A Phase 3 Randomized Double-blind Trial of Maintenance With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer.

Trial Profile

A Phase 3 Randomized Double-blind Trial of Maintenance With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer.

Completed
Phase of Trial: Phase III

Latest Information Update: 23 Nov 2017

At a glance

  • Drugs Niraparib (Primary)
  • Indications Fallopian tube cancer; Ovarian cancer; Peritoneal cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms NOVA
  • Sponsors TESARO
  • Most Recent Events

    • 20 Nov 2017 Results presented in a TESARO Media Release.
    • 20 Nov 2017 According to a TESARO media release, based on the data from this study, European Commission (EC) has granted marketing authorization for ZEJULA (niraparib) as a monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete response (CR) or partial response (PR) to platinum-based chemotherapy.
    • 12 Oct 2017 Results of indirect treatment comparison (ITC) of niraparib tablets and olaparib capsules from two trial (NOVA and study19), were presented at the 20th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research.
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