label, Randomized, Multi-Center, Phase III Trial Comparing CVP + MabThera to Standard CVP Chemotherapy in Patients with Previously Untreated CD20 Positive Follicular Lymphoma (Stage III-IV)Hoffman-LaRoche CLOSEDDr. 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 MetastasesAllos Therapeutics TERMINATEDDr. K. Sultanem

-McG 0009- [104864/552]A Phase II, Multicenter, Open-Label Study of Oral Topotecan and Cisplatin in Ovarian Cancer Recurring 6 Months Following Initial Platinum-Based ChemotherapySmithKline Beecham TERMINATED(Dr. M. Trudeau) (Dr. A. Langleben) Dr. G. Stanimir

-McG 0010- [98-6475-183]A Randomized, Open-Label, Multicenter, Phase III Study Study Comparing the Efficacy and Safety of Gemcitabine and Irenotecan HCI (CPT-11) to the Gemcitabine Alone in Patients with Locally Advanced or Metastatic Pancreatic Cancer who Have Not Received Prior Systemic TherapyPharmacia 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 CLOSEDDr. 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 ProtocolNovartis CLOSEDDr. 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 CancerEli Lilly TERMINATEDDr. L.Panasci

-McG 0013- [N91-00-02-040]A Randomized, Double-Blind, Placebo Controlled Comparison of the Analgesic Activity of Valdecoxib (SC-65872) 40mg BID as Add-on Therapy to Opioid Medication in Patients with Chronic Cancer Pain

Active= Open to Enrollment Revised: 5/7/2023 WB

Closed= Closed to EnrollmentTerminated= Study Terminated with IRB/ Information no longer required



Searle TERMINATEDDr. B. Gagnon -McG 0014- [-]Phase II Multicenter Trial with Gemcitabine and Docetaxel in Patients with Advanced (Stage IIIB + IV) Non-Small Cell Lung CancerAventis Pharma TERMINATEDDr. 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 PatientsBoehringer 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 MyelomaNeoRx CorporationDr. 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 CancerAstraZeneca TERMINATEDDr. V. Hirsh

-McG 0018- [WO16229]A Phase II Study of Herceptin Monotherapy Administered 3 Weekly in Women with HER2 Overexpression/Amplification in Metastatic Breast CancerHoffmann La-Roche TERMINATEDDr. L. Panasci

-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 MelanomaAventis Pasteur Mérieux Connaught TERMINATEDDr. 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 TERMINATEDDr. 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 TERMINATEDDr. W. Miller

-McG 0021- [PRI/EPO-INT-76/EPO-CA-489]A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Impact of Maintaining Hemoglobin Using EPREX® (Epoetin Alpha; RWJPRI-22512) in Metastatic Breast Carcinoma Subjects Receiving ChemotherapyJanssen-Ortho TERMINATEDDr. M. Thirlwell

-McG 0022- [EPO CAN 20]Randomized Trial of Epoetin Alpha in Patients with Advanced Non-Small Cell Carcinoma of the LungOCOG TERMINATEDDr. 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 FrailGlaxo Wellcome CLOSEDDr. 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 TERMINATEDDr. 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-AlphaNovartis TERMINATEDDr. 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 LeukemiaNovartis 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 LeukemiaNovartis TERMINATEDDr. C. Shustik -McG 0104- [BCH-4556-214]A Phase II Study of Troxatyl in Patients with CML Blastic Phase DiseaseBioChem Pharma, Inc.Dr. P. Laneuville COMPANY WITHDRAWN





-McG 0105- [Æ-MM-00-02]Neovastat (Æ-941) in Refractory and Early Relapse Multiple Myeloma PatientsÆterna 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 ChemotherapyEli LillyDr. 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 CervixSmithKline 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 PlatinumBristol-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 BMS-247550 Epothilone B Analog.Bristol-Myers SquibbDr. 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 SquibbDr. 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 CancerPro-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 CancerEli Lilly Dr. V. Hirsh & Dr. M. Duclos CLOSED





-McG 0111- [TH9402/II/NHL/002]Autologous TH9402 Purged Progenitor Cell transplantation for Non-Hodgkin’s LymphomaTheratechnologies 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. TERMINATEDDr. 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 MyelomaGenta TERMINATEDDr. 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 CancerRibozyme Pharmaceuticals TERMINATEDDr. W. Miller

-McG 0114ext- [RPI0102]A Phase II, Open-Label, Multicenter Trial of Angiozyme in Subjects With Metastatic Colorectal Cancer Who Have Completed RPI0003Ribozyme Pharmaceuticals TERMINATEDDr. 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 CarcinomaSanofi-Synthelabo TERMINATEDDr. W. Miller

-McG 0116- [88951A-PRT031A 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 ChemotherapyDaiichi TERMINATEDDr. M. Thirlwell

-McG 0117- [R115777-INT-17]A Phase 2 Study Evaluating the Efficacy of the Farnesyl Transferase Inhibitor (FTI) R115777 in Patients with Refractory or Elapsed Acute Myeloid Leukemia (AML)Janssen Research Fdn. TERMINATED





Dr. C. Shustik

-McG 0118- [COL14]Pilot Phase II Study of Safety and Immunogenicity of an Alvac-CEA/B7.1 Vaccine Administered Either Subcutaneously or Intranodally, Concurrently with Chemotherapy, in Patients with Metastatic Colorectal Adenocarcinoma.AventisDr. 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 TERMINATEDDr. 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 CancerPharmacia TERMINATEDDr. 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 CancerNovartis WITHDRAWNDr. M. Trudeau

-McG 0122- [PO2565]A Phase II, Open-Label Study of Interferon alfa-2b in Combination with SCH 66336 in Patients with Metastatic Renal Cell CancerSchering TERMINATEDDr. 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 CancerTAP PharmaceuticalsDr. 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 ChemotherapyHoffmann-La Roche TERMINATEDDr. V. Hirsh





-McG 0124 RG-Roche 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 RocheDr. 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 FailedAstraZeneca WITHDRAWN BY COMPANYDr. 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 CancerSugen/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 DiseasePharmacia TERMINATEDDr. M. Thirlwell

-McG 0128- [P01848]Phase II Multi-Centre Trial of Caelyx™ in Combination with Herceptin® in Her-2 Over-expressing Advanced Breast CancerSchering TERMINATEDDr. 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 OrionDr. 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 MetastasesMaxim Pharmaceuticals, Inc.Dr. S. Burdette-Radoux WITHDRAWN





-McG 0131- [Biomed 777-CLP-29]Phase III Study of Atamestane Plus Toremifene Versus Letrozole in Advanced Breast CancerBioMedicines, Inc. TERMINATEDDr. W. Miller

