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Effect of Ketoconazole on the Pharmacokinetics of Vinflunine

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ClinicalTrials.gov Identifier: NCT00388557
Recruitment Status : Completed
First Posted : October 17, 2006
Last Update Posted : September 19, 2016
Sponsor:
Information provided by:
Bristol-Myers Squibb

Study Description
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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

Condition or disease Intervention/treatment Phase
Cancer Drug: vinflunine + ketaconazole Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Ketoconazole on the Pharmacokinetics of Intravenous (IV) Vinflunine in Patients With Advanced Cancer
Study Start Date : October 2005
Actual Study Completion Date : September 2007

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00388557


Locations
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United States, Tennessee
Tennessee Oncology, Pllc
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00388557    
Other Study ID Numbers: CA183-009
First Posted: October 17, 2006    Key Record Dates
Last Update Posted: September 19, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Ketoconazole
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