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The purpose of the study is to test how ketoconazole affects with handling of vinflunine by the body which might affect how much vinflunine is in the blood stream and for how long
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vinflunine + ketaconazole | Drug | vinflunine solution for injection, ketaconazole tablets, vinflunine IV, ketaconazole oral, vinflunine 80 to 320mg/m2 + ketaconazole 400 mg, vinflunine every 3 wks, ketaconazole C1 only, variable duration |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the effect of ketoconazole on the pharmacokinetics of vinflunine in patient with advanced cancer. A total of 28 blood samples will be collected | Days 1 through 5 and Day 8 of Cycles 1 and 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety of vinflunine co-administered with ketoconazole and assess the safety of vinflunine in patients with advanced cancer. Safety laboratory assessments and evaluations will be collected | weekly |
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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 |
|---|---|---|---|---|---|---|
| Tennessee Oncology, Pllc | Nashville | Tennessee | 37203 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C111217 | vinflunine |
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