Status:
TERMINATED
HC-1119 Versus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Lead Sponsor:
Hinova Pharmaceuticals USA, Inc.
Conditions:
Prostate Cancer Metastatic
Castration-resistant Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
This study is a multinational Phase 3, randomized, double-blind, non-inferiority, efficacy and safety study of oral HC-1119 (80 mg/day) versus enzalutamide (160 mg/day) in asymptomatic or mildly sympt...
Detailed Description
This study is a multinational Phase 3, randomized, double-blind, non-inferiority, efficacy and safety study of oral HC-1119 (80 mg/day) versus enzalutamide (160 mg/day) in asymptomatic or mildly sympt...
Eligibility Criteria
Inclusion
- Subjects must meet the following inclusion criteria:
- Age 18 or older and willing and able to give informed consent.
- Histologically or cytologically confirmed adenocarcinoma of the prostate without significant and relevant neuroendocrine differentiation or small cell features, per investigator's judgment.
- Ongoing ADT with a GnRH analogue, antagonist or bilateral orchiectomy (i.e., surgical or medical castration).
- For patients who have not had a bilateral orchiectomy, there must be a plan to maintain effective GnRH analogue or antagonist therapy for the duration of the trial.
- Serum testosterone level \< 1.7 nmol/L (50 ng/dL) at the Screening visit.
- Patients receiving bisphosphonate or denosumab therapy must have been on stable doses for at least four weeks (from Day 1 visit).
- Progressive disease at study entry defined as one or more of the following three criteria that occurred while the patient was on ADT as defined in eligibility criterion #3:
- PSA progression defined by a minimum of two rising PSA levels with an interval of ≥ 1 week between each determination. Patients who received an anti-androgen agent must have progression after withdrawal (≥ 4 weeks since last flutamide or ≥ 6 weeks since last bicalutamide or nilutamide). The PSA value at the Screening visit should be ≥ 2 µg/L (2 ng/mL)
- Soft tissue disease progression defined by RECIST 1.1
- Bone disease progression defined by PCWG3 with two or more new lesions on bone scan
- Metastatic disease documented by measurable soft tissue disease by CT/MRI per RECIST 1.1 criteria. Patients are allowed to have any metastatic disease (i.e. bone metastasis) as long as they also have measurable soft tissue lesions per RECIST 1.1..
- No prior cytotoxic chemotherapy for prostate cancer.
- Asymptomatic or mildly symptomatic from prostate cancer.
- ECOG performance status of 0-1 per the Investigators' clinical assessment
- Estimated life expectancy of ≥ 6 months
- Able to swallow the study drug and comply with study requirements
- All sexually active patients are required to use a condom as well as meet 1 of the following:
- Patient is non-fertile (orchiectomy) or has a female partner of non-childbearing potential (i.e., post-menopausal, surgically sterilized, hysterectomy)
- Patient and his female partner must agree to use an adequate contraceptive method from the first day of dosing until 3 months after the last dose to prevent pregnancies. Adequate contraceptive method is defined as:
- i. Established use of oral, injected, or implanted hormonal methods of contraception.
- ii. Placement of an intra-uterine device or intra-uterine system. iii. Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
- iv. Tubal ligation for at least 6 months prior to screening.
- Male patient engaged in sexual activity with a pregnant female is required to use a condom from the first day of dosing until 3 months after the last dose of treatment with study drugs.
Exclusion
- Subjects must NOT meet any of the following exclusion criteria:
- Severe concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollment.
- Known or suspected brain metastasis or active leptomeningeal disease.
- Regular daily use of opiate analgesics for pain from prostate cancer within four weeks of enrollment (Day 1 visit).
- WBC count \< 3,000/µL, or absolute neutrophil count \< 1,500/µL, or platelet count \< 100,000/µL, or hemoglobin \< 5.6 mmol/L (9 g/dL) at the Screening visit (NOTE: patients may not have received any growth factors or blood transfusions or any therapeutic invention within 14 days of the hematologic laboratory values obtained at the Screening visit).
- Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.5 times the upper limit of normal at the Screening visit; no therapeutic invention within 14 days before screening.
- Creatinine clearance \< 30 mL/min as calculated using the Cockcroft-Gault equation at the Screening visit. Creatinine Clearance (mL/min) = \[\[140-Age (years)\] \* Weight (kg)\] / \[72 \* Serum Creatinine (mg/dL)\]
- Albumin \< 30 g/L (3.0 g/dL) at the Screening visit, no therapeutic invention within 14 days before screening.
- History of another malignancy within the previous two years other than curatively treated non-melanomatous skin cancer.
- Treatment with flutamide within four weeks of enrollment (Day 1 visit).
- Treatment with bicalutamide or nilutamide within six weeks of enrollment (Day 1 visit).
- Treatment with 5-α reductase inhibitors (finasteride, dutasteride), estrogens within four weeks of enrollment (Day 1 visit).
- Treatment with systemic biologic therapy for prostate cancer (other than approved bone targeted agents) within four weeks of enrollment (Day 1 visit).
- Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids greater than the equivalent of 10 mg of prednisone/prednisolone per day within four weeks of enrollment (Day 1 visit).
- Prior use, or participation in a clinical trial, of an agent that blocks androgen synthesis (e.g., abiraterone) or blocks the AR (e.g., apalutamide, darolutamide, enzalutamide, proxalutamide).
- Participation in a previous clinical trial of HC-1119.
- Use of an investigational agent within four weeks of enrollment (Day 1 visit).
- Radiation therapy for treatment of the primary tumor within three weeks of enrollment (Day 1 visit).
- Radionuclide therapy (Radium 223) for treatment of metastasis within four weeks of enrollment (Day 1 visit).
- Clinically significant cardiovascular disease or condition
- Treatment with strong CYP2C8 inhibitors and inducers, CYP3A4 inducers, medications which are known to prolong the QT interval (see Appendix C).
- History of seizure or any condition that may predispose to seizure.
- Conditions that predispose subjects to increased risk for falls or fractures according to the discretion of the Investigator.
- Gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer disease within last three months).
- Major surgery within four weeks prior to enrollment (Day 1 visit).
- Have active infection with HBV measured by hepatitis B surface antigen (HBsAg) test, HCV measured by RNA test and HIV measured by antibody test.
- Have known active tuberculosis.
- Known hypersensitivity to HC-1119, enzalutamide, or any of the excipients.
- Rare hereditary problems of fructose intolerance due to sorbitol
Key Trial Info
Start Date :
March 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2024
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT03850795
Start Date
March 15 2021
End Date
June 28 2024
Last Update
August 19 2024
Active Locations (58)
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1
Urology Center of Colorado, 2777 Mile High Stadium Circle
Denver, Colorado, United States, 80211
2
Urologic Surgeons of Washington
Washington D.C., District of Columbia, United States, 20036
3
First Urology PSC, 101 Hospital Boulevard
Jeffersonville, Indiana, United States, 47130
4
Clinical Research Solutions PC
Middleburg Heights, Ohio, United States, 44130