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

Janssen-Cilag International N.V.0 个研究点目标入组 1,000 人开始时间: 2018年11月30日最近更新: 2024年4月8日

适应症

试验速览

暂无简介。

•1. DRD status (identified by the sponsor’s required assays)
•2. Metastatic disease documented by radiographic imaging
•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. Adequate clinical laboratory values at Screening
•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 300
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 700

•1. Prior treatment with a PARP inhibitor
•2. No prior systemic therapy for mCRPC except for GnRHa and limited AA-P
•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
•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) per day
•11. History of adrenal dysfunction
•13. Subjects who are receiving opioid analgesics at the time of screening
•14. Active human immunodeficiency virus (HIV) infection

发起方