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The purpose of the study is to test how vinflunine interacts with ixabepilone in the human body.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vinflunine + ixabepilone | Drug | solution for injection, IV, vinflunine: 250 to 320 mg/m2 + ixabepilone: 30 to 40 mg/m2, every 3 wks, variable duration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine the maximum tolerated dose and describe any dose limiting toxicities of ixabepilone and vinflunine in an alternating regimen. | upon occurrence |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the overall safety profile, efficacy and rate and extent to which ixabepilone and vinflunine are absorbed or otherwise available to the treatment site in the body. | upon occurrence |
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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 |
|---|---|---|---|---|---|---|
| University Of Miami Miller School Of Medicine | Miami | Florida | 33136 | United States | ||
| The Cleveland Clinic Foundation |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C111217 | vinflunine |
| C430592 | ixabepilone |
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| Cleveland |
| Ohio |
| 44195 |
| United States |