Journal article

A randomised, double-blind phase III study of pazopanib in patients with advanced and/or metastatic renal cell carcinoma: Final overall survival results and safety update

Cora N Sternberg, Robert E Hawkins, John Wagstaff, Pamela Salman, Jozef Mardiak, Carlos H Barrios, Juan J Zarba, Oleg A Gladkov, Eunsik Lee, Cezary Szczylik, Lauren McCann, Stephen D Rubin, Mei Chen, Ian D Davis

EUROPEAN JOURNAL OF CANCER | ELSEVIER SCI LTD | Published : 2013

Abstract

BACKGROUND: In this randomised phase III study (VEG105192; NCT00334282), pazopanib previously demonstrated statistically and clinically meaningful improvement of progression-free survival versus placebo in patients with advanced/metastatic renal cell carcinoma (mRCC). Final overall survival (OS) and updated safety results are now reported. METHODS: Treatment-naive or cytokine-pretreated mRCC patients (n=435) stratified and randomised (2:1) to pazopanib 800 mg daily or placebo, were treated until disease progression, death or unacceptable toxicity. Upon progression, placebo patients could receive pazopanib through an open-label study. Final OS in the intent-to-treat population was analysed us..

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University of Melbourne Researchers