-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 CervixAllos Therapeutics, Inc. TERMINATEDDr. 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 MetastasisMaxim 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 DoxorubicinZarix, Inc. WITHDRAWNDr. 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 LeukemiaGenta Incorporated TERMINATEDDr. 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 CancerGlaxoSmithKline TERMINATEDDr. 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 5-FluorouracilLorus Therapeutics Inc. TERMINATEDDr. 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 TERMINATEDDr. W. Miller/Ginette-McG 0208- [P02143]A Phase II Study of Temozolomide (SCH 52365) in Subjects with Brain Metastasis from Non-Small Cell Lung CancerSchering 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 CancerAmerican Bioscience. TERMINATEDDr. 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 CancerSanofi Synthelalo/PPD DevelopmentDr. G. Shenouda/ Ginette Ricard TERMINATED

-McG 0212ext- [EFC 5512] IRB#: A00-M47-05BPhase III Randomized Trial of Concomitant Radiation, Cisplatin, and Tirapazamine (SR259075) versus Concomitant Radiation and Cisplatin in Patients with Advanced Head and Neck Cancer.Sanofi AventisDr. 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 ChemotherapyBristol Myers-SquibbDr. 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 AmgenDr. W. Miller TERMINATED





-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).BayerDr. 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.GentaDr. 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 MyelomaMillennium Pharmaceuticals/PRA InternationalDr. 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 M34101-039Millennium Pharmaceuticals/PRA InternationalDr. C. Shustik TERMINATED

-McG 0218- [2000-03]A Phase 3 Trial to Evaluate the Safety and Efficacy of Specific Immunotherapy, Recombinant Idiotype Conjugated to KLH and GM-CSF, Compared to Non-Specific Immunotherapy, KLH with GM-CSF, in Patients with Follicular Non-Hodgkin’s LymphomaGenitope CorporationDr. 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.SuperGenDr. 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





-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.LigandDr. 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.PharmacyclicsDr. 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.AmgenDr.Vera.Hirsh TERMINATED

-McG 0226- [PGT304]CT-2103 vs Gemcitabine or Vinorelbine for the Treatment of PS = 2 Patients with Chemotherapy Naïve Advance Non-Small Cell Lung Cancer (NSCLC): A Phase III Study.Cell TherapeuticsDr. 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.AllosDr. Luis Souhami TERMINATED

-McG 0228- [P02948]Phase II Trial of CAELYX® and Cyclophosphamide in Metastatic Breast Cancer.ScheringDr. L. Panasci TERMINATED





-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 PatientsAventisDr. 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.AventisDr.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.VanderbiltDr. 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.PfizerDr.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.PharmaciaDr. W.Miller TERMINATED

-McG 0302pk- [CPTAIV-0020-366]Pharmacogenics Blood Sampling Protocol for Irinotecan/ Fluorouracil/ Leucovorin (CPT-11/FU/LV).PharmaciaDr. 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 CorporationDr. C. Shustik TERMINATED





-McG 0304- [CC-5013-MM-009]A Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously TreatedSubjects with Multiple Myeloma.Celgene CorporationDr. 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 CanadaDr. 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 TERMINATEDDr. 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 CanadaDr. 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 TherapeuticsDr. 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 CanadaDr. 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 LillyDr. V. Hirsh TERMINATED





-McG 0311- [EFC4972 Xenox]A multicenter randomized double-blind placebo controlled phase III study of the efficacy of Xaliproden in reducing the neurtoxicity of the Oxaliplatin and 5-FU/LV combination in first-line treatment of patients with metastatic colorectal carcinoma (MCRC)Sanofi-SynthelaboDr. 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 RocheDr. 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.BCIRGDr. Gerald Batist TERMINATED

-McG 0314- [IMN1207-003] IRB #: A06-M48-03AIMN1207 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 CorporationDr. 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 PharmaceuticalsDr. 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 CanadaDr. Vera Hirsh TERMINATED





-McG 0319- [EDOAGL-8725-001]A Phase III, Randomized, Open-Label Study of IV Edotecarin vs. Temozolomide or Carmustine (BCNU) or Lomustine (CCNU) in Patients With Glioblastoma Multiforme That Has Progressed/Recurred After Alkylator-based (Neo)Adjuvant Chemotherapy.PharmaciaDr. 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 CanadaDr. Luis Souhami TERMINATED

-McG 0321- [ ]Use of 99Technetium-Labeled anti NRSA Fabs for Imaging in Small Cell Lung Cancer Patients.Dr. Vera Hirsh PENDING IRB SUBMISSION

-McG 0322- [C017]Promune TM (CPG 7909 Injection) in Combination with Chemotherapy in Patients with Advanced or Metastatic Non-Small Cell Lung Cancer, a Randomized, Multi-Center, Controlled, Phase 2 Study.Coley Pharmaceutical GroupDr. 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 RectumNovartisDr. Wilson Miller TERMINATED

-McG 0324-A 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 TERMINATEDDr. 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 TaxaneBristol-Meyers SquibbDr. Wilson Miller TERMINATED





-McG 0328- [M02-416]A Phase II Study Evaluating the Efficacy and Safety of ABT-751 in Patients with Renal Cell Carcinoma.AbbottDr. 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 NeckAstraZenecaDr. 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 CancerAventis CanadaDr. Vera Hirsh WITHDRAWN

-McG 0332- [P03625]A Phase II, Open-l, Study of CAELYX and Carboplatin in Platinum-Sensitive Relapsed Epithelial Ovarian Cancer.Schering CanadaDr. 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 CancerAllos TherapeuticsDr. 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.AstraZenecaDr. 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 StudyColey Pharmaceutical GroupDr. Loutfi WITHDRAWN BY COMPANY

-McG 0404- [1839IL/0551] [INFACT]A Randomized, Open-Label Phase II Study of ZD1839 (Iressa) Versus Gemcitabine and Carboplatin in Chemotherapy-Naive Patients With Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer and ECOG Performance Status 2.AstraZenecaDr. Vera Hirsh TERMINATED





-McG 0405- [MNTX302]A Double-Blind, Phase 3, Two-Week, Placebo-Controlled Study of Methylnaltrexone (MNTX) for the Relief of Constipation due to Opioid Therapy in Advanced Medical IllnessProgenics PharmaceuticalsDr. Antonio Vigano WITHDRAWN

-McG 0406- [ ] Prognostic Value of the Genetic and Biologic Determinants of Inflammation in Cancer Cachexia: A Pilot StudyMUHC RI Pilot ProjectDr. 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 TrialRocheDr. 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.GlaxoSmithKlineDr. 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 ChemotherapyAstraZenecaDr. Vera Hirsh TERMINATED

