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The purpose of this clinical study is to establish the maximum tolerated dose (MTD) and recommended Phase 2 dose (or dose range as appropriate) of BMS-907351 (XL184) when administered orally on a once daily schedule in subjects with advanced or metastatic solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-907351 (XL184) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-907351 (XL184) | Drug | Capsules, Oral, 25, 50, 75, 100, 125 and 175 mg, Once daily, Until disease progression or unacceptable toxicity became apparent |
|
| Measure | Description | Time Frame |
|---|---|---|
| To establish the MTD and recommended Phase 2 dose (or dose range as appropriate) of BMS-907351 (XL184) when administered orally on a once daily schedule in subjects with advanced or metastatic solid tumors | Within the first 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of multiple doses of BMS-907351 (XL184) administered orally on a once daily schedule in subjects with advanced or metastatic solid tumors | Day 1, 2, 5, 8, 15, 19, 20, 29 and every 2 weeks thereafter | |
| To assess plasma pharmacokinetics (PK) of oral administration of BMS-907351 (XL184) and the metabolite(s) in subjects with advanced or metastatic solid tumors |
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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 |
|---|---|
| C558660 | cabozantinib |
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| Day 1, 5, 15, 19 and 29 |
| To assess tumor response (preliminary anti-tumor activity) after repeated administration of BMS-907351 (XL184) | Every 8 weeks |
| To assess the pharmacodynamic correlates of BMS-907351 (XL184) activity | Day 1, 5, 15, 19, 29 and every 4 weeks thereafter |