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 - Magnitude

Janssen-Cilag0 个研究点目标入组 11 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

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•1. Histologically confirmed metastatic prostate cancer with no prior systemic
•therapy in the
•mCRPC setting
•2. Can provide blood sample for determination of HRR
•3. Willing to provide a fresh or archival tumor tissue sample for determination
•4. HRR status (as identified by the sponsor*s required assays or positive BRCA1
•or BRCA2 germline testing results from certified laboratories as acceptable for
•screening.) as follows:
•a. Cohort 1: positive for HRR (per protocol amendment 3: stop enrollment of
•subjects with ATM mutations into Cohort 1 and to ensure at least 50% of Cohort
•1 are subjects with BRCA mutations)
•b. Cohort 2: not positive for HRR (ie, no HRR)
•c. Cohort 3: positive or not positive for HRR gene alterations
•5. Must be able to continue GnRHa during the study if not surgically castrate
•6. ECOG PS grade of 0 or 1
•7. Adequate hematologic and metabolic values at screening

•1. Prior treatment with a PARP inhibitor
•2.Systemic therapy in the mCRPC setting; or AA-P outside of the mCRPC setting.
•3.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
•4.. Severe or unstable angina, myocardial infarction, symptomatic congestive
•heart failure,
•arterial or venous thromboembolic events (e.g, pulmonary embolism,
•cerebrovascular
•accident including transient ischemic attacks), or clinically significant
•ventricular
•arrhythmias within 6 months prior to randomization or New York Heart Association
•(NYHA) Class II to IV heart disease.
•5.. Presence of uncontrolled hypertension (systolic blood pressure [BP] >160
•diastolic BP >100 mmHg). Subjects with a history of hypertension are allowed,
•that BP is controlled to within these limits by anti-hypertensive treatment.
•6. Active or symptomatic viral hepatitis or chronic liver disease (as evidenced
•by ascites or
•bleeding disorders secondary to hepatic dysfunction)
•7. Subjects who have had the following <=30 days prior to planned Cycle 1 Day 1:
•a. a transfusion (platelets or red blood cells)
•b. hematopoietic growth factors
•c. an investigational agent for prostate cancer
•d. major surgery
•e. radiation therapy

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