NCT04102124

A Study of SHR3680 in Combination With SHR3162 in the Treatment of mCRPC

A Phase II Clinical Study of SHR3680 Combined With SHR3162 in the Treatment of Metastatic Castration-resistant Prostate Cancer Previously Treated With Abiraterone and Docetaxel

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (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 SHR3680 combined with SHR3162 and SHR3680 single drug to improve Metastatic Castration Resistant Prostate Cancer Patients whether the patient's overall survival (OS) is superior to placebo.

Detailed description

This is a multicenter, randomized , double-blind Phase II trial and the aim of this trial is to evaluate SHR3680 combined with SHR3162 and SHR3680 single drug to improve Metastatic Castration Resistant Prostate Cancer Patients Previously Treated With Abiraterone and Docetaxel whether the patient's overall survival (OS) is superior to placebo. The Stage I part is a dose-escalation and -expansion study. Approximately 18\~24 patients in Stage I will receive fixed-dose of orally SHR3680 and only one of two dose levels of orally SHR3162. The Primary endpoints of the Stage I are incidence of adverse events(AE) and recommended phase 2 dose(RP2D). The Stage II part is a randomized , double-blind study. Approximately 90\~120 patients in Stage II will receive SHR3162 combined with SHR3680, in which one fixed-dose levels of SHR3162 will be selected based on the result of the Stage I.The Primary endpoint of the Stage II is overall survival(OS).

Conditions

• Prostate Cancer
• Castration-resistant Prostate Cancer

Interventions

Type	Name	Description
DRUG	SHR3680	Tablet. Specifications of 80mg
DRUG	SHR3162	Tablet. Specifications of 10mg、40mg、50mg and 100mg
DRUG	SHR3680(Placebo)	Tablet. Specifications of 80mg
DRUG	SHR3162(Placebo)	Tablet. Specifications of 10mg、40mg、50mg and 100mg

Timeline

• Start date: 2019-04-08
• Primary completion: 2021-08-31
• Completion: 2021-08-31
• First posted: 2019-09-25
• Last updated: 2025-06-24

Locations

1 site across 1 country: China