Phase II study of Sorafenib (BAY 43–9006) in hormone-refractory patients with prostate cancer: A study of the Central European Society for Anticancer Drug Research—EWIV (CESAR)

3094 Background: Sorafenib (BAY 43–9006) is a novel, orally active multi-kinase inhibitor with anti-angiogenic and anti-proliferative activity, blocking both Raf/MEK/ERK pathway and receptor tyrosine kinases VEGFR-2 and PDGFR. Activity of sorafenib in hormone-refractory progressive patients (pts) with prostate cancer (PC) was investigated in a Phase II clinical study. Methods: Pts received sorafenib 400 mg bid by continuous oral dosing. Pts with progressive disease during hormonal treatment and no prior chemotherapy therapy for advanced prostate cancer, and either one uni-dimensional measurable lesion according to RECIST-criteria or increasing PSA values reflecting a hormone-refractory situation, were eligible for study entry. Tumor PSA-based response was defined as: increase of PSA from baseline or lowest measured value by 100% = progressive disease (PD); decrease of PSA by >50% in two consecutive measurements = responder; PSA levels in between the two definitions above = stable disease (SD). Primary stu...