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

RecruitingOBSERVATIONAL
Enrollment

300

Participants

Timeline

Start Date

September 2, 2024

Primary Completion Date

December 30, 2025

Study Completion Date

January 7, 2026

Conditions
Ovarian Cancer
Interventions
DRUG

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"

Trial Locations (12)

Unknown

RECRUITING

Oddział Onkologii Ginekologicznej Białostockiego Centrum Onkologii, Bialystok

NOT_YET_RECRUITING

Klinika Położnictwa i Ginekologii, Ginekologii Onkologicznej Uniwersyteckie Centrum Kliniczne, Gdansk

NOT_YET_RECRUITING

III Klinika Radioterapii i Chemioterapii Narodowego Instytutu Onkologicznego w Gliwicach, Gliwice

NOT_YET_RECRUITING

Świętokrzyskie Centrum Onkologii, Kielce

NOT_YET_RECRUITING

Klinika Ginekologii Onkologicznej Narodowego Instytutu Onkologicznego w Krakowie, Krakow

NOT_YET_RECRUITING

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

NOT_YET_RECRUITING

Opolskie Centrum Onkologii, Opole

NOT_YET_RECRUITING

Oddział Onkologii Klinicznej i Radioterapii, Siedleckie Centrum Onkologii, Siedlce

NOT_YET_RECRUITING

Klinika Ginekologii Operacyjnej i Onkologii Ginekologicznej Dorosłych i Dziewcząt PUM, Szczecin

NOT_YET_RECRUITING

Klinika Ginekologii Operacyjnej i Onkologii Ginekologicznej Dorosłych i Dziewcząt PUM, Szczecin

NOT_YET_RECRUITING

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

NOT_YET_RECRUITING

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

All Listed Sponsors
lead

Pomeranian Medical University Szczecin

OTHER