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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT# 2008-007768-41 |
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The purpose of this study is to determine the efficacy of CT-322 comparative to bevacizumab, both in combination with carboplatin and paclitaxel in the treatment of chemonaive subjects with recurrent or advanced non-squamous NSCLC
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel/Carboplatin/CT-322 | Active Comparator |
| |
| Paclitaxel/Carboplatin/Bevacizumab/Placebo | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel | Drug | Solution, IV, 200 mg/m2, Q21days, 6 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival based on tumor assessments (CT scans/MRI) | every 6 weeks until documented progressive disease , death or initiation of subsequent therapy for NSCLC |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) between 2 arms | every 12 weeks | |
| Objective tumor response rate (ORR) between 2 arms | every 6 weeks | |
| Safety in the CT-322 plus carboplatin and paclitaxel arm |
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For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Acrc/Arizona Clinical Research Center, Inc. | Tucson | Arizona | 85715 | United States | ||
| Sharp Clinical Oncology Research |
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| Carboplatin | Drug | Solution, IV, AUC=6, Q21days, 6 cycles |
|
|
| CT-322 | Drug | Solution, IV, 2 mg/kg, Q7days, Until PD |
|
|
| Bevacizumab | Drug | Solution, IV, 15 mg/kg, Q21days, Until PD |
|
|
| Bevacizumab placebo (ie saline solution) | Drug | Solution, IV, 0 mg/kg, On days 8 and 15 of a 3-weekly cycle, Until PD |
|
|
| weekly |
| San Diego |
| California |
| 92123 |
| United States |
| Cancer Institute Of Florida | Orlando | Florida | 32804 | United States |
| Palm Beach Cancer Institute | West Palm Beach | Florida | 33401 | United States |
| Clintell, Inc. | Skokie | Illinois | 60077 | United States |
| Cancer Center Of Kansas | Wichita | Kansas | 67214 | United States |
| Kentucky Cancer Clinic | Hazard | Kentucky | 41701 | United States |
| Annapolis Oncology Center | Annapolis | Maryland | 21401 | United States |
| Meritus Center For Clinical Research | Hagerstown | Maryland | 21740 | United States |
| North Mississippi Hematology And Oncology Associates, Ltd | Tupelo | Mississippi | 38801 | United States |
| Piedmont Hematology Oncology Associates, Pllc | Winston-Salem | North Carolina | 27103 | United States |
| North Canton Medical Clinic Center | Canton | Ohio | 44710 | United States |
| Kaiser Permanente Oncology/Hematology | Portland | Oregon | 97227 | United States |
| Guthrie Clinic, Ltd | Sayre | Pennsylvania | 18840 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Charleston Hematology Oncology Associates, Pa | Charleston | South Carolina | 29414 | United States |
| Cancer Center At Cookeville Regional Medical Center | Cookeville | Tennessee | 38501 | United States |
| University Of Tennessee Cancer Institute | Memphis | Tennessee | 38104 | United States |
| Blue Ridge Cancer Care | Christiansburg | Virginia | 24073 | United States |
| Providence Western Washington Oncology | Lacey | Washington | 98503 | United States |
| Local Institution | Fortaleza | Ceará | 60336550 | Brazil |
| Local Institution | Belo Horizonte | Minas Gerais | 30130-100 | Brazil |
| Local Institution | Rio de Janeiro | Rio de Janeiro | 20231-050 | Brazil |
| Local Institution | Porto Alegre | Rio Grande do Sul | 90050-170 | Brazil |
| Local Institution | Barretos | São Paulo | 14784-400 | Brazil |
| Local Institution | São Paulo | São Paulo | 04024-002 | Brazil |
| Local Institution | São Paulo | São Paulo | 05403-000 | Brazil |
| Local Institution | Marseille | 13915 | France |
| Local Institution | Paris | 75005 | France |
| Local Institution | Rennes | 35033 | France |
| Local Institution | Toulouse | 31059 | France |
| Local Institution | Tours | 37044 | France |
| Local Institution | Meldola (Fc) | 47014 | Italy |
| Local Institution | Ravenna | 48100 | Italy |
| Local Institution | Rimini | 47900 | Italy |
| Local Institution | Roma | 00189 | Italy |
| Local Institution | Terni | 05100 | Italy |
| Local Institution | Bialystok | 15-540 | Poland |
| Local Institution | Gdansk | 80952 | Poland |
| Local Institution | Otwock | 05-400 | Poland |
| Local Institution | Poznan | 60 569 | Poland |
| Local Institution | Szczecin | 70-891 | Poland |
| Local Institution | Warsaw | 02-781 | Poland |
| Local Institution | Chelyabinsk | 454087 | Russia |
| Local institution | Ivanovo | 153013 | Russia |
| Local Institution | Moscow | 115 478 | Russia |
| Local Institution | Moscow | 115478 | Russia |
| Local Institution | Moscow | 143423 | Russia |
| Local Institution | Port Elizabeth | Eastern Cape | 6045 | South Africa |
| Local Institution | Pretoria | Gauteng | 0002 | South Africa |
| Local Institution | Cape Town | Western Cape | 7570 | South Africa |
| Local Institution | Cape Town | Western Cape | 7925 | South Africa |
| Local Institution | Rondebosch | Western Cape | 7700 | South Africa |
| Local Institution | Manchester | Greater Manchester | M23 9LT | United Kingdom |
| Local Institution | Leeds | West Yorkshire | LS9 7TF | United Kingdom |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| C549678 | CT-322 |
| D000068258 | Bevacizumab |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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