RecruitingNCT06614790

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

Patient Outcomes and Safety of Niraparib as Maintenance Treatment in Patients With Newly Diagnosed Advanced Platinum- Sensitive, Ovarian Cancer. The First Real-World Evidence Study From Poland.

Sponsor

Pomeranian Medical University Szczecin

Enrollment

300 participants

Start Date

Sep 2, 2024

Study Type

OBSERVATIONAL

Conditions

Ovarian Cancer

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).

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This real-world evidence study in Poland tracks how women with newly diagnosed advanced ovarian cancer respond to niraparib maintenance therapy — a drug taken after initial platinum chemotherapy to prevent the cancer from returning. The goal is to collect real-world data on how well this treatment works outside of controlled clinical trials. **You may be eligible if...** - You are a woman 18 years or older - You have high-grade epithelial ovarian cancer (stage III or IV) confirmed by biopsy - You have completed first-line platinum-based chemotherapy with a good response - You are eligible to receive niraparib as maintenance therapy **You may NOT be eligible if...** - You have mucinous ovarian cancer - Your cancer did not respond adequately to platinum-based chemotherapy - You have serious bone marrow, kidney, or liver problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNiraparib 200/300 MG

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

Locations(12)

Oddział Onkologii Ginekologicznej Białostockiego Centrum Onkologii

Bialystok, Poland

Klinika Położnictwa i Ginekologii, Ginekologii Onkologicznej Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

III Klinika Radioterapii i Chemioterapii Narodowego Instytutu Onkologicznego w Gliwicach

Gliwice, Poland

Świętokrzyskie Centrum Onkologii

Kielce, Poland

Klinika Ginekologii Onkologicznej Narodowego Instytutu Onkologicznego w Krakowie

Krakow, Poland

I Katedra i Klinika Ginekologii Onkologicznej i Ginekologii Uniwersytetu Medycznego w Lublinie

Lublin, Poland

Opolskie Centrum Onkologii

Opole, Poland

Oddział Onkologii Klinicznej i Radioterapii, Siedleckie Centrum Onkologii

Siedlce, Poland

Klinika Ginekologii Operacyjnej i Onkologii Ginekologicznej Dorosłych i Dziewcząt PUM

Szczecin, Poland

Klinika Ginekologii Operacyjnej i Onkologii Ginekologicznej Dorosłych i Dziewcząt PUM

Szczecin, Poland

, Klinika Ginekologii Onkologicznej, Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie w Warszawie

Warsaw, Poland

Klinika Ginekologii Onkologicznej, Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie w Warszawie

Warsaw, Poland

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