Effect of Ketoconazole on the Pharmacokinetics of Vinflunine

Phase 1

Completed

• Conditions: Cancer
• Interventions: Drug: vinflunine + ketaconazole

• Registration Number: NCT00388557
• Lead Sponsor: Bristol-Myers Squibb

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2006-10-16
• Study First Submitted QC: 2006-10-16
• Study First Posted: 2006-10-17
• Study Completion: 2007-09
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-16
• Last Update Posted: 2016-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	vinflunine + ketaconazole	-

Primary Outcome Measures

Name	Time	Method
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	Days 1 through 5 and Day 8 of Cycles 1 and 2

Secondary Outcome Measures

Name	Time	Method
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	weekly

Trial Locations

Locations (1)

Tennessee Oncology, Pllc; 🇺🇸 Nashville, Tennessee, United States