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

Phase 1

Completed

• Conditions: Carcinoma, Renal Cell
• Interventions: Drug: Pazopanib (GW786034)

• Registration Number: NCT00363194
• Lead Sponsor: GlaxoSmithKline

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

Not available

Study Timeline

• Study First Submitted: 2006-08-11
• Study First Submitted QC: 2006-08-11
• Study First Posted: 2006-08-15
• Study Start: 2006-09-21
• Primary Completion: 2009-06-19
• Study Completion: 2009-06-19
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-13
• Last Update Posted: 2017-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lead-In cohort	Pazopanib (GW786034)	In Part 1 of Lead-In cohort, subjects will be dosed with a single dose of pazopanib with a high-fat breakfast to establish safety and tolerability.

Primary Outcome Measures

Name	Time	Method
PK parameters: Cmax, tmax, and AUC	Day 1 and Day 15

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability parameters include evaluation of adverse events (AEs), and changes in clinical laboratory, and vital signs assessments under fed and fasted conditions	14 weeks

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Detroit, Michigan, United States