Clinical Trial

Niraparib Maintenance Treatment in Patients With Newly Diagnosed Advanced Platinum- Sensitive, OC. The First Poland RWE Study.

Study acronym: NIRAPARIB

Recruiting

Record status

This record was last updated October 23, 2024 (before its estimated December 30, 2025 completion). Its status may not reflect the trial's current state.

Summary

The study is observational, not interventional. The study will include patients with advanced ovarian cancer who have been treated in Poland based on a previous early access program, and who are currently being treated under the B.50 drug program, funded by the National Health Fund. Only patients currently being treated in the B.50 program at 10 selected centers listed on this site may be included in the study. Of course, any patient in Poland eligible for maintenance treatment with niraparib can receive the drug, regardless of participation in this RWE study.The treatment involves administering niraparib as maintenance therapy for 3 years after the completion of chemotherapy, provided that the patient has responded to systemic treatment (NED, CR, PR).

Protocol Amendment History 1 amendment

This ClinicalTrials.gov record has been amended once since 2024-09-23.

Status change: Not Yet Recruiting → Recruiting 2024-10-22

Trial Details

NCT Number	NCT06614790
Lead Sponsor	Pomeranian Medical University Szczecin
Conditions	Ovarian Cancer
Enrollment	300 participants
Start Date	2024-09-02
Primary Completion	2025-12-30 (estimated)
Study Completion	2026-01-07 (estimated)
Updated on ClinicalTrials.gov	2024-10-23