跳至主要内容
临床试验/NCT04691804
NCT04691804进行中(未招募)3 期

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study of Fuzuloparib Combined With Abiraterone Acetate and Prednisone (AA-P) Versus Placebo Combined With AA-P as First-Line Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer

Jiangsu HengRui Medicine Co., Ltd.147 个研究点 分布在 4 个国家目标入组 496 人开始时间: 2021年3月18日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
进行中(未招募)
入组人数
496
试验地点
147
主要终点
rPFS by blinded independent central review (BICR) using RESIST1.1 and PCWG3

研究概览

简要总结

To evaluate whether Fuzuloparib plus AA-P is superior to placebo plus AA-P as first-line treatment by assessment of radiographic progression-free survival (rPFS) in mCRPC subjects unselected for deoxyribonucleic acid (DNA) damage repair deficiencies (DRD) status (Cohort 1) to evaluate whether Fuzuloparib plus AA-P is superior to placebo plus AA-P as first-line treatment by assessment of rPFS in mCRPC subjects harboring DRD (Cohort 2).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Treatment group A

Experimental

Fuzuloparib plus AA-P

干预措施: Fuzuloparib , Abiraterone acetate and Prednisone (Drug)

Treatment group B

Placebo Comparator

Fuzuloparib Placebo plus AA-P

干预措施: Fuzuloparib Placebo, Abiraterone acetate and Prednisone (Drug)

结局指标

主要结局

rPFS by blinded independent central review (BICR) using RESIST1.1 and PCWG3

时间窗: up to 3 years

progression-free survival

次要结局

  • ORR(up to 3 years)
  • Time to PSA progression(up to 3 years)
  • OS(up to 4 years)
  • Time to skeletal-related events(up to 4 years)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (147)

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