-McG 0411- [M02-447]A Phase II Study Of Abt-751 In Patients With Breast Cancer Refractory To Taxane RegimensAbbott PharmaceuticalsDr. Lawrence Panasci WITHDRAWN

-McG 0412- [BMS CA225-045]An Exploratory Pharmacogenomic Study of Cetuximab Monotherapy in Patients with Metastatic EGRF Positive Colorectal CarcinomaBristol-Meyers SquibbDr. Mark Basik TERMINATED





-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 SurgeryExelixisDr. 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 CancerBristol Myers-SquibbDr. M. Basik WITHDRAWN BY COMPANYDr. M. Trudeau

-McG 0416- [P30-302]Multicenter Randomized Comparative Phase III Trial of Onconase + Doxorubicin vs. Doxorubicin in Patients with Malignant MesotheliomaAlfacellDr. V. Hirsh DECLINED BY IRB-INVESTIGATOR WITHDRAWN

-McG 0417- [CZOL446EUS75] Z-PACTA 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 CancerNovartisDr. 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 ChemotherapyBioGenerixDr. V. Hirsh WITHDRAWN

-McG 0419-Charting the course of Arm Morbidity in Breast Cancer: A prospective, Longitudinal Follow-UpDr. A. Towers ACTIVE

-McG 0420- [XRP9881B-3001] SOPRANOA 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 TherapyAventis 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 MyelomaOrtho-BioTech





Dr. C. Shustik TERMINATED-McG 0423- [BO17704] [AVAIL]A Randomized, Double-Blind Multicenter 2-Stage Phase III Study of Bevacizumab in Combination with Cisplatin and Gemcitabine versus Placebo, Cisplatin and Gemcitabine in Patients with Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer, Who Have Not Received Prior Chemotherapy.RocheDr. Hirsh CLOSED

-McG 0423 RG- [BO17704 RG] [AVAIL]A Randomized, Double-Blind Multicenter 2-Stage Phase III Study of Bevacizumab in Combination with Cisplatin and Gemcitabine versus Placebo, Cisplatin and Gemcitabine in Patients with Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer, Who Have Not Received Prior Chemotherapy.RocheDr. 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 MesylateBMSDr. 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 MesylateBMSDr. 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 MesylateBMSDr. 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 AdenocarcinomaTom Baker Cancer CentreDr 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) NovartisDr P Laneuville TERMINATED





-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 ImatinibBMSDr. 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 BMSDr. S. Assouline TERMINATED

-McG 0502- [100554]A Phase III Randomized, Placebo-Controlled Study of Sorafenib in Patients with Advanced Hepatocellular CarcinomaBayerDr. P. Metrakos TERMINATED

-McG 0502LTF- [12311 STEP]Sorafenib Long Term Extension ProgramBayerDr. 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 BatistRoche TERMINATED

-McG 0504- [CA225100]A Randomized Multicenter phase ii study of gemcitabine/platinum/cetuximab versus gemcitabine/platinum as first-line treatment for patients with advanced/metastatic non-small cell lung cancerDr. V HirshBMS/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 PanasciNovartis 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 PanasciYM BioSciences COMPANY WITHDRAWN





-McG 0507- [3066K1-305-WW]An Open-Label, Randomized, Phase 3 Trial of Intravenous Temsirolimus (CCI-779) at Two Dose Levels Compared to Investigator’s Choice Therapy in Relapsed, Refractory Subjects with Mantle Cell Lymphoma (MCL)Dr. C ShustikWyeth 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 WeeksProtocol 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 BatistAdherex Technologies TERMINATED

-McG 0509- [Q-CTG-01-V7.0]A Multi-Center Phase II Study on Pre-Operative Administration of Gleevec in Patients with Initially Non-Resectable Gastrointestinal Stromal Tumor (gist)Dr. S MeterissianNovartis TERMINATED

-McG 0510- [BO17706 AVITA ]A Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Phase III Trial to Evaluate the Efficacy and Safety of Adding Bevacizumab (Avastin) to Gemcitabine and Erlotinib in Patients with Metastatic Pancreatic CancerDr. Richard DalfenLa 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 MelanomaDr. W MillerOnyx / 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-NaïveDr. R. RajanCell Genesys, Inc. CLOSED

-McG 0513- [HNBE-03-01]A Randomized Trial Comparing Preservation of Function Status after Either Medpulser Electroporation with Intratumoral Bleomycin Therapy or Surgery in Patients with Locally Recurrent or Second Primary Squamous Cell Carcinoma of the Anterior Oral Cavity, Soft Palate, or Tonsil That Have Failed Primary Curative TherapyDr. Shenouda Genetronics, Inc. TERMINATED





-McG 0514- [HNBE-03-02]A Randomized Trial Comparing Preservation of Function Status After Either Medpulser Electroporation with Intratumoral Bleomycin Therapy or Surgery in Patients with Locally Recurrent or Second Primary Squamous Cell Carcinoma of the Base of Tongue, Posterior Lateral Pharyngeal Wall, Hypopharynx or Larynx that Have Failed Primary Curative TherapyDr. Shenouda Genetronics, Inc. TERMINATED

-McG 0515-A Phase II Trial of Apecitabine and Gemcitabine in First-Line Treatment Of Metastatic Breast CancerDr. Lawrence PanasciGroupe 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 TractDr. Steven AdesPierre Fabre Medicament and Bristol-Myers Squibb TERMINATED

-McG 0517- [BMS CA180-034] IRB #: A00-M69-05BA 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 GambacortiBristol-Myers Squibb TERMINATED

Termination retracted: pt. stil on f/u

-McG 0518- [BMS CA180-035] IRB #: A00-M70-05BA Randomized Two-Arm Multi-Center, Open-Label Phase II Study of BMS-354825 Administered Orally at A Dose of 70 Mg Twice Daily or 140 Mg Once Daily in Subjects With Chronic Myelogenous Leukemia in Accelerated Phase, in Myeloid or Lymphoid Blast Phase or With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Imatinib Mesylate (Gleevec).Dr. Pierre LaneuvilleBristol-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 MyelomaDr. Chaim ShustikCelgene 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 CancerDr. Vera HirshHoffmann-La Roche CLOSED





- 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 CancerDr. Victor Cohen ACTIVE

-McG 0521-Clinical and Molecular Characteristics of Melanoma: A Retrospective StudyDr. 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 CarcinomaDr. Wilson MillerBayer Pharmaceuticals Corp. TERMINATED

-McG 0522LTF- [12311 STEP]Sorafenib Long Term Extension ProgramBayerDr. W. Miller ACTIVE

