A Study of Niraparib Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

Official Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicentre Study of Niraparib Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

Summary:

This study is a double-blind, randomized, placebo-controlled (2:1 niraparib:placebo) study in patients with Stage III or IV ovarian cancer. Patients must have completed front-line platinum based regimen with a physician-assessed response of Complete Response (CR) or Partial Response (PR). Additionally, patients must have a normal or >90% decrease in cancer antigen 125 (CA-125) following front-line platinum treatment. The study will assess the efficacy of niraparib as maintenance treatment, as measured by PFS.

Trial Description

Primary Outcome:

  • Progression Free Survival
Secondary Outcome:
  • Overall Survival
  • Safety and tolerability of Niraparib versus Placebo as Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
  • Patient Reported Outcomes (PROs)
  • Time to progression on the next anticancer therapy (PFS2)

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society