A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer

3상 진행 중(모집 완료) NCT03748641

대상 질환	Castration-Resistant Prostatic Cancer
임상 단계	3상
스폰서	Janssen Research & Development, LLC
상태	진행 중(모집 완료)
참여자 수	765 명
중재(약물)	Niraparib, Abiraterone Acetate, Prednisone, New Formulation of Niraparib and Abiraterone Acetate (AA)
시작일	2019년 1월 25일
완료일	2021년 10월 8일
결과 공개일	2023년 10월 4일

요약

The purpose of this study is to evaluate the effectiveness of niraparib in combination with abiraterone acetate plus prednisone (AAP) compared to AAP and placebo.

Cohort 1: Radiographic Progression-Free Survival (rPFS) as Assessed by Blinded Independent Central Review (BICR)

Up to 32 months · Months

Cohort 1: Niraparib 200 mg + Abiraterone Acetate 1000 mg + Prednisone 10 mg	16.46 Months
Cohort 1: Placebo + Abiraterone Acetate 1000 mg + Prednisone 10 mg	13.70 Months

p-value	0.0217
Hazard Ratio (HR)	0.729 (95% CI 0.556–0.956)

Cohort 1 Breast Cancer Gene (BRCA) Subgroup: Radiographic Progression-Free Survival (rPFS) as Assessed by Blinded Independent Central Review (BICR)

Up to 32 months · Months

Cohort 1 BRCA Subgroup: Niraparib 200 mg + Abiraterone Acetate 1000 mg + Prednisone 10 mg	16.56 Months
Cohort 1 BRCA Subgroup: Placebo + Abiraterone Acetate 1000 mg + Prednisone 10 mg	10.87 Months

p-value	0.0014
Hazard Ratio (HR)	0.533 (95% CI 0.361–0.789)

BENITIONS에서 보기 ClinicalTrials.gov 원문 보기

같은 질환의 다른 임상

A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate — Aragon Pharmaceuticals, Inc.
Propranolol Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery — Wake Forest University Health Sciences
Testing the Safety of Different Doses of Olaparib Given Radium-223 for Men With Advanced P — National Cancer Institute (NCI)
M6620 and Carboplatin With or Without Docetaxel in Treating Patients With Metastatic Castr — National Cancer Institute (NCI)
Testing Two Oral Drugs Combination (Cediranib and Olaparib) Compared to a Single Drug (Ola — National Cancer Institute (NCI)
A Study of Apalutamide in Chinese Participants With Non Metastatic Castration Resistant Pr — Janssen Research & Development, LLC

전체 임상

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