Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Lee-May Chen

Description

Summary

This study aims to assess efficacy of Niraparib (GSK3985771) as maintenance treatment in participants with Stage III or IV ovarian cancer. Participants must have completed front-line platinum based regimen with complete response (CR) or partial response (PR). Data collection for Secondary Outcome measures is ongoing and the approximate duration of the study will be 7 years.

Official Title

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

Keywords

Ovarian Neoplasms, Ovarian Cancer, Niraparib, GSK3985771, Poly(adenosine diphosphate [ADP]-ribose) polymerase (PARP)Inhibitor, Homologous recombination deficiency (HRD), HRD positive, PRIMA, PRIMA Clinical Trial, PRIMA Study, Ovarian Epithelial Carcinoma

Eligibility

Locations

  • GSK Investigational Site
    San Francisco California 94115 United States
  • GSK Investigational Site
    San Francisco California 94118 United States

Lead Scientist at UCSF

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Tesaro, Inc.
ID
NCT02655016
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 733 people participating
Last Updated