Calendario›SNY›Cabazitaxel XRP6258 · PRIMCAB
Cabazitaxel XRP6258 · PRIMCAB
Cabazitaxel Versus the Switch to Alternative AR Targeted Therapy Enzalutamide or Abiraterone in Metastatic Castration-Resistant Prostate Cancer (mCRPC) Primary Resistant Patients to Abiraterone or Enzalutamide
Ensayo de Sanofi en Prostate Cancer Metastatic (del registro, en inglés).
- Fase
- Fase 2
- Estado
- Interrumpido
- Participantes
- 8
- Centros
- 24
- Fin del objetivo primario
- may 2018
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, abierto. Comenzó en jun 2015.
Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Unsatisfactory patient accrual».
Qué mide
Radiographic Progression-Free Survival (rPFS) (Baseline until tumor progression or bone lesion progression or death due to any cause (maximum duration: 1059 days)) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary Objective: To demonstrate the superiority in term of radiographic Progression-Free Survival (rPFS) of cabazitaxel at at 25 milligram per meter square (mg/m\^2) plus prednisone (Arm A) versus either enzalutamide at 160 milligram (mg) once daily or abiraterone acetate at 1000 mg once daily plus prednisone (Arm B) in chemotherapy-naïve participants with metastatic Castration-Resistant Prostate Cancer (mCRPC) who have disease progression while receiving androgen receptor (AR) targeted therapy (abiraterone plus prednisone or enzalutamide) within 12 months of treatment initiation (≤12 months). 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 in participants with measurable disease (RECIST 1.1) * Pain response and time to pain progression. * Symptomatic skeletal events (SSE) rate and time to occurrence of any SSE. * To analyze messenger ribonucleic acids (mRNAs) including androgen-receptor splice variant 7 messenger RNA (AR-V7) as a biomarker in Circulating Tumor Cells (CTCs). * To evaluate safety in the 2 treatment arms.
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Ficha completa en ClinicalTrials.gov (NCT02379390), actualizada en jun 2019.