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) - HC1119-CS-03

Hinova Pharmaceuticals (USA), Inc.0 个研究点目标入组 18 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

阶段: 3 期
状态: 招募中
发起方: Hinova Pharmaceuticals (USA), Inc.
入组人数: 18

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

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研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 64（—）

入选标准

•Subjects must meet the following 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 judgement.
•3. Ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing
•hormone (GnRH) analogue, antagonist or bilateral orchiectomy (i.e., surgical or
•castration).
•4. For patients who have not had a bilateral orchiectomy, there must be a plan
•to maintain effective GnRHanalogue or antagonist therapy for the duration of
•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 #2:
•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
•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. Eastern Cooperative Oncology Group (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., postmenopausal, 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
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排除标准

•Subjects must NOT meet any of the following 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 < 3,000/µL, or absolute 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 intervention 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 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 agent that blocks
•androgen synthesis (e.g., abiraterone) or blocks the androgen receptor (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
•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
•history of congestive heart failure NYHA class 3 or 4, unless a screening
•echocardiogram or multi-gated acquisition scan (MUGA) performed within three
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研究者

发起方

Hinova Pharmaceuticals (USA), Inc.

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