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The purpose of this clinical study is to establish the maximum tolerated dose of BMS-754807 when administered orally on a once daily schedule in subjects with solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-754807 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-754807 | Drug | Tablets, Oral, 20 mg, 30 mg, 50 mg, 70 mg, 100 mg, 130 mg, 160 mg, 200 mg once daily, 3-5 months, depending on response |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the Maximum Tolerated Dose of BMS-754807 based on the Dose Limited Toxicity which observed during the first 28 days | Within the first 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability | Day 1, 8, 15, 22, 29, thereafter every 2 weeks | |
| To establish recommended Phase 2 dose of BMS-754807 when administered orally on a once daily schedule | Day 1, 8, 15, 22, 29, thereafter every 2 weeks |
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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 |
|---|---|---|---|---|---|---|
| Local Institution | Chuo-Ku | Tokyo | 104-0045 | Japan |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C545990 | BMS 754807 |
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| To assess the metabolic effect on blood glucose | Day 1, 8, 15, 22, 29, thereafter every 2 weeks |
| To assess the pharmacokinetics of BMS-754807 administered orally on a once daily schedule | Day 1, 8, 15, 22, 29, thereafter every 2 weeks |
| To assess any preliminary evidence of anti-tumor activity | Day 1, 8, 15, 22, 29, thereafter every 2 weeks |
| To explore potential biomarkers of biological response | Day 1, 8, 15, 22, 29, thereafter every 2 weeks |