Effect of Ketoconazole on the Pharmacokinetics of Vinflunine

September 16, 2016 updated by: Bristol-Myers Squibb

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology, PLLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Days 1 through 5 and Day 8 of Cycles 1 and 2

Secondary Outcome Measures

Outcome Measure
Time Frame
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
weekly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

October 16, 2006

First Submitted That Met QC Criteria

October 16, 2006

First Posted (Estimate)

October 17, 2006

Study Record Updates

Last Update Posted (Estimate)

September 19, 2016

Last Update Submitted That Met QC Criteria

September 16, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA183-009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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