A phase III randomized, placebo-controlled, double-blind study of niraparib plus abiraterone acetate and prednisone versus abiraterone acetate and prednisone in patients with metastatic prostate cancer (NCT03748641)

KN Chi; D Rathkopf; G Attard; MR Smith; E Efstathiou; D Olmos; EJ Small; JY Lee; P Sieber; C Dunshee; D Ricci; JS Simon; X Zhao; N Kothari; S Cheng; SK Sandhu

Conference Proceedings

A phase III randomized, placebo-controlled, double-blind study of niraparib plus abiraterone acetate and prednisone versus abiraterone acetate and prednisone in patients with metastatic prostate cancer (NCT03748641)

KN Chi, D Rathkopf, G Attard, MR Smith, E Efstathiou, D Olmos, EJ Small, JY Lee, P Sieber, C Dunshee, D Ricci, JS Simon, X Zhao, N Kothari, S Cheng, SK Sandhu

ANNALS OF ONCOLOGY | OXFORD UNIV PRESS | Published : 2019

DOI: 10.1093/annonc/mdz248.054

Abstract

Background Preclinical data suggest synergistic antitumor activity when a PARP inhibitor (PARPi) is combined with an androgen pathway inhibitor. The addition of a PARPi to abiraterone acetate and prednisone (AAP) shows improved radiographic progression-free survival (rPFS) versus AAP alone in patients with mCRPC regardless of the presence of DNA repair gene defects (DRD).1 Interim results from a phase 1 study2 support safety and tolerability of a combination of niraparib 200mg plus AAP in patients with mCRPC. The objective of this Phase 3 study is to compare the efficacy and safety of niraparib plus AAP versus AAP with placebo as first-line therapy for mCRPC. Trial design The multicenter glo..

View full abstract