CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 733 enrolled
Drug / intervention
Niraparib +1 moredrug
Likely dose
Niraparib dose not specified in arms or interventionsAI-extracted
Key inclusion· 6
  • ✓Histologically confirmed high-grade serous or endometrioid ovarian, fallopian tube, or primary peritoneal cancer, Stage III or IV (FIGO).
  • ✓Received 6-9 cycles of platinum-based front-line chemotherapy.
  • ✓Achieved complete response (CR) or partial response (PR) after ≥3 cycles of therapy.
  • ✓CA-125 normalized or decreased by >90% during therapy and stable for ≥7 days (increase no more than 15% from nadir).
Key exclusion· 9
  • ✕Mucinous, clear cell, carcinosarcoma, or undifferentiated ovarian cancer.
  • ✕Stage III disease with complete cytoreduction (no visible residual disease) after primary debulking surgery.
  • ✕Prior PARP inhibitor treatment or participation in a trial with PARP inhibitor arm.
  • ✕Planned bevacizumab maintenance treatment.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02655016
NCT02655016Phase 3Active
CompareCT.gov

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

Tesaro, Inc.·interventional·Posted Jan 13, 2016·Updated Mar 10, 2026

In Brief

A Phase 3 clinical trial evaluating Niraparib and Placebo for Ovarian Neoplasms. Active but no longer recruiting, targeting 733 participants across 116 sites in 14 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian Neoplasms
CountriesBelgium, Denmark, Finland, France, Germany, Ireland, Israel, Italy, Norway, Spain, Sweden, Switzerland, United Kingdom, United States
CollaboratorsGynecologic Oncology Group, European Network of Gynaecological Oncological Trial Groups (ENGOT), Myriad Genetics, Inc.

Timeline

Phase 3ActiveOverdue
20162017201820192020202120222023202420252026
First PostedJan 13, 2016
Enrollment StartJul 11, 2016
Primary CompletionMay 17, 2019
Study CompletionMay 29, 2026
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 10.5 years ago

Interventions

Niraparibdrug

Niraparib will be administered.

Placebodrug

Placebo will be administered.