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

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase III Treatment Active 18 and over Pharmaceutical / Industry VEG107769
NCT00387764

Trial Description

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.

Eligibility Criteria

Inclusion criteria:

Progressed from VEG105192 study treatment

Patient's VEG105192 was placebo

Baseline has good organ function

Exclusion criteria:

No brain metastasis

Trial Contact Information

Trial Lead Organizations/Sponsors

GlaxoSmithkline

GSK Clinical Trials, MD

Study Director

US GSK Clinical Trials Call Center

Ph: 877-379-3718

Trial Sites

Argentina

Cordoba

GSK Investigational Site

Quilmes

GSK Investigational Site

Tucuman

GSK Investigational Site

Australia

New South Wales

Waratah

GSK Investigational Site

Victoria

Heidelberg

GSK Investigational Site

Brazil

Belo Horizonte

GSK Investigational Site

Chile

Viña del Mar

GSK Investigational Site

Czech Republic

Praha 2

GSK Investigational Site

New Zealand

Christchurch

GSK Investigational Site

Newtown, Wellington

GSK Investigational Site

Poland

Gdansk

GSK Investigational Site

Krakow

GSK Investigational Site

Kraków

GSK Investigational Site

Republic of Korea

Seoul

GSK Investigational Site

songpa-gu, Seoul

GSK Investigational Site

Russia

Moscow

GSK Investigational Site

Tunisia

Sousse

GSK Investigational Site

Tunis

GSK Investigational Site

United Kingdom

Manchester

GSK Investigational Site

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00387764
Information obtained from ClinicalTrials.gov on May 13, 2009

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.