Sample size consideration
mCRPC
METASTATIC CASTRATION-RESISTANT PROSTATE CANCER
To support registration of patients with metastatic castration-resistant prostate cancer (mCRPC) and other future potential indications in China, it was determined that 12 evaluable patients were needed to characterize the Chinese PK profile. This number was based on available global talazoparib PK data and with the intention to satisfy regulatory requirements by the China National Medical Products Administration for PK evaluation in a Chinese population. Considering there will be non-evaluable patients, it was estimated that approximately 15 patients were needed to be enrolled.