-McG 0523- [DOXIL-MMY-2001]A Phase II Study to Assess the Safety and Efficacy of DBD Combination Therapy (Doxil/Caelyx [Doxorubicin Hcl Liposome Injection], Velcadetm [Bortezomib] and Dexamethasone) for Previously Untreated Multiple Myeloma Patients.Dr. Chaim ShustikOrtho Biotech TERMINATED

-McG 0524- [CAMN107A2101] IRB #: A00-M85-05AA 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 MalignanciesDr. Pierre LaneuvilleNovartis CLOSED

-McG 0525- [Biomed 777-CLP-32]Open Label Treatment and Survival Continuation Study of Atmestane Plus Tormifene versus Letrozole in Advanced Breast CancerDr. Wilson MillerIntarcia Therapeutics Inc. TERMINATED

-McG 0526- [Pilot Study]Evaluation of Group Remedial Exercises for Chronic Breast Cancer related LymphedemaDr. Anna Towers & Dr. Diane St-Pierre WITHDRAWNN/A





-McG 0527- CTSU-N0147A 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 CancerDr. Thierry AlcindorNCIC 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 StorringMGI Pharma Inc. ACTIVE

-McG 0529-Prospective Study of Serum VEGF as a Predictive and Prognostic Marker of Breast Cancer Dr. Thierry Muanza WITHDRAWN

-McG 0530- [CEPO906A2303] IRB #: A00-M03-06AA 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 GotliebNovartis ACTIVE

-McG 0531- [A8501001] IRB #: A00-M97-05BInternational, 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 CancerDr. Vera HirshPfizer TERMINATED

-McG 0532- [MUH-MGH/RVH#05-092] IRB #: A09-M66-05BThe value of EGG (Electrogastrogram) in Patients with the Anorexia/Cachexia Syndrome.Dr. Martin ChasenInvestigator Initiated ACTIVE

-McG 0601 (P04601) IRB #: A00-M02-06AA 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 StudyDr. Petr KavanSchering Canada Inc. CLOSED

-McG 0602- [C05005] IRB #: A00-M11-06BA 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 CancerDr. Vera HirshMillennium Pharmaceuticals TERMINATED





-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 CancerDr. Vera HirshBMS/ImClone WITHDRAWN

-McG 0604- [STM01-102] IRB #: A01-M10-06BA Phase III, Randomized, Controlled Trial Of Myocet, Trastuzumab And Paclitaxel Versus Trastuzumab And Paclitaxel For First Line Therapy Of Metastatic Breast CancerDr. Gerald BatistSopherion Therapeutics Inc./Pharmanet CLOSED

-McG 0605- [HOG COE01] IRB #: A02-M13-06BPredicting Response And Toxicity In Patients Receiving Chemotherapy For Breast Cancer: A Multicenter Genomic, Proteomic And Pharmacogenomic Correlative StudyDr. Brian Leyland-JonesDepartment of Defense TERMINATED

-McG 0606- [ARD6123AVE-0005B/2001] IRB #: A00-M18-06AA 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 HirshSanofi 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 TherapyDr. Victor CohenImClone TERMINATED

-McG 0608- [1839IL/0225] IRB #: A02-M20-06AA 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 TumoursDr. Lawrence PanasciAstraZeneca WITHDRAWN

-McG 0609- [E7389-G000-211] IRB #: A03-M24-06BA 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 DiseaseDr. Wilson MillerEisai Medical Research, Inc. TERMINATED





-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 RobergeAmerican College of Surgeons Oncology Group (ACOSOG) WITHDRAWN

-McG 0611- [CSTI571K2301] TOPS IRB #: A04-M47-06AA 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 EndpointsDr. Pierre LaneuvilleNovartis TERMINATED

-McG 0612- [PROFIT] IRB #: A04-M48-06AA Randomized Trial Of A Shorter Radiation Fractionation Schedule For The Treatment Of Localized Prostate Cancer (Profit)Dr. Luis SouhamiOntario Clinical Oncology Group ACTIVE

-McG 0613- [AVF3694g] (BO20094) Ribbon 1 IRB #: A04-M46-06AA 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 PanasciGenentech CLOSED

-McG 0614- [D6997C00006 (9238IL/0068] [FINDER2] IRB #: A04-M53-06BA 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 TherapyDr. Lawrence PanasciAstraZeneca TERMINATED

-McG 0615- BOI IRB #: A06-M67-06ARisks and Outcomes of Mucositis in Subjects Being Treated for Breast, Colorectal, Head and Neck, Non-Small Cell Lung or Ovarian CancersDr. Luis SouhamiTriad CLOSED

-McG 0616- [20050203 (AMG 954)] IRB #: A05-M64-06BA 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 CancerDr. Richard DalfenAmgen Canada Inc. CLOSED





-McG 0617- “MARINOL” IRB #: A06-M68-06AA 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 AbnormalitiesDr. Neil MacDonaldUniversity 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 ChemotherapyDr. Vera HirshHoffmann-La Roche WITHDRAWN

-McG 0619- [CA180-033] IRB #: A06-M75-06AStudy 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 MesylateDr. Pierre LaneuvilleBristol-Myers Squibb TERMINATED

-McG 0620- DOCET_l_01799 IRB #: A12-M83-06BPhase II Study of Neoadjuvant Taxotere, Cisplatin, and 5-Fluorouracil in Patients with Gastric or Gastroesophageal Junction AdenocarcinomaDr. Steven Ades Dr Lorenzo FerriInvestigator Initiated ACTIVE

-McG 0621- [PV701.06.001] IRB #: A09-M82-06BA 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 CancerDr. Wilson MillerWellstat Bilogics Corporation. TERMINATED

-McG 0622- [EFC6125 AVE0005A/3001] IRB #: A06-M71-06AA 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 GotliebSanofi-aventis Canada Inc. CLOSED

-McG 0623- [ARD6122] IRB #: A06-M70-06AA 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 CancerDr. Susie Lausanofi-aventis Canada Inc. TERMINATED





-McG 0624- [011-007] ASCENT-2 IRB #: A09-M94-06AA Phase 3, Randomized, Open-Label Study Evaluationg DN-101 in Combination with Docetaxel in Androgen-Independent Prostate Cancer (AIPC) Dr. Wilson MillerNovacea TERMINATED

-McG 0625- [CAMN107A2109] IRB #: A09-M95-06AAn 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 PhaseDr. Pierre LaneuvilleNovartis RE-ACTIVATED

-McG 0626- [CA183-001] IRB #: A09-M96-06AA Phase II Study of Intravenous (IV) Vinflunine in Patients with Locally Advanced or Metastatic Transitional Cell (TCC) of the Urothelium (CA183001)Dr. Steven AdesBristol-Myers Squibb TERMINATED

