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The purpose of this study is to find the maximum tolerated dose of BMS-817378 in subjects with advanced cancers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-817378 | Drug | Capsule, Oral, Dose escalation to a MTD from a starting dose of 25 mg, once daily, until disease progression/subject discontinuation |
|
| Measure | Description | Time Frame |
|---|---|---|
| To establish the MTD of BMS-817378 when administered orally on a daily schedule in subjects with advanced cancers | Within the first 21 days after first dose of BMS-817378 |
| Measure | Description | Time Frame |
|---|---|---|
| Assess safety and tolerability of multiple doses of BMS-817378 administered orally on a once daily schedule in subjects with advanced or metastatic solid tumors | All time points while subject is on study | |
| Assess the safety and tolerability of co-administration of a CYP substrate cocktail and BMS-817378 given at or below the MTD (dose expansion cohort) |
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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 | Adelaide | South Australia | 5000 | Australia | ||
| Local Institution |
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| Day 22 +/-2 |
| Characterize the pharmacokinetics of BMS-817378 and its active moiety, BMS-794833 | Days 1 and 15 |
| Assess the effects of BMS-817378 and BMS-794833 on blood pressure, heart rate, ECG intervals, and left ventricular ejection fraction | All time points while subject is on study |
| Describe preliminary evidence for anti-tumor activity of BMS-817378 | Every 6 weeks |
| Nedlands |
| Western Australia |
| 6009 |
| Australia |
| Local Institution | Singapore | 169610 | Singapore |