Conditions: Carcinoma, Renal Cell
Keywords: Metastatic Anti-angiogenesis GW786034 Pazopanib
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 435
Healthy volunteers: no

Brief summary:
To evaluate efficacy and safety of pazopanib compared to placebo in patients with locally advanced and/ or metastatic renal cell carcinoma (RCC). Approximately 350-400 eligible patients will be stratified and randomized in a 2:1 ratio to receive either 800 mg pazopanib once daily or matching placebo. The study treatment will continue until patients experience disease progression, unacceptable toxicity or death. Primary objective of the study is to evaluate and compare the two treatment arms for progression-free survival. Principal secondary objective is to evaluate and compare the two treatment arms with respect to overall survival. Other objectives are overall response rate \[complete response (CR) + partial response (PR)\], rate of CR + PR + 6 months stable disease, and the incidence, severity and causality of adverse events and serious adverse events. Safety and efficacy assessments will be regularly performed on all patients. An Independent Data Monitoring Committee will be established to monitor safety during the course of the study and to evaluate interim efficacy data on overall survival.

Detailed description:

Arms:
arm 1: matching placebo (800 mg tablet) once daily arm 2: Oral pazopanib tablet 800 mg once daily continuously

Interventions: intervention 1: Pazopanib intervention 2: placebo
Intervention descriptions: intervention 1: Oral pazopanib tablet 800 mg once daily continuously intervention 2: matching placebo (800 mg tablet) once daily

Protocol document: