NCT04108247

A Study of Abiraterone in Combination With SHR3162 in the Treatment of mCRPC

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Prostate Cancer Castration-resistant Prostate Cancer

Interventions

Type	Name	Description
DRUG	Abiraterone+SHR3162	Participants will receive Abiraterone combined with SHR3162 orally

Timeline

• Start date: 2019-09-26
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2019-09-30
• Last updated: 2022-07-07

Locations

1 site across 1 country: China