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Effect of Ketoconazole on the Pharmacokinetics of Vinflunine

This study has been completed.
Information provided by:
Bristol-Myers Squibb Identifier:
First received: October 16, 2006
Last updated: September 16, 2016
Last verified: September 2016
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

Condition Intervention Phase
Drug: vinflunine + ketaconazole
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Ketoconazole on the Pharmacokinetics of Intravenous (IV) Vinflunine in Patients With Advanced Cancer

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome 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 Outcome 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 ]

Estimated Enrollment: 35
Study Start Date: October 2005
Study Completion Date: September 2007
Arms Assigned Interventions
Experimental: 1 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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00388557

United States, Tennessee
Tennessee Oncology, Pllc
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Study Director, Bristol-Myers Squibb Identifier: NCT00388557     History of Changes
Other Study ID Numbers: CA183-009 
Study First Received: October 16, 2006
Last Updated: September 16, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators processed this record on October 21, 2016