Journal article

Targeted MET Inhibition in Castration-Resistant Prostate Cancer: A Randomized Phase II Study and Biomarker Analysis with Rilotumumab plus Mitoxantrone and Prednisone

Charles J Ryan, Mark Rosenthal, Siobhan Ng, Joshi Alumkal, Joel Picus, Gwenaelle Gravis, Karim Fizazi, Frederic Forget, Jean-Pascal Machiels, Sandy Srinivas, Min Zhu, Rui Tang, Kelly S Oliner, Yizhou Jiang, Elwyn Loh, Sarita Dubey, Winald R Gerritsen

CLINICAL CANCER RESEARCH | AMER ASSOC CANCER RESEARCH | Published : 2013

Abstract

PURPOSE: To evaluate the efficacy, safety, biomarkers, and pharmacokinetics of rilotumumab, a fully human, monoclonal antibody against hepatocyte growth factor (HGF)/scatter factor, combined with mitoxantrone and prednisone (MP) in patients with castration-resistant prostate cancer (CRPC). EXPERIMENTAL DESIGN: This double-blinded phase II study randomized (1:1:1) patients with progressive, taxane-refractory CRPC to receive MP (12 mg/m(2) i.v. day 1, 5 mg twice a day orally days 1-21, respectively) plus 15 mg/kg rilotumumab, 7.5 mg/kg rilotumumab, or placebo (i.v. day 1) every 3 weeks. The primary endpoint was overall survival (OS). RESULTS: One hundred and forty-four patients were randomized..

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