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.1 site in 1 country417 target enrollmentApril 12, 2019

ConditionsMCRPC

InterventionsHC-1119 placebo

DrugsHC-1119 placebo

Overview

Phase: Phase 3
Intervention: HC-1119
Conditions: MCRPC
Sponsor: Hinova Pharmaceuticals Inc.
Enrollment: 417
Locations: 1
Primary Endpoint: Radiographic Progression-Free Survival (rPFS)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

April 12, 2019

End Date

September 2025

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

Male

Investigators

Sponsor

Hinova Pharmaceuticals Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion 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 determined according to the PCWG3 criteria, defined as satisfying one or more of the following 3 criteria:
•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;
•Progression of soft tissue lesions as defined by RECIST 1.1;
•The progression of bone lesions is defined as at least two new lesions discovered by bone scan; ambiguous results can be confirmed using another imaging technique (e.g., CT or MRI).
•Metastatic diseases confirmed by imaging examinations during the screening period (the status of metastasis refers to the presence of metastatic lesions confirmed by bone scan and/or CT/MRI scan).
•For patients who have undergone orchiectomy or are being treated by medical castration therapy, their androgen blockade therapy is maintained by luteinizing hormone-releasing hormone agonists or antagonists during the study period (including the follow-up period), and their serum testosterone levels are ≤ 1.73 nmol/L (50 ng/dL) during screening visits.
•Patients who have failed previous treatments of prostate cancer with abiraterone acetate or who are intolerant to treatments with abiraterone acetate.
•Patients who have failed previous chemotherapy of prostate cancer with docetaxel or who are intolerant to treatments with docetaxel, or who are not suitable for docetaxel treatment during screening. Patients who are not suitable for docetaxel treatment during screening and do not plan to use cytotoxic chemotherapy within 6 months after the informed discussion are eligible.

Exclusion Criteria

•Subjects with any of the following conditions should not be enrolled:
•Received any anti-prostate cancer treatment within 4 weeks before randomization, including chemotherapy, immunotherapy, targeted therapy, estrogen therapy, anti-androgen therapy, systemic radiotherapy, treatments with traditional Chinese medicines for anticancer, or treatments with interventional drugs of other clinical trials; palliative radiotherapy or surgery for bone metastatic or soft tissue lesions should be completed \>14 days prior to baseline imaging examinations; the lesions treated by palliative radiotherapy should not be the targeted lesions of subsequent RECIST 1.1 assessment. Androgen blockade therapy that is maintained by a luteinizing hormone releasing hormone agonist or antagonist.
•Previously received any of novel androgen receptor inhibitors (e.g., Enzalutamide, Apalutamide, Darolutamide, SHR3680, Proxalutamide, or HC-1119).
•Patients with brain or central nervous system metastases are known (if a brain or central nervous system metastasis is suspected, a CT/MRI scan of the head is required)
•Patients with known serious cardiovascular diseases, including any of the following:
•A myocardial infarction or thrombotic event occurred in the past 6 months;
•Known unstable angina;
•Heart failure of Grade III or IV according to the New York Heart Association (NYHA) criteria;
•QT interval of \> 500 ms during screening visits;
•Resting systolic blood pressure of \>170 mmHg or diastolic blood pressure of \>105 mmHg suggesting uncontrolled hypertension during screening visits.

Arms & Interventions

HC-1119

80mg;

Intervention: HC-1119

placebo

80mg;

Intervention: placebo

Outcomes

Primary Outcomes

Radiographic Progression-Free Survival (rPFS)

Time Frame: From signing informed consent up to approximately 30 months

Secondary Outcomes

Overall Survival (OS)(From signing informed consent up to approximately 30 months)
Time to progression (TTP)(From signing informed consent up to approximately 30 months)
Objective response rate (ORR)(From signing informed consent up to approximately 30 months)
Disease control rate (DCR)(From signing informed consent up to approximately 30 months)
Response rate of prostate specific antigen (PSA)(From signing informed consent up to approximately 30 months)
Time to prostate specific antigen(PSA) progression (TTPP)(From signing informed consent up to approximately 30 months)
Number of patients with adverse events(From signing informed consent up to approximately 30 months)