Phase 2 single-arm study on the efficacy and safety of niraparib in Japanese patients with heavily pretreated, homologous recombination-deficient ovarian cancer.

ABSTRACT:

Objective

To evaluate the efficacy and safety of niraparib in Japanese women with heavily pretreated ovarian cancer.

Methods

This Phase 2 open-label, single-arm study enrolled Japanese women with homologous recombination deficiency-positive relapsed, high-grade serous ovarian, fallopian tube, or primary peritoneal cancer who had completed 3-4 lines of therapy. The starting dose of niraparib was 300 mg administered once daily in continuous 28-day cycles until objective progressive disease, unacceptable toxicity, consent withdrawal or discontinuation. The primary endpoint, objective response rate (ORR), was assessed by the investigator using RECIST version 1.1. Safety evaluations included the incidence of treatment-emergent adverse events (TEAEs), including serious TEAEs.

R

SUBMITTER: Okamoto A 

PROVIDER: S-EPMC7930437 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature