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Cabazitaxel Versus Docetaxel Both With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer

Sanofi · 2011
ClinicalTrials.gov · Datasets · License: Public Domain · 2011
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prostate-cancer
Primary Objective: * To demonstrate the superiority of cabazitaxel plus prednisone at 25 mg/m\^2 (Arm A) or 20 mg/m\^2 (Arm B) versus docetaxel plus prednisone (Arm C) in term of overall survival (OS) in participants with metastatic castration resistant prostate cancer (mCRPC) and not previously treated with chemotherapy. Secondary Objectives: * To evaluate safety in the 3 treatment arms. * To compare efficacy of cabazitaxel at 20 mg/m\^2 and 25 mg/m\^2 to docetaxel for: * Progression Free Survival (PFS) (RECIST 1.1) * Tumor progression free survival (RECIST 1.1) * Tumor response in participants with measurable disease (RECIST 1.1), * PSA response * PSA-Progression free survival (PSA-PFS). * Pain response in participants with stable pain at baseline * Pain progression free survival * Time to occurrence of any skeletal related events (SRE) * To compare Health-Related Quality of Life (HRQL). * To assess the pharmacokinetics and pharmacogenomics of cabazitaxel.
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