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The purpose of this study is to determine the DLT, MTD and recommended Phase II dose of ixabepilone in Japanese patients with solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ixabepilone | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ixabepilone | Drug | Lyophilized and solvent, IV, 10-50 mg/m2, Q3W, At least 1 cycle, (21 days) |
|
| Measure | Description | Time Frame |
|---|---|---|
| To establish the maximum tolerated dose (MTD), and a recommended Phase II dose of Ixabepilone when administered every three weeks by assessing status of treatment, dose intensity, and dose-limiting toxicities (DLT) | 3-week treatment cycles until unacceptable toxicity |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate safety by assessing adverse events. Toxicity will be evaluated according to the Common Toxicity Criteria Version 3.0 (CTC). Response will be evaluated according to the RECIST (Response Evaluation Criteria in Solid Tumors) criteria | 3-week treatment cycles | |
| To evaluate the plasma pharmacokinetics of Ixabepilone according to the following parameters: Cmax, AUC(INF), Tmax, t1/2, MRT(INF), Vss, Cltot |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
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| ID | Term |
|---|---|
| C430592 | ixabepilone |
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| Cycle 1 (first 3 weeks of study therapy) |
| To describe any preliminary evidence of anti-tumor activity (response), assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) | 3-week treatment cycles until unacceptable toxicity |