Effect of Ketoconazole on the Pharmacokinetics of Vinflunine

Bristol-Myers Squibb35 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cancer

Interventions

vinflunine + ketaconazoleDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Tennessee Oncology, Pllc

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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