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Cabazitaxel · PROSELICA

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

Ensayo de Sanofi en Cancer de prostata.

Más ensayos de: Cáncer de próstata.

Fase

Fase 3

Estado

Completado

Participantes

1.200

previstos

Centros

172

Fin del objetivo primario

ago 2015

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en abr 2011.

Qué mide

Overall Survival (OS) (From baseline up to death due to any cause or study cut-off date, whichever was earlier (maximum duration: 48 months)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary 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.

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Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01308580), actualizada en mar 2017.