PROCADE: A Multinational Phase 3, Randomized, Double-Blind, Non-Inferiority, Efficacy and Safety Study of Oral HC-1119 versus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC) - PROCADE

Hinova Pharmaceuticals (USA) Inc.0 个研究点目标入组 430 人开始时间: 2019年10月30日最近更新: 2024年8月12日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Hinova Pharmaceuticals (USA) Inc.
入组人数: 430

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: Male

入选标准

•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 < 1.7 nmol/L (50 ng/dL) at the Screening visit.
•6. Patients receiving bisphosphonate or denosumab therapy must have been on stable doses for at least four weeks (from Day 1 visit).
•7. 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:
•a. 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)
•b. Soft tissue disease progression defined by RECIST 1.1
•c. Bone disease progression defined by PCWG3 with two or more new lesions on bone scan
•8. 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.
•9. No prior cytotoxic chemotherapy for prostate cancer.
•10. Asymptomatic or mildly symptomatic from prostate cancer.
•11. ECOG performance status of 0–1 per the Investigators’ clinical assessment
•12. Estimated life expectancy of = 6 months
•13. Able to swallow the study drug and comply with study requirements
•14. All sexually active patients are required to use a condom as well as meet 1 of the following:
•a. Patient is non-fertile (orchiectomy) or has a female partner of non-childbearing potential (i.e., post-menopausal, surgically sterilized, hysterectomy)
•b. Patient and his female partner use 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.
•15.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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 90
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 340

排除标准

•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 < 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).
•5. 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.
•6. Creatinine clearance < 30 mL/min as calculated using the Cockcroft-Gault 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 four 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 agent that blocks androgen synthesis (e.g., abiraterone) or blocks the AR (e.g., apalutamide, darolutamide, 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 or 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 with history of congestive heart failure NYHA class 3 or 4, 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
•Patients with manifest hypertension at the Screening visit

研究者

发起方

Hinova Pharmaceuticals (USA) Inc.

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