Spots Global Cancer Trial Database for A Study of Abiraterone in Combination With SHR3162 in the Treatment of mCRPC

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Trial Identification

Brief Title: A Study of Abiraterone in Combination With SHR3162 in the Treatment of mCRPC

Official Title: A Phase I Clinical Study of Abiraterone Combined With SHR3162 in the Treatment of Metastatic Castration-resistant Prostate Cancer

Study ID: NCT04108247

Conditions

Prostate Cancer Castration-resistant Prostate Cancer

Interventions

Abiraterone+SHR3162

Study Description

Brief Summary: The aim of this trial is to evaluate the Drug-Drug interaction with Abiraterone combined with SHR3162 in the Metastatic Castration Resistant Prostate Cancer Patients.

Detailed Description: This is a multicenter, open-label Phase I trial and the aim of this trial is to evaluate the drug-drug interaction and safety with SHR3162 combined with Abiraterone in Metastatic Castration Resistant Prostate Cancer Patients. The trial is a dose-escalation and -expansion study. Approximately 35\~38 patients in will receive fixed- dose of orally Abiraterone and only one of two dose levels of orally SHR3162. The Primary endpoints are incidence of adverse events(AE) and PK characteristics. The secondary endpoints are efficacy and recommended phase 2 dose(RP2D).