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Effect of Rifampin on the Pharmacokinetics of Intravenous (IV) Vinflunine in Subjects With Advanced Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

Effect of Rifampin on the Pharmacokinetics of Intravenous (IV) Vinflunine in Subjects With Advanced Cancer


Inclusion Criteria:



- Cancer unresponsive to previous treatment

- Consent for genetic samples

Exclusion Criteria:

- Cancer of the blood

- Spread of cancer to the brain

- Moderate or severe nerve damage

- Low white blood cell counts and platelet counts

- Inadequate liver or kidney function

- Prior treatment with vinflunine

- Use of certain medications that might interfere with the metabolism of vinflunine

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The Primary Outcome Measure of the effect of rifampin on the pharmacokinetics (PK) of intravenous (IV) vinflunine will be determined from the PK measurements

Outcome Time Frame:

taken during Cycle 2 of study treatment, at approximately 4 weeks after the start of study treatment

Authority:

United States: Food and Drug Administration

Study ID:

CA183-033

NCT ID:

NCT00534807

Start Date:

September 2007

Completion Date:

November 2008

Related Keywords:

  • Cancer

Name

Location

Local Institution Detroit, Michigan