CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 417 target
Drug / intervention
HC-1119 +1 moredrug
Likely dose
Not stated in record
Key inclusion· 9
  • ✓Males aged ≥18 years
  • ✓Histologically or cytologically confirmed prostate adenocarcinoma without small cell features
  • ✓Progressive disease on castration by PSA, soft tissue, or bone progression
  • ✓Metastatic disease confirmed by imaging
Key exclusion· 11
  • ✕Anti-prostate cancer treatment within 4 weeks before randomization
  • ✕Palliative radiotherapy/surgery must be completed >14 days prior to baseline imaging
  • ✕Prior novel androgen receptor inhibitors (enzalutamide, apalutamide, darolutamide, SHR3680, proxalutamide, HC-1119)
  • ✕Serious cardiovascular disease including MI/thrombotic event in past 6 months, unstable angina, NYHA Grade III/IV heart failure, QT >500 ms, or uncontrolled hypertension

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03851640
NCT03851640Phase 3RecruitingUpdate OverdueUpdated 15mo ago · Completion was 9mo ago
Enrollment Stalled
Long Recruiting
Update Overdue
CompareCT.gov

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.

Hinova Pharmaceuticals Inc.·interventional·Posted Feb 22, 2019·Updated Mar 12, 2025

In Brief

A Phase 3 clinical trial evaluating HC-1119 and placebo for MCRPC. Currently recruiting, targeting 417 participants across 1 site.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMCRPC
CountriesChina
Collaborators--

Timeline

Phase 3RecruitingOverdue
20192020202120222023202420252026
First PostedFeb 22, 2019
Enrollment StartApr 12, 2019
Primary CompletionSep 1, 2025
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 7.4 years ago

Interventions

HC-1119drug

oral

placebodrug

oral