A Study of the Interaction of Rifampin and Vinflunine in Subjects With Advanced Cancer
Phase 1
Withdrawn
- Conditions
- Cancer
- Registration Number
- NCT00534807
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to test how vinflunine interacts with rifampin in the human body
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Cancer unresponsive to previous treatment
- Consent for genetic samples
Exclusion Criteria
- Cancer of the blood
- Spread of cancer to the brain
- Moderate or severe nerve damage
- Low white blood cell counts and platelet counts
- Inadequate liver or kidney function
- Prior treatment with vinflunine
- Use of certain medications that might interfere with the metabolism of vinflunine
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method The Primary Outcome Measure of the effect of rifampin on the pharmacokinetics (PK) of intravenous (IV) vinflunine will be determined from the PK measurements taken during Cycle 2 of study treatment, at approximately 4 weeks after the start of study treatment
- Secondary Outcome Measures
Name Time Method The Secondary Outcome Measures of the safety and tolerability of vinflunine when administered alone and with rifampin determined after 2 complete 21-day Cycles of study treatment, at approximately 6 weeks after the start of study treatment
Trial Locations
- Locations (1)
Local Institution
🇺🇸Detroit, Michigan, United States