A Phase 2, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Niraparib in Patients With Advanced, Relapsed, High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Who Have Received Three or Four Previous Chemotherapy Regimens
Phase of Trial: Phase II
Latest Information Update: 14 Jun 2017
At a glance
- Drugs Niraparib (Primary)
- Indications Fallopian tube cancer; Ovarian cancer; Peritoneal cancer
- Focus Registrational; Therapeutic Use
- Acronyms QUADRA
- Sponsors TESARO
- 10 Jun 2017 Biomarkers information updated
- 09 Jun 2017 Planned number of patients changed from 400 to 500.
- 27 Mar 2017 According to a TESARO media release, based on the results of NOVA trial company announced the expansion and refinement of PRIMA and QUADRA trials to include a broad patient population and eliminated the enrollment requirement for a biomarker selected tumor in case of PRIMA trial.