EUCTR2017-003364-12-GB进行中（未招募）1 期
A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Subjects with Metastatic Prostate Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,100
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. Criterion modified per Amendment 3
- •1.1 Criterion modified per Amendment 4
- •1.2 HRR gene alteration status (as identified by the sponsor's required assays or local testing for HRR gene alteration) as follows:
- •a. Cohort 1: positive for HRR gene alteration
- •b. Cohort 2: not positive for HRR gene alteration (ie, no HRR gene alteration)
- •c. Cohort 3
- •2. Metastatic disease documented by positive bone scan or metastatic lesions on computed tomography (CT) or magnetic resonance imaging (MRI).
- •3. Criterion modified per Amendment 2
- •3.1 Metastatic prostate cancer in the setting of castrate levels of testosterone =50 ng/dL on a GnRHa or bilateral orchiectomy as evidenced by prostate-specific antigen (PSA) progression or radiographic progression
- •4. Able to continue GnRHa during the study if not surgically castrate
- •5. ECOG PS Grade of 0 or 1
- •6. Score of =3 on the Brief Pain Inventory-Short Form (BPI-SF) Question #3 (worst pain in last 24 hours).
- •7. Criterion modified per Amendment 2
- •7.1 Clinical laboratory values at Screening:
- •a .Absolute neutrophil count (ANC) =1.5 x 10^9/L.
- •b. Hemoglobin =9.0 g/dL, independent of transfusions for at least 30 days.
- •c. Platelet count =100 x 10^9/L.
- •d. Serum albumin =3.0 g/dL.
- •e. Creatinine clearance =30 mL/min either calculated or directly measured via 24-hour urine collection.
- •f. Serum potassium =3.5 mmol/L.
- •g. Serum total bilirubin =1.5 x upper limit of normal (ULN) or direct bilirubin =1 x ULN (Note: in subjects with Gilbert's syndrome, if total bilirubin is >1.5 x ULN, measure direct and indirect bilirubin, and if direct bilirubin is =1.5 x ULN, subject may be eligible as determined by the medical monitor).
- •h. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =3 x ULN.
- •8. Able to swallow the study drug tablets and capsules whole.
- •9. To avoid risk of drug exposure through the ejaculate (even men with vasectomies), subjects must agree while on study drug and for 3 months following the last dose of study drug to:
- •a. Use a condom during sexual activity.
- •b. Not donate sperm.
- •10. Willing and able to adhere to the prohibitions and restrictions specified in the protocol
- •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 260
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 840
排除标准
- •1. Prior treatment with a PARP inhibitor
- •2. Criterion modified per Amendment 2
- •2.1 Systemic therapy (ie, novel second-generation AR-targeted therapy such as enzalutamide, apalutamide, or darolutamide; taxane-based chemotherapy, or more than 4 months of AA-P prior to randomization) in the mCRPC setting; or AA-P outside of the mCRPC setting.
- •3. Criterion modified per Amendment 2
- •3.1 For subjects who received 2 to 4 months of AA-P prior to randomization for the treatment of mCRPC, evidence of progression by PSA (per PCWG3) during screening. These potential subjects are required to have 2 PSA values during the Prescreening and Screening Phases. The second PSA value should be within 2 weeks of randomization. If PSA rise is thought to be due to flare, the investigator
- •should confirm that there is no radiographic progression.
- •4. Symptomatic brain metastases
- •5. History or current diagnosis of myelodysplastic syndrome (MDS)/acute
- •myeloid leukemia (AML)
- •6. Other prior malignancy =2 years prior to randomization, or malignancy that currently requires active systemic therapy
- •7. Severe or unstable angina, myocardial infarction or ischemia requiring coronary artery bypass graft or stent within the previous 6 months, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g. adequate cardiac function), or clinically significant ventricular arrhythmias within 6 months prior to randomization or New York Heart Association (NYHA) Class II to IV heart disease
- •8. Presence of uncontrolled hypertension. Subjects with a history of hypertension are allowed, if BP is controlled to within these limits by anti-hypertensive treatment.
- •9. Current evidence of any of the following:
- •a. Any medical condition that would make prednisone use contraindicated
- •b. Any chronic medical condition requiring a higher equivalent dose of corticosteroid than 10 mg prednisone (or equivalent) once daily.
- •10. Active or symptomatic viral hepatitis or chronic liver disease (as evidenced by ascites or bleeding disorders secondary to hepatic dysfunction).
- •11. History of adrenal dysfunction
- •12. Known allergies, hypersensitivity, or intolerance to AA or niraparib or the corresponding excipients
- •13. Subjects who are receiving opioid analgesics at the time of screening
- •14. Human immunodeficiency virus (HIV) positive subjects with 1 or more of the following:
- •a. Not receiving highly active antiretroviral therapy.
- •b. Receiving antiretroviral therapy that may interfere with the study drug
- •c. A change in antiretroviral therapy within 6 months of the start of screening
- •d. CD4 count <350 at screening.
- •e. An acquired immunodeficiency syndrome-defining opportunistic infection within 6 months of the start of screening.
- •15. Subjects who have had the following =28 days prior to randomization:
- •a. A transfusion (platelets or red blood cells).
- •b. Hematopoietic growth factors.
- •c. An investigational agent for prostate cancer.
- •d. Major surgery (sponsor should be consulted regarding what constitutes major surgery).
- •e. Radiation therapy
研究者
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