Effect of Ketoconazole on the Pharmacokinetics of Vinflunine

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Cancer

Treatments: Drug: vinflunine + ketaconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00388557

CA183-009

Details and patient eligibility

About

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

Enrollment: 35 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 1 patient group

1

Experimental group

Treatment:

Drug: vinflunine + ketaconazole