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The purpose of this study is to evaluate the tolerability and safety profile of BMS-833923 (XL139) when orally administered on a once daily schedule.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: BMS-833923 (XL139) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-833923 (XL139) | Drug | Capsule, Oral, 150 mg, 300 mg, or 450 mg,Once daily, Until progression of disease, unacceptable toxicity, withdrawal of subject's consent or meeting other discontinuation criteria |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Dose Limiting Toxicity (DLT) and observed adverse events | Within the first 28 days of treatment | |
| Incidence of Dose Limiting Toxicity (DLT) and observed adverse events | Up to 90 days additional treatment period plus 60 days of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| The number of subjects experienced DLT | Within the first 28 days | |
| Maximum observed concentration (Cmax) of BMS-833923 (XL139) | Day1 and Day 29 | |
| Trough observed concentration (Cmin) of BMS-833923 (XL139) |
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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 | Kashiwa-shi | Chiba | 2778577 | Japan |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C583051 | BMS-833923 |
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| Day1 and Day 29 |
| Time of maximum observed concentration (Tmax) of BMS-833923 (XL139) | Day1 and Day 29 |
| Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-833923 (XL139) | Day1 and Day 29 |
| Effective half-life (T-half,eff) of BMS-833923 (XL139) | Day1 and Day 29 |
| Accumulation index (AI) of BMS-833923 (XL139) | Day1 and Day 29 |
| Best overall response assessed according to Response evaluation criteria in solid tumors (RECIST) v1.1 criteria | Up to120 days of treatment period |