Effect of Ketoconazole on the Pharmacokinetics of Vinflunine
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...
Brief Summary
Official Title: “Effect of Ketoconazole on the Pharmacokinetics of Intravenous (IV) Vinflunine in Patients With Advanced Cancer”
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
- Study Type: Interventional
- Study Design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- 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
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
Outcome Measures for this Clinical Trial
Primary Measures
- 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
- Time Frame: Days 1 through 5 and Day 8 of Cycles 1 and 2
- Time Frame: Days 1 through 5 and Day 8 of Cycles 1 and 2
Secondary Measures
- 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
- Time Frame: weekly
- Time Frame: weekly
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Advanced cancer excluding cancer within the blood, adequate kidney and liver function.
Exclusion Criteria:
- Prior use of vinflunine, other active medical disorders, severe nerve damage
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Bristol-Myers Squibb Industry
Overall Clinical Trial Officials and Contacts
Bristol-Myers Squibb Study Director Bristol-Myers Squibb
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00388557
Study ID Number: CA183-009
ClinicalTrials.gov Identifier: NCT00388557
Health Authority: United States: Food and Drug Administration
BMS Clinical Trials Disclosure
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00388557
