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NIRAPARIB TOSILATE MONOHYDRATE

DRUG2 trials

Sponsors

Nord Ostdeutsche Gesellschaft Fuer Gynaekologische Onkologie e.V., Tesaro Inc.

Conditions

Homologous recombination deficiency advanced ovarian cancerIIIBIIICadvanced (FIGO stage IIIAfallopian tube canceror IV of the 2014 FIGO classification) HRDpositive high-grade ovarian cancerprimary peritoneal cancer and clear cell carcinoma of the ovary with no residual tumor mass following primary tumor debulking

Phase 2

A Phase II randomized, open label non-inferiority study of NiraParib maintenance after 3 vs. 6 cycles of platinum-based chemotherapy in completeLy debUlked advanced HRDpositive high-grade ovarian cancer patientS in first line therapy
RecruitingCTIS2022-502559-69-01
Nord Ostdeutsche Gesellschaft Fuer Gynaekologische Onkologie e.V.advanced (FIGO stage IIIA, fallopian tube cancer, IIIB +3
Start: 2024-07-04Target: 640Updated: 2025-08-22

Phase 3

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients with Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
CompletedCTIS2023-508010-42-00
Tesaro Inc.Homologous recombination deficiency advanced ovarian cancer
Start: 2016-09-14End: 2025-09-30Target: 469Updated: 2025-10-13