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Sponsored by: |
Bristol-Myers Squibb |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00388557 |
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
Condition | Intervention | Phase |
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Cancer |
Drug: vinflunine + ketaconazole |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study |
Official Title: | Effect of Ketoconazole on the Pharmacokinetics of Intravenous (IV) Vinflunine in Patients With Advanced Cancer |
Estimated Enrollment: | 35 |
Study Start Date: | October 2005 |
Study Completion Date: | September 2007 |
Arms | Assigned Interventions |
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1: Experimental |
Drug: vinflunine + ketaconazole
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
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
Study ID Numbers: | CA183-009 |
Study First Received: | October 16, 2006 |
Last Updated: | June 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00388557 |
Health Authority: | United States: Food and Drug Administration |
Clotrimazole Miconazole Tioconazole Ketoconazole |
Anti-Infective Agents Therapeutic Uses Antifungal Agents Pharmacologic Actions |