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: Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study

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

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
    

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
    

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

Lead Sponsor: Bristol-Myers Squibb

Overall Clinical Trial Officials and Contacts

Bristol-Myers Squibb Study Director Bristol-Myers Squibb  

Information obtained from ClinicalTrials.gov on October 10, 2008

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