clinical trial · NCT04691804
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.·phase3·active not recruiting·n = 496
Metastatic Castration-Resistant Prostate Cancer (mCRPC)Fuzuloparib , Abiraterone acetate and PrednisoneFuzuloparib Placebo, Abiraterone acetate and Prednisone
brief summary
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).
started
Mar 18, 2021
primary completion
Dec 31, 2026
completion
Dec 31, 2026
last updated
Dec 31, 2024
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol