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

History of Changes

Tracking Information

First Received Date ^ICMJE

August 11, 2006

Last Updated Date

March 17, 2010

Start Date ^ICMJE

September 2006

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Phase I optimal food / fast recommendation [ Time Frame: throughout the study ]

Original Primary Outcome Measures ^ICMJE

Phase I optimal food / fast recommendation

Change History

Complete list of historical versions of study NCT00363194 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Clinical Activity [ Time Frame: throughout the study ]

Original Secondary Outcome Measures ^ICMJE

Clinical Activity

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Cancer

Intervention ^ICMJE

Drug: Pazopanib (GW786034)

Other Name: Pazopanib (GW786034)

Study Arm (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

June 2009

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

21 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00363194

Other Study ID Numbers ^ICMJE

VEG10005

Has Data Monitoring Committee

Responsible Party

Study Director, GSK

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

March 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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