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

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.

Trial Details

NCT ID
NCT03851640
Phase
PHASE3
Sponsor
Hinova Pharmaceuticals Inc.
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • HC-1119
  • placebo
Locations (sample)
  • Shanghai, China|31.22222,121.45806

Key Eligibility Criteria

  • Males aged ≥18 years at screening and voluntary to participate in the study and sign the informed consent form.
  • Subjects with histologically or cytologically confirmed prostate adenocarcinoma, with no small cell features.
  • In the case of medical or surgical castration, during or after the last treatment before screening, there are signs of progressive disease determin…
  • PSA progression; at least 2 episodes of increased PSA levels that are measured ≥1 week apart; PSA ≥ 1 μg/L (1 ng/mL) in the screening period;

For full eligibility, visit ClinicalTrials.gov.

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