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Niraparib Maintenance Treatment in Patients With Newly Diagnosed Advanced Platinum- Sensitive, OC. The First Poland RWE Study.
Sponsor: Pomeranian Medical University Szczecin
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).
Official title: 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.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
300
Start Date
2024-09-02
Completion Date
2026-01-07
Last Updated
2024-10-23
Healthy Volunteers
No
Conditions
Interventions
Niraparib 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