RecruitingPhase 3NCT03851640

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.


Sponsor

Hinova Pharmaceuticals Inc.

Enrollment

417 participants

Start Date

Apr 12, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called HC-1119 — a capsule form of a hormone-blocking medication — for men with metastatic prostate cancer whose disease has continued to grow despite having low testosterone levels (castration-resistant prostate cancer), to evaluate how well it works and how safe it is. **You may be eligible if...** - You are a male aged 18 or older - You have been diagnosed with prostate adenocarcinoma confirmed by biopsy or laboratory test - Your cancer has kept growing (PSA rising, new spots on bone scan, or growing tissue lesions) despite hormone therapy (medical or surgical castration) - Your cancer has spread to bone or other organs (confirmed by imaging) - Your testosterone level is very low (castration level) **You may NOT be eligible if...** - You have a small-cell type prostate cancer - You have not yet achieved castration-level testosterone - Your cancer has not shown confirmed progression despite treatment - You have significant health problems that would prevent you from safely participating Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHC-1119

oral

DRUGplacebo

oral


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, China

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NCT03851640


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