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A Study of Niraparib (GSK3985771) Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

NCT02655016 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 733

Last updated 2026-03-10

Study results available
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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.

Conditions

  • Ovarian Neoplasms

Interventions

DRUG

Niraparib

Niraparib will be administered.

DRUG

Placebo

Placebo will be administered.

Sponsors & Collaborators

  • Gynecologic Oncology Group

    collaborator NETWORK

  • European Network of Gynaecological Oncological Trial Groups (ENGOT)

    collaborator OTHER

  • Myriad Genetics, Inc.

    collaborator INDUSTRY

  • Tesaro, Inc.

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-11
Primary Completion
2019-05-17
Completion
2026-05-29
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Denmark
  • Finland
  • France
  • Germany
  • Ireland
  • Israel
  • Italy
  • Norway
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02655016 on ClinicalTrials.gov