-McG 0627- [D1532C00003] IRB #: A09-M101-06BA 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 MelanomaDr. Wilson MillerAstraZeneca TERMINATED

-McG 0628- [M05-782] IRB #: A10-M113-06BA 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 CancerDr. Catalin MihalcioiuAbbott Laboratories TERMINATED

-McG 0629- [XRP6976J/3501] IRB #: A09-M100-06BA Multicenter, Open-Label, Randomized, Phase III Trial Comparing Immediate Adjuvant Hormonal Therapy (ELIGARD-leuprolide acetate) in Combination with TAXOTERE Administered Every Three Weeks versus Hormonal Therapy Alone versus Deferred Therapy Followed by the Same Therapeutic Options in Patients at High Risk of Replapse after Radical Prostatectomy – XRP6976J/3501 TAXOTERE (docetaxel)Dr. Raghu RajanSanofi-aventis Canada Inc. TERMINATED

-McG 0630- [CC-5013-CLL-001] IRB #: A10-M108-06AA 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 LeukemiaDr. Chaim ShustikCelgene Corp. TERMINATED

-McG 0631- [P04600] IRB #: A11-M105-06AINTRON A Health Management Program IIDr. Petr Kavan





Schering Canada Inc.. PENDING ACTIVATION-McG 0632- [114-NH-301] IRB #: A10-M116-06BA 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 LymphomaDr. Chaim ShustikBiogen Idec CLOSED

-McG 0633- [20050244] IRB #: A11-M134-06BA Randomized, Double-Blind, Multicenter Study of Denosumab Compared with Zoledronic Acid (Zometa) in the Treatment of Bone Metastases in Subjects with Advanced Cancer (Excluding Breast and Prostate Cancer) or Multiple MyelomaDr. Vera HirshAmgen 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 CancerDr. Marc TischkowitzUniversity London College PENDING IRB APPROVAL

-McG 0635- [NOV-002-C301] IRB #: A11-M125-06AA 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 HirshNovelos TERMINATED

-McG 0636- [D4200C00044 “Zephyr”] IRB #: A11-M126-06AA 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 HirshAstraZeneca Canada Inc. CLOSED

-McG 0637- [MO19390] [“SAIL”] IRB #: A12-M137-06AAn 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 CancerDr. Vera HirshHoffmann-La Roche CLOSED-McG 0638- [SAT2-05-07] IRB #: A12-M138-06AA 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 TherapyDr. Vera HirshGPC Biotech Inc. TERMINATED





-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 ImatinibDr. Pierre LaneuvilleBristol-Myers Squibb WITHDRAWN

-McG 0640- [152-CL-201 LUCID] IRB #: A12-M140-06BA 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 LeukemiaDr. Chaim ShustikBiogen Idec TERMINATED

-McG 0641- [CRAD001C2240] IRB #: A12-M141-006BA 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 TherapyDr.Raghu RajanNovartis CLOSED

-McG 0701- [MK869-130] IRB #: A01-M01-07AA 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 ChemotherapyDr. Wilson MillerMerck Frosst Inc. TERMINATED

-McG 0702- [E7389-G000-305] “EMBRACE” IRB #: A01-M02-07AA 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 TaxaneDr. Wilson MillerEisai Medical Research Inc. CLOSED

-McG 0703- [A6181108] IRB #: A01-M03-07APhase 1/2 Open Label Trial of Sutent® (Sunitinib Malate) and Aromasin® (Exemestane) in the First-Line Treatment of Hormone Receptor-Positive Metastatic Breast CancerDr. Lawrence PanasciPfizer TERMINATED

-McG 0704- [EFC5505] IRB #: A01-M04-07AA 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/LVDr. Petr Kavansanofi-aventis Canada Inc. CLOSED





-McG 0705- [ELAAT] IRB #: A01-M05-07AA Randomized Comparison of Immediate versus Deferred Androgen Deprivation Therapy Using Goserelin for Recurrent Prostate Cancer after Radical Radiotherapy (ELAAT)Dr. Sergio FariaOntario Clinical Oncology Group ACTIVE

-McG 0706- [G060068] IRB #: A Randomized, Controlled Trial of TheraSphere versus Best Supportive Care for the Treatment of Advanced Hepatocellular CarcinomaDr. David ValentiMDS Nordion Therapeutics WITHDRAWN

-McG 0707- [C04-2] IRB #: A01-M11-07BA 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-M17-07AA 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 TherapyDr. Chaim Shustik Novartis Pharmaceuticals Canada Inc. TERMINATED

-McG 0709- [A6181099] IRB #: A02-M16-07AA Randomized, Phase 3 Study Of Sunitinib In Combination with Capecitabine Compared with Capecitabine in the Patients Previously Treated Breast CancerDr. Wilson Miller Pfizer Canada Inc CLOSED

-McG 0710- [] IRB #: A03-M14-07AA Phase II Open Label, Multi-Center Study with AVR118 In Anorectic Patients with Recurrent or Advanced MalignanciesDr. Martin Chasen Advanced Viral Research Corporation ACTIVE

-McG 0711- [RAPID] IRB #: A03-M21-07BA Randomized Trial of Accelerated Partial Breast Irradiation: The Canadian Rapid TrialDr. Thierry Muanza Institute for Health Research (CIHR) and the Canadian Breast Cancer Research Alliance (CBCRA ACTIVE

-McG 0712- [“ATHENA” – MO19391] IRB #: A02-M22-07BOpen-Label Study of Bevacizumab (Avastin®) Plus Taxane Monotherapy or in Combination for the First-Line Treatment of Patients with Locally Recurrent or Metastatic Breast CancerDr. Lawrence Panasci Hoffmann-La Roche CLOSED





-McG 0713- [BAY 43-9006] IRB #: A04-M35-07AA Phase IB/II Trial of Combination Of Vinorelbine with Sorafenib (Bay 43-9006) as First-Line Treatment In Patients With Metastatic Breast CancerDr. Lawrence Panasci Investigator Initiated with Bayer Canada Inc. ACTIVE

-McG 0714- [CLBH589B2202] IRB #: A03-M25-07AA 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 InhibitorsDr. Carlo Gambacorti-PasseriniNovartis Pharmaceuticals WITHDRAWN

-McG 0715- [CLBH589B2211] IRB #: A03-M26-07AA 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 InhibitorsDr. Carlo Gambacorti-PasseriniNovartis Pharmaceuticals WITHDRAWN

-McG 0716- [OZM-006] TORCH IRB #: A09-M27-07AAn 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 CancerDr. Victor CohenUniversity Health Network - Dr. Ronald Feld CLOSED

