NCT00387764

Extension Study to VEG105192 to Assess Pazopanib in Patients With Advanced/Metastatic Renal Cell Cancer

An Open-label Extension Study to Assess the Safety and Efficacy of Pazopanib in Subjects With Renal Cell Carcinoma Previously Enrolled on Protocol VEG105192

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, international, multi-center study designed to provide access to pazopanib for subjects who have been enrolled in the Phase III renal cell carcinoma study (VEG105192) and have progressed on placebo. Subjects will receive 800 mg pazopanib once daily. The study treatment will continue until subjects experience disease progression, unacceptable toxicity, withdrawal of consent, or death. The primary objective of the study is to evaluate the safety and tolerability of pazopanib for the treatment of renal cell carcinoma. The secondary objectives of the study are to assess response rate (defined as complete response or partial response), progression-free survival, and overall survival. Response rates will be collected per investigator assessment (no central review). Subjects will have a CT/MRI scan every 6 weeks until week 24 and every 12 weeks thereafter.

Conditions

• Carcinoma, Renal Cell

Interventions

Type	Name	Description
DRUG	pazopanib	800 mg daily dosing continously until progression

Timeline

• Start date: 2006-09-01
• Primary completion: 2009-12-01
• Completion: 2012-10-01
• First posted: 2006-10-13
• Last updated: 2014-01-14
• Results posted: 2013-12-03

Locations

58 sites across 20 countries: Argentina, Australia, Austria, Brazil, Chile, China, Czechia, Estonia, Italy, Latvia, Lithuania, New Zealand, Pakistan, Poland, Russia, Slovakia, South Korea, Tunisia, Ukraine, United Kingdom