EUCTR2017-003364-12-CZ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
- 1,000
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
入选标准
- •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
排除标准
- •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
研究者
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