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NCT00388557 Clinical Trial

Effect of Ketoconazole on the Pharmacokinetics of Vinflunine

Cancer Clinical Trial

Official title:
Effect of Ketoconazole on the Pharmacokinetics of Intravenous (IV) Vinflunine in Patients With Advanced Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00388557
Other study ID # CA183-009
Secondary ID
Status Completed
Phase Phase 1
First received October 16, 2006
Last updated September 16, 2016
Start date October 2005
Est. completion date September 2007

Study information
Verified date September 2016
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 35
Est. completion date September 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Tennessee Oncology, Pllc Nashville Tennessee

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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