Safety and Efficacy of GW786034 (Pazopanib) In Metastatic Renal Cell Carcinoma
Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
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.