LBA4510 Background: BAY 43–9006 (BAY), a dual-action Raf kinase and VEGFR inhibitor, inhibits tumor cell proliferation and angiogenesis. In Phase II trials, BAY has demonstrated activity in patients (pts) with metastatic RCC. The primary aim of this Phase III, double-blind trial was to assess overall survival (OS) in pts with confirmed advanced clear-cell RCC randomized to BAY vs best supportive care (BSC). Results of a planned analysis on the secondary endpoint, progression free survival (PFS) will be presented in this report. Methods: Pts (ECOG 0–1) who had received one prior systemic therapy for advanced RCC were stratified into intermediate- (1–2 risk factors) or low-risk (no risk factors) groups, according to the MSKCC prognostic index. Pts were randomized to receive continuous BAY 400 mg bid or matched placebo with BSC. Pts were withdrawn from the study if they met any of the following criteria: AEs requiring study drug termination; progressive disease (unless continued treatment was considered appr...