Effect of Ketoconazole on the Pharmacokinetics of Vinflunine

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

Tracking Information

• First Submitted Date: October 16, 2006
• First Posted Date: October 17, 2006
• Last Update Posted Date: September 19, 2016
• Study Start Date: October 2005
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: May 3, 2007): 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 ]
• Original Primary Outcome Measures (submitted: October 16, 2006): 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 on Days 1 through 5 and Day 8 of Cycles 1 and 2
• Current Secondary Outcome Measures (submitted: May 3, 2007): 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 ]
• Original Secondary Outcome Measures (submitted: October 16, 2006): 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.
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Ketoconazole on the Pharmacokinetics of Vinflunine
• Official Title: Effect of Ketoconazole on the Pharmacokinetics of Intravenous (IV) Vinflunine in Patients With Advanced Cancer
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Cancer

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

Study Arms

Experimental: 1

Intervention: Drug: vinflunine + ketaconazole

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: October 16, 2006): 35
• Original Enrollment: Same as current
• Actual Study Completion Date: September 2007
• Primary Completion Date: Not Provided

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00388557
• Other Study ID Numbers: CA183-009
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Study Director, Bristol-Myers Squibb
• Study Sponsor: Bristol-Myers Squibb
• Collaborators: Not Provided

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

• PRS Account: Bristol-Myers Squibb
• Verification Date: September 2016