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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-016699-63 | EudraCT Number |
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The purpose of this study is to determine a safe and maximum tolerable dose of Brivanib when combined with standard dose 5FU/LV and FOLFIRI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Experimental |
| |
| Arm 3 | Experimental | Japanese Population |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5-FU | Drug | IV solution, IV bolus over 2-4 minutes, 400 mg/m², Every 14 days, Until disease progression/toxicity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety-Toxicity, evaluated according to NCI Common Terminology Criteria for Adverse Events v3.0. Assessments based on medical review of adverse events, results of vital signs, ECGs, echocardiography, physical examinations, and clinical laboratory tests | Cycle 4, Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (Cmax, Tmax, AUC (TAU), T-HALF) plasma concentration vs time for brivanib given alone and in combination with FOLFIRI. Individual concentrations (C) of 5FU will be calculated from samples on Day 2 in the presence and absence of Brivanib | Cycle 2, Day 2 | |
| Efficacy-Tumor BOR determined for treated subjects by radiological responses assessed by CT scan or MRI, by RECIST criteria (v1.1). Radiological tumor assessments to evaluate response & progression will be done every 8 wks or more frequently if indicated |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
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 | Los Angeles | California | 90033 | United States | ||
| Texas Oncology |
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| Leucovorin | Drug | IV solution, IV over 2 hours, 400 mg/m², Every 14 days, Until disease progression/toxicity |
|
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| 5-FU | Drug | IV solution, IV infusion over 46 hours, 2400 mg/m², Every 14 days, Until disease progression/toxicity |
|
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| Irinotecan | Drug | IV solution, IV over 90 minutes, 180 mg/m², Every 14 days, Until disease progression/toxicity |
|
|
| Brivanib | Drug | Tablets, Oral, 400 - 800 mg, once daily, Until disease progression/toxicity |
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| Brivanib | Drug | Tablets, Oral, 600 - 800 mg, once daily, Until disease progression/toxicity |
|
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| Brivanib | Drug | Tablets, Oral, 800 mg, once daily, Until disease progression/toxicity |
|
|
| Every 8 weeks |
| Exploratory Measures (Biomarkers for Predictive Analysis): Potential predictive markers, including activity of FGF, VEGF and related pathways as well as K-RAS mutation status, will be evaluated based on blood or tumor samples | Cycle 1, Cycle 2, every other cycle |
| Dallas |
| Texas |
| 75246 |
| United States |
| Scott & White Memorial Hospital And Clinic | Temple | Texas | 76508 | United States |
| Local Institution | Edmonton | Alberta | T6G 1Z2 | Canada |
| Local Institution | Ottawa | Ontario | K1H 8L6 | Canada |
| Local Institution | Villejuif | 94800 | France |
| ID | Term |
|---|---|
| D046248 | Pyloric Stenosis, Hypertrophic |
| ID | Term |
|---|---|
| D011707 | Pyloric Stenosis |
| D017219 | Gastric Outlet Obstruction |
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| D000077146 | Irinotecan |
| C509922 | brivanib |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| 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 |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
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