Clinical Trial: NCT03851640
A Trial Evaluating the Efficacy and Safety of HC-1119 Soft Capsules in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC).
Status:
RECRUITINGPhase:
Phase 3| Lead Sponsor: | Hinova Pharmaceuticals Inc. |
| Information Provided By: | Hinova Pharmaceuticals Inc. |
| Last Update Posted: | 2025-03-12 |
Study Overview
Brief 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.
Official Title
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.
Conditions
MCRPC
Intervention / Treatment
- Drug: HC-1119
- Drug: placebo
Other Study ID Numbers
- HC-1119-04
Start Date (Actual)
2019-04-12
Primary Completion Date (Estimated)
2025-09
Study Completion Date (Estimated)
2025-09
Enrollment (Estimated)
417
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Hinova Pharmaceuticals Inc. |
| Information Provided By: | Hinova Pharmaceuticals Inc. |
| Last Update Posted: | 2025-03-12 |
Study Overview
Brief 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.
Official Title
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.
Conditions
MCRPC
Intervention / Treatment
- Drug: HC-1119
- Drug: placebo
Other Study ID Numbers
- HC-1119-04
Start Date (Actual)
2019-04-12
Primary Completion Date (Estimated)
2025-09
Study Completion Date (Estimated)
2025-09
Enrollment (Estimated)
417
Study Type
Interventional
Phase
Phase 3