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QUADRA: Single-Arm, Open-Label, Phase 2 Trial in Serous Epithelial Ovarian, Fallopian

Tube or Primary Peritoneal Cancer

clinicaltrials.gov: NCT02354586.

Endpoint assessment

Objective response rate (ORR) per RECIST in the

fourth and fifth-line HRD

positive patients

who were PARP inhibitor naïve, and platinum sensitive.

Primary Endpoint

Niraparib

300 mg daily, 28-day cycles

Patients with histologically diagnosed, advanced, relapsed, high-grade serous epithelial

ovarian, fallopian tube, or primary peritoneal cancer who have received 3 or more previous

chemotherapy regimens

(N=461)

Moore KN, et al. J Clin Oncol 2018;36(Suppl 15):Abstract 5514

Secondary Endpoints

Durability of response, disease control rate, progression free survival (PFS), overall survival

(OS) and safety and tolerability.