-McG 0717- [PBI-050706] IRB #: A04-M36-07AEffect of PBI-050706 in Cancer Patients Undergoing Chemotherapy and Developing Anemia First-Line Treatment in Patients with Metastatic Breast CancerDr. Michael ThirlwellPrometic Biosciences TERMINATED

-McG 0718- [CA-042] IRB #: A04-M37-07AAn Open-Label, Phase II Study of Weekly ABI-007 as First Line Therapy for Patients with Metastatic Breast CancerDr. Lawrence Panasci Abraxis BioScienceTaxane Arm Open/ Non-taxane arm Closed ON-HOLD

-McG 0719- [DOCET L 00909] IRB #: A04-M39-07BRapid and Real-Time Patient-Reported Quality of Life (QOL) Measurement Using the Prostate Cancer Symptom Scale (PSSC) in Docetaxel (Taxotere) Treated HRPC PatientsDr. Raghu RajanSanofi-Aventis TERMINATED

-McG 0720- [A6181111] IRB #: A04-M40-07BA Phase III Randomized, Double-Blind Study of Sunitib (SU011248, Sutent) versus Placebo in Patients with Progressive Advanced/Metastatic Well-Differentiated Pancreatic Islet Cell TumorsDr. Peter MetrakosPfizer ACTIVE





-McG 0721- [CAMN107AX] IRB #: A04-M41-07BA 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 LaneuvilleNovartis TERMINATED

-McG 0722- IRB #: A05-M47-07ATazarotene 0.1% Cream For the Treatment of Cutaneous T-Cell Lymphoma: A Prospective StudyDr. Irna Turchin/Dr. David Roberge ACTIVE

-McG 0723- [20050251] IRB #: A05-M48-07AA Phase 3 Randomized Trial of Chemotherapy with or without Panitumumab in Patients with Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and NeckDr. Adrian LanglebenAmgen CLOSED

-McG 0724- [BO20231B] AVEREL IRB #: A08-M49-07BA Randomized, Open-Label, Multi-Centre Study To Evaluate The Efficacy and Safety of Bevacizumab (Avastin) in Combination with Trastuzumab (Herceptin®) and Docetaxel (Taxotere®) Compared with Trastuzumab (Herceptin®) and Docetaxel (Taxotere®) Alone as First-Line Treatment for Patients with Her-2 Positive Locally Recurrent or Metastatic Breast CancerDr. Lawrence PanasciHoffmann-La Roche ACTIVE

-McG 0725- [CP043/06/FCNS] IRB #: A05-M55-07BA 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 TherapyDr. Michael ThirlwellArchimedes Development/ Research WITHDRAWN

-McG 0726- [CP045/06/FCNS] IRB #: A10-M56-07BAn 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 TherapyDr. Michael ThirlwellArchimedes Development WITHDRAWN

-McG 0727- MGCD0103-006 IRB #: A08-M57-07BA Phase I/II Study of MGCD0103 (MG-0103) in Combination with GemcitabineDr. Thierry AlcindorMethylGene Inc 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 CancerDr. Petr KavanSanofi-Aventis WITHDRAWN





-McG 0729- (AVF3693g Ribbon 2 – BO20094) IRB #: A09-M59-07AA 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 CancerDr. Lawrence PanasciGenentech TERMINATED

-McG 0730- MO19286 (Avex) IRB #: A08-M68-07BA 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 KavanHoffmann-La Roche TERMINATED

-McG 0731- MEL11 IRB #: A09-M75-07APhase II Study of a Multiantigen Therapeutic Vaccine in Patients with Metastatic Melanoma Dr. Catalin MihalcioiuSanofi-Pasteur CLOSED

-McG 0732- [EFC10547 Vanilla] IRB #: A01-M74-07AA Multinational, Randomized, Double-Blind Study, Comparing the Efficacy of Aflibercept Once Every 2 Weeks versus Placebo in Patients Treated with Gemcitabine for Metastatic Pancreatic CancerDr. Petr KavanSanofi-Aventis ON-HOLD

-McG 0733- UTSWRO.0701 IRB #: A Randomized Phase II Study of Sorafenib in Combination with High Dose Chemoradiation in Patients with Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC)Dr. Vera HirshUT Southwestern WITHDRAWN

-McG 0734- 4783-08 Symmetry IRB #: A01-M87-07AA 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 MelanomaDr. Catalin MihalcioiuSynta Pharmaceuticals CLOSED

-McG 0735- 20062080 [CONCERT1] IRB #: A10-M89-07BA Phase 2, Randomized Trial of Chemoradiation with or without Panitumumab in Subjects with Unresected, Locally Advanced Squamous Cell Carcinoma of the Head and NeckDr. Adrian LangelebenAmgen CLOSED

-McG 0736- BO20289 (BEATRICE) IRB #: A10-M90-07AAn International Multi-Centre Open-Label 2-Arm Phase III Trial of Adjuvant Bevacizumab in Triple Negative Breast CancerDr. Lawrence PanasciHoffmann-La Roche CLOSED





-McG 0737- CA180-188 IRB #: A11-M97-07ADasatinib 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 AnalysisDr. Pierre LaneuvilleBristol-Myers Squibb ACTIVE

-McG 0738- [3066K1-404-WW-105] IRB #: A03-M98-07AA 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 PatenaudeWyeth 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 CancerDr. Vera HirshGenentech CLOSED

-McG 0740- [A4061028] IRB #: A11-M105-07BA 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 CancerDr. Richard DalfenPfizer TERMINATED (never quite activated)

-McG 0741- [20060283] IRB #: All-M107-07BA Phase 2 Study of AMG 479 in Relapse or Refractory Ewing’s Family Tumours and Desmoplastic Small Round Cell TumoursDr. Petr Kavan Amgen ACTIVE

-McG 0742- [OTT 05-05 UOHI 2006-124] IRB #: A11-M110-07AA Phase 2 Randomized Study of Primary Prevention of Anthracycline-Induced Cardiotoxicity with L-Carnitine in Patients with Breast Cancer.Dr. Catalin MihalcioiuCanadian Institute of Health Research and the University of Ottawa Heart Institute CLOSED

-McG 0743- [HBS701] IRB #: A11-M109-07AA Phase 1, Multi-center, Randomized, Double-Blind, Parallel, Placebo Controlled Study of the Tolerability and Systemic Absorption of Menadione Topical Lotion as a Pre-emergent and Emergent Treatment for Epidermal-Growth-Factor-Receptor (EGFR) Inhibitor Associated RashDr. Vera HirshHana Biosciences Inc. CLOSED





-McG 0744- [D8480C00055 REGAL] IRB #: A12-M112-07AA 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 AloneDr. Petr KavanAstraZeneca ACTIVE

-McG 0745- [CRAD001C2324] IRB #: A12-M116-07BA 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-M117-07BA Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Oral Suberoylanilide Hydroxamic Acid (L-001079038, MK-0683, Vorinostat) in Patients with Advanced Malignant Pleural Mesothelioma Previously Treated with Systemic ChemotherapyDr. Vera HirshMerck Frosst ACTIVE

-McG 0747- [P05048] “INFORM” IRB #: A12-M118-07BRandomized 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) BACHDr. Lawrence PanasciSchering-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 MetrakosPfizer Canada Inc.

CLOSED

-McG 0802- [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 HirshAbraxis Bioscience Inc.

CLOSED





-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 VuongCancer Research UK & UCL Cancer Trial Centre

WITHDRAWN

-McG 0804- [P04721] IRB #: A02-M14-08A

A Fixed-Sequence, Open-Label Study to Determine the Activity of SCH 717454 as Assessed by Positron Emission Tomography in Subjects With Relapsed or Recurrent Colorectal Cancer.

Dr. Petr KavanSchering-Plough

TERMINATED

-McG 0805- [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 CancerDr. Vera HirshCelgene Corp.

TERMINATED

-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 BatistMorphotek Inc.

CLOSED

-McG 0807- [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 MetrakosProgen Pharmaceuticals

TERMINATED





-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 KavanCelldex Therapeutics Inc.

TERMINATED

-McG 0812- [3160A4-3000-WW]SKI-606

IRB #: A03-M32-08A

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 AssoulineWyeth

CLOSED

-McG 0817- [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 HirshBoehringer 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 B-Cell Chronic Lymphocytic Leukemia (B-CLL).

Dr. Pierre LaneuvilleSchering Canada Inc.

CLOSED

-McG 0819- [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 RajanCougar Biotechnology Inc.

CLOSED

-McG 0820- [MKC-103] IRB #:

A Phase 2 Study of Oral MKC-1 Administered Twice Daily for 14 Consecutive days every 4 weeks in Patients with Recurrent or resistant Epithelial Ovarian Cancer or Advanced Endometrial cancer.

Dr. Jeremy SturgeonMikana Therapeutics Inc

TERMINATED





-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 RiveraNovartis

ACTIVE

-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 AlcindorARIAD Pharmaceuticals, Inc.

ACTIVE

-McG 0824- [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 KavanPfizer Canada Inc.

TERMINATED

-McG 0825- [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 HirshMerck KgaA and EMD Serono, Inc.

TERMINATED

-McG 0826- [GEM017] IRB #: A06-M76-08A

A Phase 1 Followed by a Randomized, Phase 11 Study of Carboplatin and Etoposode with or without Obatoclax Administered every 3 weeks to Patients with Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

Dr. Vera HirshGemin X

CLOSED

-McG 0827- [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 AssoulineEli Lilly & Company

ACTIVE





-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 ResponseDr. Marc TischkowitzAstraZenecaLead PI: Dr. Andre Robidoux (Notre-Dame Hospital)

CLOSED

-McG 0830- [TLN-4601-201] MP-CHUM

A Phase II Study of TLN-4601 in Patients with Glioblastoma Multiforme

Dr. Petr KavanThallion PharmaLead PI: Karl Belanger (Notre-Dame Hospital)

TERMINATED

-McG 0831- [A6181120](AP3213-US study)

MP-CHUM-08-042

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 RajanPfizerLead PI: Dr. Fred Saad (Notre-Dame Hospital)

CLOSED

-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.VeraHirshHoffmann-La Roche

TERMINATED

-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 SouhamiInvestigator Initiated

ACTIVE





-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 ThirlwellInsys Therapeutics Inc.

CLOSED

-McG 0836- [007] 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 HirshMerck Frosst

TERMINATED

-McG 0837- [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 MillerNovartisLead PI: Dr. Denis Souliere ((Notre-Dame Hospital)

ACTIVE

-McG 0838- [Investigator-Intiated] 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 TERMINATED

-McG 0839- [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 PanasciAmgen

TERMINATED

-McG 0840- [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 AgulnikOSI Pharmaceuticals

CLOSED





-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 MillerBristol-Myers Squibb

ACTIVE

-McG 0842- [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 MilllerGlaxoSmithKline

ACTIVE

-McG 0843- [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 AloneDr. Thierry Muanza Merck KGaA

WITHDRAWN

-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.

CLOSED

-McG 0845- [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 ChemotherapyDr. Vera Hirsh Hoffmann-La Roche

TERMINATED

-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

CLOSED

-McG 0847- [CAMN 107G2301]ENEST

CHUM

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 KavanNovartisLead PI: Dr. Lucas Sideris (Hopital Maisonneuve-Rosemont)

ACTIVE at MGH, RVH and JGH

-McG 0901- [1230.5] 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 CancerDr. Vera HirshBoehringer Ingelheim

ACTIVE

-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 Anti-Leukemia Chemotherapy

Dr. Sarit AssoulineHana Bio Sciences

TERMINATED

-McG 0903- [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 StorringAmgen

ACTIVE

-McG 0904- [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 CancerDr. Walter GotliebTransitional Research in Oncology

ACTIVE





-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 GotliebTransitional Research in Oncology

CLOSED

-McG 0906- [AMR PH GL 2007 CL 001]ACT 1

IRB #: A02-M20-09A

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 HirshCelgene Corp.

TERMINATED

-McG 0907- [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 LauAriad

CLOSED

-McG 0908- [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 SchustikHoffmann-La Roche

CLOSED

-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 LaneuvilleNovartis

ACTIVE

-McG 0911- [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 MihalcioiuAbbott

CLOSED

-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 NiaziInvestigator Initiated

ACTIVE

-McG 0915- [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 StorringCelator Pharmaceuticals Inc.

TERMINATED

-McG 0916- [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 TherapyDr. Wilson MillerRoche/Genentech

CLOSED

-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 HirshPro-Acta

TERMINATED

-McG 0919- [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 AlcindorSanofi-Aventis

TERMINATED

-McG 0920- [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 StorringSeattle Genetics

APPROVAL WITHDRAWN

-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 TherapyDr. Chaim ShustikCelgene

TERMINATED

-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 SouhamiYM Biosciences

ACTIVE

-McG 0924- [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 LeukemiaDr. Pierre LaneuvilleMerck

CLOSED

-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 StorringChroma Therapeutics

ACTIVE

-McG 0928- [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 PanasciNovartis

Multicentre MechanismACTIVE

-McG 0931- [13266) IRB #: A05-M72-09B

A Phase III, Multicenter, placebo-controlled trial of Sorafenib (BAY 43-9006) in patients with relapsed or refractory





advanced predominantly non Squamous Non-Small Cell Lung CancerDr. Vera HirshBayer

ACTIVE at MGH & RVH

-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 Novartis

ACTIVE

-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) Non-Squamous NSCLCDr. Vera HirshCanBas

ACTIVE

-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 MihalcioiuAbraxis

ACTIVE

-McG 0935- [H3E-EW-S124 (a) “Paramount”] IRB #: A06-M81-09AA 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 CancerDr. Vera HirshEli Lilly

ACTIVE

-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 AssoulineTopo Target/AAI Pharma

ACTIVE

-McG 0937- [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 HER2-expressing Locally Recurrent and/or Metastatic Breast Cancer (THYME)Dr. Lawrence Panasci CLOSED





Astra Zeneca

-McG 0940- 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 AlcindorNovartis Pharmaceuticals Canada Inc.

