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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT # 2008-006561-89 |
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The purpose of this study is to determine the efficacy of CT-322 comparative to bevacizumab, both in combination with irinotecan, 5-FU and leucovorin in the second-line treatment of subject with metastatic colorectal cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator | Irinotecan/5-Fluorouracil (bolus)/5-Fluorouracil (infusional)/Leucovorin calcium/CT-322 |
|
| Arm 2 | Active Comparator | Irinotecan/5-Fluorouracil(bolus)/5-Fluorouracil(infusional)/Leucovorin calcium /Bevacizumab/Bevacizumab Placebo(saline solution) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irinotecan | Drug | Solution, IV, 180 mg/m2, Q14 days, Until PD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival based on tumor assessments (CT/MRI) | Every 6 weeks until documented progressive disease, initiation fo subsequent therapy for colorectal cancer, or withdrawal of consent |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS), defined as the time the subject is randomized until death, in each arm | every 12 weeks | |
| Objective tumor response rate (ORR), defined as the proportion of randomized subjects in each arm whose best response is CR (complete response) or PR (partial response) using RECIST guidelines as determined by the site investigator |
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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 | ||
| Compassionate Cancer Care Medical Group Inc |
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| 5-Fluorouracil (bolus) | Drug | Solution, IV, 400 mg/m2, Q14 days, Until PD |
|
| 5-Fluorouracil (infusional) | Drug | Solution, IV, 2400 mg/m2, Q14 days, Until PD |
|
| Leucovorin calcium | Drug | Solution, IV, 400 mg/m2, Q14 days, Until PD |
|
| CT-322 | Drug | Solution, IV, 2 mg/kg, Q7 days, Until PD |
|
|
| Bevacizumab | Drug | Solutions, IV, 5 mg/kg, Q14 days, Until PD |
|
|
| Bevacizumab Placebo (saline solution) | Drug | Solution, IV, 0 mg/kg, On day 8 of a 2-week cycle, Until PD |
|
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| every 6 weeks |
| Safety in the CT-322 plus irinotecan, 5-FU and leucovorin arm as measured by incidence of serious and non-serious adverse events, significant laboratory evaluations and significant physical examination findings in subjects | weekly |
| Fountain Valley |
| California |
| 92708 |
| United States |
| Compassionate Cancer Care Medical Group, Inc | Riverside | California | 92501 | United States |
| Sharp Memorial Hospital | San Diego | California | 92123 | United States |
| Florida Cancer Specialists | Fort Myers | Florida | 33916 | United States |
| Midwest Center For Hematology/Oncology | Joliet | Illinois | 60432 | United States |
| Cancer Center Of Kansas | Wichita | Kansas | 67214 | United States |
| Gurtler, Jayne | Metairie | Louisiana | 70006 | United States |
| Guthrie Clinic, Ltd | Sayre | Pennsylvania | 18840 | United States |
| Pharma Resource | East Providence | Rhode Island | 02915 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| University Of Texas M.D. Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Local Institution | BahÃa Blanca | Buenos Aires | 8000 | Argentina |
| Local Institution | Capital Federal | Buenos Aires | 1426 | Argentina |
| Local Institution | Terni | 05100 | Italy |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D000077146 | Irinotecan |
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| C549678 | CT-322 |
| D000068258 | Bevacizumab |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| 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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