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The purpose of this research study is to determine the highest dose of BMS-690514 that can be safely given in combination with the chemotherapeutic regimens (FOLFIRI and FOLFOX) to patients with advanced cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator |
| |
| B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-690514 / FOLFIRI | Drug | Tablets / IV, Oral / IV, up to 200 mg / irinotecan 180mg/m2, leucovorin 400 mg/m2, 5FU 400mg/m2 bolus, 2400 mg/m2 inf, once daily / q 2 weeks, up to 24 mos |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessment | throughout the study | |
| dose-limiting toxicity (DLT) | assessed for individual patients from C1D1 to C1D28 during the dose escalation portion of the protocol, until maximum tolerated dose is identified | |
| determination of maximum tolerated dose (MTD) | during dose escalation portion of the protocol. Three to six subjects are treated at a specified dose level. If deemed safe dose escalation continues until the maximum tolerated dose is identified |
| Measure | Description | Time Frame |
|---|---|---|
| Describe anti-tumor of combination therapy | Every 8 weeks throughout the study | |
| Describe effects of combination therapy on markers of therapeutic activity. e.g. blood, plasma and biopsy samples | throughtout the study |
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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 |
|---|---|---|---|---|---|---|
| University Of Alabama At Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Fox Chase Cancer Center |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C552150 | BMS-690514 |
| C410216 | Folfox protocol |
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| BMS-690514 / FOLFOX | Drug | Tablets / IV, Oral / IV, up to 200 mg / oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, 5FU 400mg/m2 bolus, 2400 mg/m2 inf, once daily / q 2 weeks, up to 24 mos |
|
| Philadelphia |
| Pennsylvania |
| 19111 |
| United States |
| Local Institution | Saint-Herblain | 44805 | France |
| Local Institution | Villejuif | 94805 | France |