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

Trial Profile

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

Recruiting
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
  • Most Recent Events

    • 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.
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