Overview

Niraparib Versus Niraparib-bevacizumab Combination in Women With Platinum-sensitive Epithelial Ovarian Cancer

Status:
Active, not recruiting

Trial end date:
2022-12-15

Target enrollment:

Participant gender:

Summary

Part 1 (Phase 1): safety and tolerability of bevacizumab-Niraparib combination Part 2 (Randomized Phase 2): to compare Progression-Free Survival (PFS) PARP inhibitors are active as monotherapy to treat patients with recurrent ovarian cancer; the strongest activity being observed in the platinum sensitive, gBRCAmut subgroup as well as in gBRCAwt, HRD population but also in HRD negative disease. In the same population there is level one evidence that bevacizumab is beneficial. And a phase two randomized study has indicated that combination of a PARP inhibitor with anti-angiogenic drug is superior to PARP inhibitor alone. The question is: Is niraparib combined with bevacizumab superior to niraparib? The comparison of tolerability and efficacy of niraparib-bevacizumab combination against niraparib.

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

Nordic Society for Gynaecologic Oncology
Nordic Society of Gynaecological Oncology - Clinical Trials Unit

Collaborators:

Dana-Farber Cancer Institute
ENGOT
European Network of Gynaecological Oncological Trial Groups (ENGOT)
GCIG
Gynecologic Cancer Intergroup (GCIG)
Massachusetts General Hospital
Myriad Genetics, Inc.
University of Utah

Treatments:

Bevacizumab
Niraparib