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This is a Phase I dose escalation study to determine the safety, pharmacokinetics and pharmacodynamics of BMS-582664 in patients with advanced or metastatic solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
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| 3 | Experimental |
| |
| 4 | Experimental |
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| 5 | Experimental |
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| 6 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brivanib | Drug | Tablets, Oral, 180 mg, once daily, until disease progression |
|
| 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 |
|---|---|---|
| Efficacy based on duration of response and time to progression based on assessment | measured every 8 weeks throughout the study |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Premiere Oncology | Santa Monica | California | 90404 | United States | ||
| Indiana University Med Center |
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| Brivanib | Drug | Tablets, Oral, 320 mg, once daily, until disease progression |
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| Brivanib | Drug | Tablets, Oral, 600 mg, once daily, until disease progression |
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| Brivanib | Drug | Tablets, Oral, 800 mg, once daily, until disease progression |
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| Brivanib | Drug | Tablets, Oral, 800 mg, once daily (5 days on, 2 days off), until disease progression |
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| Brivanab | Drug | Tablets, Oral, 1000 mg, once daily, until disease progression |
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| Indianapolis |
| Indiana |
| 46202 |
| United States |
| University Of Wisconsin Comprehensive Center | Madison | Wisconsin | 53792 | United States |
| Local Institution | Edmonton | Alberta | T6G 1Z2 | Canada |
| Local Institution | Ottawa | Ontario | K1H 1C4 | Canada |
| Local Institution | Milan | 20141 | Italy |
| Local Institution | Middlesex | Greater London | HA6 2RN | United Kingdom |
| Local Institution | Manchester | Greater Manchester | M20 4BX | United Kingdom |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C509922 | brivanib |
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