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
21 Years
N/A
Not Enrolling
Both
Cancer
Both
Cancer
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 |
