Calendario›SNY›cabazitaxel XRP6258 · CARD
cabazitaxel XRP6258 · CARD
Cabazitaxel Versus the Switch to Alternative AR-targeted Agent (Enzalutamide or Abiraterone) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Patients Previously Treated With Docetaxel and Who Rapidly Failed a Prior AR-targeted Agent
Ensayo de Sanofi en Prostate Cancer Metastatic (del registro, en inglés).
- Fase
- Fase 4
- Estado
- Completado
- Participantes
- 255
- Centros
- 65
- Fin del objetivo primario
- mar 2019
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, abierto. Comenzó en nov 2015.
Qué mide
Radiographic Progression-Free Survival (rPFS) (From randomization until tumor progression or bone lesion progression, death due to any cause, or data cut-off date whichever comes first (maximum duration: up to 141 weeks)) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary Objective: To compare the radiographic progression-free survival (rPFS) (using Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1 for tumor lesions and Prostate Cancer Working Group 2 (PCWG2) criteria for bone scan lesions or death due to any cause) with chemotherapy (cabazitaxel plus prednisone, Arm A) versus Androgen Receptor (AR)-targeted therapy (enzalutamide or abiraterone acetate plus prednisone, Arm B) in mCRPC participants who have been treated with docetaxel and who had disease progression while receiving AR-targeted therapy within 12 months of AR treatment initiation (less than or equal to \[\<=\]12 months, either before or after docetaxel). Secondary Objective: * To compare efficacy for: * Prostate-specific antigen (PSA) response rate and time to PSA progression (TTPP). * Progression-free survival (PFS). * Overall survival (OS). * Tumor response rate and duration of tumor response. * Pain response and time to pain progression. * Symptomatic skeletal event (SSE) rate and time to occurrence of any SSE. * Health status and Health-related Quality of Life (HRQOL). * To evaluate the correlation of a signature of resistance to AR-targeted agents with clinical outcome via the analysis of circulating tumor cell (CTC) phenotypes as well as expression and localization of proteins including AR isoforms in CTCs. * To evaluate safety in the 2 treatment arms.
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Ficha completa en ClinicalTrials.gov (NCT02485691), actualizada en may 2022.