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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Carcinoma, Renal Cell

Treatments: Drug: pazopanib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00387764

VEG107769

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• No brain metastasis

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

pazopanib arm

Experimental group

Description:

This was a single arm study, therefore no control arm.

Treatment:

Drug: pazopanib