NCT03851640

A Trial Evaluating the Efficacy and Safety of HC-1119 Soft Capsules in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC).

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of HC-1119 Soft Capsules in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Have Failed Treatments with Abiraterone Acetate and Docetaxel.

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 417 (estimated)
• Sponsor: Hinova Pharmaceuticals Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, placebo-controlled, Phase 3 clinical study evaluating the efficacy and safety of HC-1119 soft capsules versus placebo in mCRPC patients who have failed or become intolerant to the treatments with both abiraterone acetate and docetaxel, or who are not suitable for docetaxel treatment.

Conditions

• MCRPC

Interventions

Type	Name	Description
DRUG	HC-1119	oral
DRUG	placebo	oral

Timeline

• Start date: 2019-04-12
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2019-02-22
• Last updated: 2025-03-12

Locations

1 site across 1 country: China