Clinical trial

The Real World Efficacy and Safety of Niraparib in Korean Women With Primary and Recurrent Epithelial Ovarian Cancer

Name
S2022-2461
Description
1. To evaluate the efficacy and safety of niraparib in Korean women with primary and recurrent epithelial ovarian cancer who underwent niraparib maintenance therapy 2. To evaluate the efficacy and safety of salvage niraparib therapy in Korean women with heavily pretreated epithelial ovarian cancer.
Trial arms
Trial start
2019-12-01
Estimated PCD
2022-10-31
Trial end
2022-10-31
Status
Completed
Treatment
Niraparib
Niraparib
Arms:
Cohort B, Cohort C, Cohort D
Size
850
Primary endpoint
Progression-free survival
3 years
Safety analysis
3 years
Overall survival analysis
3 years
Eligibility criteria
Inclusion Criteria: * Patients were diagnosed with all histologic type of epithelial ovarian cancer * Observation cohort (Cohort A): All patients who did not receive any kind of maintenance therapy for primary epithelial ovarian cancer from Dec 2019 to Dec 2022 * Treatment cohort: Epithelial ovarian cancer patients who treated with niraparib as maintenance treatment in any line from Dec 2019 to Dec 2022 * Cohort B: All patients who received or who are receiving niraparib maintenance therapy for primary epithelial ovarian cancer in 1st line setting * Cohort C: All patients who received or who are receiving niraparib maintenance therapy for recurrent epithelial ovarian cancer in 2nd or 3rd line setting * Cohort D: All patients who received or who are receiving salvage niraparib therapy for recurrent epithelial ovarian cancer in 4th line or more line setting Exclusion Criteria: * Borderline ovarian tumor * Malignant ovarian germ cell tumor * Malignant sex-cord stroma tumor * Other malignancy within 5 years of diagnosis of epithelial ovarian cancer excluding carcinoma in situ of uterine cervix, endometrium, bladder, stomach, papillary thyroid cancer, and non-melanoma skin cancer
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 850, 'type': 'ACTUAL'}}
Updated at
2023-10-17

1 organization

1 drug

1 indication

Indication
Ovarian Cancer