Extension Study to VEG105192 to Assess Pazopanib in Patients With Advanced/Metastatic Renal Cell Cancer - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00387764

Purpose

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.

Condition	Intervention	Phase
Advanced Renal Cell Carcinoma Carcinoma, Renal Cell	Drug: pazopanib	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-label Extension Study to Assess the Safety and Efficacy of Pazopanib in Subjects With Renal Cell Carcinoma Previously Enrolled on Protocol VEG105192

Resource links provided by NLM:

MedlinePlus related topics: Cancer MRI Scans Nuclear Scans

Drug Information available for: Pazopanib

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Incidence, severity and causality of all adverse events (AE), serious adverse events (SAEs) and other safety parameters Subjects will have a CT/MRI scan every 6 weeks until week 24 and every 12 weeks thereafter [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Response rate, Progression free survival, Overall survival. Subjects will have a CT/MRI scan every 6 weeks until week 24 and every 12 weeks thereafter [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	132
Study Start Date:	September 2006
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: pazopanib arm This was a single arm study, therefore no control arm.	Drug: pazopanib 800 mg daily dosing continously until progression Other Name: pazopanib

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Progressed from VEG105192 study treatment
Patient's VEG105192 was placebo
Baseline has good organ function

Exclusion criteria:

No brain metastasis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00387764

Show 46 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00387764 History of Changes
Other Study ID Numbers:	VEG107769
Study First Received:	October 12, 2006
Last Updated:	December 21, 2011
Health Authority:	Austria: Ethikkommission; United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

renal cell carcinoma
pazopanib
anti-angiogenic therapy
open label

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma

Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on February 09, 2012