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A Two-way Crossover Study Of The Effect Of Food On The Pharmacokinetics Of Pazopanib In Cancer Patients

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00363194
First received: August 11, 2006
Last updated: March 17, 2010
Last verified: March 2010
  Purpose

This is two-part study (Part I/Part II). Part I is designed to determine the effect of a low and high fat meal on the pharmacokinetics of single dose pazopanib (GW572016). Part II is designed to allow patients continued access to study drug in a multiple dosing regimen. Patients who are receiving clinical benefit on that regimen will go into the long term rollover study VEG105430 provided they are stable for 8 weeks.


Condition Intervention Phase
Cancer
Drug: Pazopanib (GW786034)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Phase I optimal food / fast recommendation [ Time Frame: throughout the study ]

Secondary Outcome Measures:
  • Clinical Activity [ Time Frame: throughout the study ]

Estimated Enrollment: 28
Study Start Date: September 2006
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Pazopanib (GW786034)
    Other Name: Pazopanib (GW786034)
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00363194

Locations
United States, Indiana
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
United States, Michigan
GSK Investigational Site
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00363194     History of Changes
Other Study ID Numbers: VEG10005
Study First Received: August 11, 2006
Last Updated: March 17, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Pazopanib GW786034 Advanced cancer Metastatic cancer

ClinicalTrials.gov processed this record on November 23, 2014