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An Open-Label, Two-Period, Randomized, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of Single Doses of Pazopanib in Cancer Patients


Phase 1
21 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

An Open-Label, Two-Period, Randomized, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of Single Doses of Pazopanib in Cancer Patients

Inclusion Criteria


Inclusion criteria:

- Confirmed advanced solid tumor(s)

- Must have adequate blood, liver, and kidney function.

- Must be willing to abstain from intercourse from 2 weeks prior to administration of
the first dose of study medication until 28 days after the final dose of study
medication or be willing to consistently and correctly use an acceptable method of
birth control.

Exclusion criteria:

- Patients with certain heart problems or history of bleeding within a month.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase I optimal food / fast recommendation

Outcome Time Frame:

throughout the study

Principal Investigator

GSK Clinical Trials, MD

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

VEG10005

NCT ID:

NCT00363194

Start Date:

September 2006

Completion Date:

June 2009

Related Keywords:

  • Cancer
  • Pazopanib GW786034 Advanced cancer Metastatic cancer

Name

Location
GSK Investigational Site Indianapolis, Indiana  46260
GSK Investigational Site Royal Oak, Michigan  48073