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

Sponsor
Pomeranian Medical University Szczecin
Study ID
NCT06614790
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Niraparib 200/300 MG — DRUG
    We expect to enroll approximately 300 patients from about 10 sites. Treatment part of study. Part I- looking retrospectively at the time period JAN 2021-MAR 2023. The retrospective data will include patients who are enrolled in niraparib treatment: * under the EAP (started in JAN 2021, in continuation) * under the B.50 drug program, which began in January 2022 Of note, the retrospective multi-center observational study will involve about 30 patients treated with niraparib in EAP (FIGO III R0 after PDS included) and patients who were treated with niraparib before starting RWE (about 120 pts) (JAN 2021- MAR 2023) by the drug program B.50 which has been started to adapt on 1st of Jan, 2022. FIGO III PDS to R0 patients are included to this study. Part II- looking prospectively at the time period APR 2023 to DEC 2025. The prospective data will include patients who are enrolled in niraparib treatment under the B.50 drug program. The prospective multi-center observational study will i

Study Details

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).

Key Dates

Start date
Sep 2, 2024
Status verified
Oct 2024
Primary completion
Dec 30, 2025
Completion
Jan 7, 2026

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: Patients with advanced, high-grade ovarian cancer who respond on the first line therapy (NED, CR,PR)

Primary Outcome Measure

Safety and tolerability. [ Time Frame: 27 months ]

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