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: 12 Oct 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

    • 12 Oct 2017 Results of pooled data assessing indirect treatment comparison (ITC) of niraparib tablets and olaparib capsules in patient with platinum-sensitive relapsed serous ovarian cancer after previous platinum-based chemotherapy from two trial (NOVA and study19), were presented at the 20th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research.
    • 12 Oct 2017 Results of indirect treatment comparison between olaparib tablets and niraparib tablets from two trial (NOVA and SOLO2), were presented at the 20th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research.
    • 15 Sep 2017 According to a TESARO media release, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the Company's marketing authorization application (MAA) 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 a complete response (CR) or partial response (PR) to platinum-based
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