Metastatic Castration-Resistant Prostate Cancer MedDRA version: 21.1 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Hinova Pharmaceuticals (USA), Inc.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Age 18 or older and willing and able to give informed consent. 2. Histologically or cytologically confirmed adenocarcinoma of the prostate without significant and relevant neuroendocrine differentiation or small cell features, per investigator's judgment. 3. Ongoing ADT with a GnRH analogue, antagonist or bilateral orchiectomy (i.e., surgical or medical castration). 4. 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. 5. Serum testosterone level =65 years) yes F.1.3.1 Number of subjects for this age range 340
Exclusion criteria
Exclusion criteria: 1. Severe concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollment. 2. Known or suspected brain metastasis or active leptomeningeal disease. 3. Regular daily use of opiate analgesics for pain from prostate cancer within four weeks of enrollment (Day 1 visit). 4. WBC count 2.5 times the upper limit of normal at the Screening visit; no therapeutic invention within 14 days before screening. 6. Creatinine clearance < 30 mL/min as calculated using the CockcroftGault equation at the at the Screening visit. Creatinine Clearance (mL/min) = [[140-Age (years)] * Weight (kg)] / [72 * Serum Creatinine (mg/dL)]. 7. Albumin < 30 g/L (3.0 g/dL) at the Screening visit, no therapeutic invention within 14 days before screening. 8. History of another malignancy within the previous two years other than curatively treated non melanomatous skin cancer. 9. Treatment with flutamide within four weeks of enrollment (Day 1 visit). 10. Treatment with bicalutamide or nilutamide within six weeks of enrollment (Day 1 visit). 11. Treatment with 5-a reductase inhibitors (finasteride, dutasteride), estrogens, within four weeks of enrollment (Day 1 visit). 12. Treatment with systemic biologic therapy for prostate cancer (other than approved bone targeted agents) within 4 weeks of enrollment (Day 1 visit). 13. 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). 14. Prior use, or participation in a clinical trial, of an investigational agent that blocks androgen synthesis (e.g., abiraterone, galeterone, seviteronel) or blocks the AR (e.g., apalutamide, duralutamide, enzalutamide, proxalutamide). 15. Participation in a previous clinical trial of HC-1119. 16. Use of an investigational agent within four weeks of enrollment (Day 1 visit). 17. Radiation therapy for treatment of the primary tumor within three weeks of enrollment (Day 1 visit). 18. Radionuclide therapy (Radium 223) for treatment of metastasis within four weeks of enrollment (Day 1 visit). 19. Clinically significant cardiovascular disease and condition including: • Myocardial infarction within six months • Uncontrolled angina within three months • Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or patients with history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multi-gated acquisition scan (MUGA) performed within three months results in a left ventricular ejection fraction that is = 45% • History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes) • History of Mobitz II third degree heart block without a permanent pacemaker in place • Bradycardia as indicated by a heart rate of < 50 beats per minute on the Screening ECG • Patien
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy of HC 1119 as compared to enzalutamide as assessed by overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) until 24 Weeks;Secondary Objective: To determine the efficacy of HC-1119 as compared to enzalutamide as assessed by PSA50 (decline of =50% from baseline);) at 24 weeks. To determine the efficacy of HC-1119 as compared to enzalutamide as assessed by (radiographic) progression-free survival (rPFS); To determine the efficacy of HC-1119 as compared to enzalutamide as assessed by overall survival (OS); To determine the efficacy of HC-1119 as compared to enzalutamide as assessed by duration of response; To determine the efficacy of HC-1119 as compared to enzalutamide as assessed by time to prostate-specific antigen (PSA) progression; To determine the safety and tolerability of orally administered HC-1119 as compared to enzalutamide;Primary end point(s): Overall response rate by RECIST 1.1. until 24 weeks is the primary endpoint for this study.;Timepoint(s) of evaluation of this end point: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The key secondary endpoint is the proportion of patients showing a PSA decline of = 50% from baseline at Week 24. ;Timepoint(s) of evaluation of this end point: Week 24 | — |
Countries
Australia, Austria, Belgium, Canada, China, Denmark, Finland, France, Germany, Italy, Netherlands, Poland, Russian Federation, Spain, United Kingdom, United States
Contacts
Public ContactClinical Operations
Hinova Pharmaceuticals (USA), Inc.
Outcome results
None listed