Clinical Trials Directory

Trials / Terminated

TerminatedNCT06964165

A Study Comparing Niraparib Versus Platinum-Taxane Doublet Chemotherapy as Neoadjuvant Treatment in Participants With Homologous Recombination-Deficient Stage III/IV Ovarian Cancer (COHORT-C)

Cohort C: Open-label Phase 2, Randomized, Controlled Multicenter Study Comparing Niraparib Versus Platinum-Taxane Doublet Chemotherapy as Neoadjuvant Treatment in Participants With Homologous Recombination-Deficient Stage III/IV Ovarian Cancer

Status
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
36 (actual)
Sponsor
Tesaro, Inc. · Industry
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

The goal of the study is to learn whether Niraparib or Platinum-Taxane Doublet chemotherapy is better in treating participants with Homologous Recombination Deficient (HRd) Stage III/IV Ovarian Cancer (OC). This study is a sub-study of the Master protocol -OPAL (NCT03574779)

Conditions

Interventions

TypeNameDescription
DRUGNiraparibNiraparib will be administered
DRUGCarboplatinCarboplatin will be administered
DRUGPaclitaxelPaclitaxel will be administered

Timeline

Start date
2022-04-14
Primary completion
2024-06-28
Completion
2025-03-31
First posted
2025-05-09
Last updated
2025-11-26
Results posted
2025-07-15

Locations

21 sites across 3 countries: United States, Canada, Spain

Regulatory

Source: ClinicalTrials.gov record NCT06964165. Inclusion in this directory is not an endorsement.