Effect of Ketoconazole on the Pharmacokinetics of Vinflunine
Information source: Bristol-Myers Squibb
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cancer
Intervention: vinflunine + ketaconazole (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Bristol-Myers Squibb Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb
Summary
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
Clinical Details
Official title: Effect of Ketoconazole on the Pharmacokinetics of Intravenous (IV) Vinflunine in Patients With Advanced Cancer
Study design: Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study
Primary outcome: 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
Secondary outcome: 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Tennessee Oncology, Pllc, Nashville, Tennessee 37203, United States
Additional Information
BMS Clinical Trials Disclosure For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm
Starting date: October 2005
Ending date: September 2007
Last updated: December 7, 2007
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