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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-005097-31 |
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Part 1: To define the recommended dose of brivanib that can be safely administered in combination with Erbitux (Cetuximab) and irinotecan to subjects with advanced metastatic colorectal cancer (MCRC)
Part 2: To compare median duration of progression free survival (PFS)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 - Phase 1 | Active Comparator | Cetuximab + Irinotecan + Brivanib OR Cetuximab + Irinotecan + Brivanib Placebo |
|
| Arm 2 - Phase 2 | Placebo Comparator | Cetuximab + Irinotecan + Brivanib OR Cetuximab + Irinotecan + Brivanib Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetuximab | Drug | IV solution, IV, QW, 400 mg/m2 X 1, followed by 250mg/m2, until progression |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics and markers of exploratory coagulation pathways will be conducted during this trial | PK C1D1-C2-D3, biomarker throughout the study | |
| Safety and tolerability of interventions will be collected | throughout the study on Part II |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy on tumor progression and progression free survival will be collected on all enrolled subjects | throughout the study on Part II |
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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 |
|---|---|---|---|---|---|---|
| Usc/Norris Comprehensive Cancer Center Hospital | Los Angeles | California | 90033 | United States | ||
| Usc/Norris Comprehensive Cancer Center |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| D000077146 | Irinotecan |
| C509922 | brivanib |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Irinotecan | Drug | IV solution, IV, Q3W, 350 mg/m2, until progression |
|
| Brivanib | Drug | Oral, Tablet, QD, (200 mg, 400 mg, 600 mg, 800 mg dose escalation) until progression |
|
| Brivanib | Drug | Oral, Tablet, QD, MTD determined in Arm 1, Phase 1, until progression |
|
| Brivanib Placebo | Drug | Oral, tablet, QD, until progression |
|
| Los Angeles |
| California |
| 90033 |
| United States |
| James Graham Brown Cancer Center | Louisville | Kentucky | 40202 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Local Institution | Buenos Aires | Buenos Aires | C1426ANZ | Argentina |
| Local Institution | Odense C | 5000 | Denmark |
| Local Institution | Meldola Fc | 47014 | Italy |
| Local Institution | Milan | 20141 | Italy |
| Local Institution | Seoul | 135-710 | South Korea |
| Local Institution | Madrid | 28050 | Spain |
| Local Institution | Stockholm | 17176 | Sweden |
| Local Institution | Uppsala | 75185 | Sweden |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |