Cabazitaxel at 20 mg/m² Compared to 25 mg/m² With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer

• Status: Completed
• Trial end date: 2015-08-01

Summary

Primary Objective:

• To demonstrate the non inferiority in term of overall survival (OS) of Cabazitaxel 20 mg/m² (Arm A) versus Cabazitaxel 25 mg/m² (Arm B) in combination with prednisone in participants with metastatic castration resistant prostate cancer (mCRPC) previously treated with a docetaxel-containing regimen.

Secondary Objectives:

• To evaluate safety in the 2 treatment arms and to assess if Cabazitaxel 20 mg/m² was better tolerated than Cabazitaxel 25 mg/m².

• To compare efficacy of Cabazitaxel at 20 mg/m² and 25 mg/m² for:

• Progression Free Survival (PFS) defined as the first occurrence of any of the following events: tumor progression per Response Evaluation Criteria In Solid Tumors (RECIST), prostate-specific antigen (PSA) progression, pain progression or death due to any cause;

• PSA Progression;

• Pain progression;

• Tumor response in participants with measurable disease (RECIST 1.1);

• PSA response;

• Pain response in participants with stable pain at baseline.

• To compare Health-related Quality of Life (HRQoL).

• To assess the pharmacokinetics and pharmacogenomics of Cabazitaxel.

• Phase: Phase 3

Details

• Lead Sponsor: Sanofi
• Treatments: Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone