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Part A: The purpose of this study is to find the maximum tolerated dose of BMS-777607 in subjects with advanced or metastatic solid tumors
Part B: The purpose of this study is to describe the preliminary activity of BMS-77607 in subjects with advanced or metastatic gastroesophageal cancer, hormone refractory prostate cancer, head and neck squamous cell carcinoma, and type I papillary renal cell carcinoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-777607 | Drug | Suspension/Tablet, Oral, Dose escalation to an MTD from a starting dose of 10 mg, once daily, until disease progression/subject discontinuation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and efficacy assessment including vitals signs, physical assessments, and blood tests | will be conducted weekly for the first 3 weeks then every 3 weeks. All assessments will continue for at least 24 months | |
| Tumor assessments | will be conducted every 6 weeks. All assessments will continue for at least 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) of BMS-777607 and its N-oxide metabolite, BMS-797669 | will be assessed once weekly for the first 3 weeks | |
| The effects of BMS-777607 on blood pressure (BP), heart rate (HR) | will be assessed once weekly for the first 3 weeks then every 3 weeks |
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Inclusion Criteria:
Part A:
Part B:
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 | Camperdown | New South Wales | 2050 | Australia | ||
| Local Institution |
| ID | Term |
|---|---|
| C550356 | N-(4-(2-amino-3-chloropyridin-4-yloxy)-3-fluorophenyl)-4-ethoxy-1-(4-fluorophenyl)-2-oxo-1,2-dihydropyridine-3-carboxamide |
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| Effects on electrocardiogram (ECG), PR interval | will be assessed at base line, at week 3 and at end of treatment |
| Effects on left ventricular function | will be assessed at baseline and every 3 weeks for 1st 6 weeks then once every 6 months |
| Kogarah |
| New South Wales |
| 2217 |
| Australia |