ACTIVE

-McG 0943- BI 1230.4 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 LeukaemiaDr. John StorringBoehringer Ingelheim

ACTIVE- RVH

-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 HirshAmgen

Active at RVH and MGH

-McG 0945- 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 CancerDr. Wilson MillerNovartis

ACTIVE

-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 AlcindorAmgen

ACTIVE





-McG 0948 - 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 LauMorphotek

TERMINATED

-McG 0950 - LUX-LUNG 3BI 1200.32

IRB #: A11-M133-09B

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 HirshBoehringer Ingelheim

ACTIVE

-McG 0951 - CA180-227 IRB #: A00-M134-09BA Randomized Double-Blind Phase 3 Trial Comparing Docetaxel Combined With Dasatinib To Docetaxel Combined With Placebo In Castration-Resistant Prostate Cancer

Dr. Wilson MillerBMS

ACTIVE

-McG 0953- 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 HirshPfizer Inc.

ACTIVE

-McG 0954 - 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 HirshPfizer Inc.

ACTIVE

-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 ACTIVE





Hoffman-LaRoche

-McG 1002 - 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 PepeRegeneron Pharmaceuticals, Inc.

ACTIVE

-McG 1003 - OXALI_L_03768 IRB #: A00-M08-10A

A Multicentre, Randomized, Open-Label, Phase III Study Comparing The Efficacy Of Oral Glutamine And Calcium-Magnesium With Calcium-Magnesium Alone In The Prevention Of Oxaliplatin-Induced Neurotoxicity In Patients With Colorectal Cancer Treated With Oxaliplatin In Adjuvant Or 1st Line Metastatic Settings (GLUTOX Study)

Dr. Wilson MillerSanofi Aventis

ACTIVE

-McG 1004 - 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 KavanAmgen

ACTIVE

-McG 1005 - 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 HirshAgennix Inc.

CLOSED

-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 PENDING IRB APPROVAL




http://www.amgentrials.com/trial_details.cfm?tid=20255&cid=10&did=Cancer&local=1




Amgen

-McG 1007 - 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 MihalcioiuEli-Lilly Canada

ACTIVE

-McG 1008 - 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 AlcindorImClone LLC, a subsidiary of Eli-Lilly

ACTIVE

-McG 1009 - 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


ACTIVE

-McG 1010 - CP11-0805 IRB #: A00-M121-09BA 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

PENDING IRB APPROVAL

-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 Non-Small Cell Lung Cancer (NSCLC)

Dr.Vera HirshImClone LLC, a subsidiary of Eli-Lilly






-McG 1012 - 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

ACTIVE

-McG 1013 - 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 PENDING IRB APPROVAL

-McG 1016 - 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 MihalcioiuNovartis

ACTIVE

-McG 1017 - OXALI_L_04918 / PANCREOX IRB #: A06-M67-10AA 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 Kavansanofi-aventis Canada Inc.

ACTIVE

-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 MihalcioiuBristol-Myers Squibb


-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 MillerPfizer Inc.


-McG 1020 - 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 AlcindorZIOPHARM Oncology, Inc.


-McG 1021 - 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 MillerNovartis Pharmaceuticals Canada Inc.

ACTIVE

-McG 1022 - 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 TanguayCanadian Urologic Oncology Group (CUOG)


-McG 1023 - 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 MihalcioiuGlaxoSmithKline Biologicals


-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 StorringAmgen Inc.


-McG 1025 - 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 MihalcioiuGSK


-McG 1026 - 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. LaneuvilleARIAD


-McG 1027 - 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. HirshPfizer


-McG 1028 - 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 HirshOSI Pharmaceuticals

PENDING IRB SUBMISSION

-McG 1029 - 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 HirshBoehringer Ingelheim


-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 LauIPSEN GROUP


-McG 1031 - P05615 IRB #:





Pharmacokinetics and Safety of Oral Posaconazole (SCH56592) in Subjects at High Risk for Invasive Fungal Disease.

Dr. Gizelle PopradiSchering-Plough Canada


-McG 1032 - 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 AgulnikDaiichi

ACTIVE

-McG 1101 - 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 AlcindorDaiichi

ACTIVE

-McG 1103 - 3144A2-3004-WW CHUM

A Randomized Double-blind Placebo-Controlled Trial of Neratinib (HKI-272) After Trastuzumab in Women with Early-Stage HER2/neu Overexpressed/Amplified Breast Cancer

Dr. Wilson MillerPfizer

ACTIVE

-McG 1104 - 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 MillerHoffman-LaRoche

ACTIVE

-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 PollakJanssen

ACTIVE- JGH ONLY

-McG 1107 - 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 HirshBMS

ACTIVE- MGH ONLY

-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 TherapyDr. 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 TanguayAVEO Pharmaceuticals

PENDING APPROVAL

-McG 1110 - D0102C00004 (MINT) IRB #: A04-M40-11B


Dr. Mark BasikAstraZeneca Canada Inc

PENDING APPROVAL

-McG 1111 - CABAZ C 05331: IRB #: A05-M42-11A


Dr. Simon TanguaySanofi-Aventis

PENDING APPROVAL

-McG 1112 - IMCL CP20-0801 IRB #:


Dr. Gerald BatistQ-CROC

PENDING APPROVAL

-McG 1113 - 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 JohnsonF-Hoffmann-La Roche

PENDING APPROVAL

-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).


PENDING APPROVAL

-McG 1115 - 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 CarcinomaDr. George ShenoudaBoehringer Ingelheim

PENDING APPROVAL

-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 HirshSynta Pharma

PENDING APPROVAL

-McG 1122 - 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 therapyDr. Catalin MihalcioiuBoehringer Ingelheim

PENDING APPROVAL




Documents

McGill Department Of Oncology List GBC.docx · Web viewAventis Pasteur Mérieux ConnaughtTERMINATED Dr. S. Burdette-Radoux-McG 0020-[GN301] Randomized Study of Dacarbazine Versus