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

NCT06086665 | Completed DMC FDA Drug

• 1 other identifier: S2022-2461
• Study Type: observational
• Target: 850
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.To evaluate the efficacy and safety of salvage niraparib therapy in Korean women with heavily pretreated epithelial ovarian cancer.

Conditions

Epithelial Ovarian Cancer

Outcome Measures

Primary Outcomes (3)

• Progression-free survival

  Obtain a survival curve using the Kaplan-Meir method in all cohorts, and compare the survival rates between cohort A vs cohort B in total patients, BRCA WT and mutation patients using the log-rank test. Multivariate survival analysis will be performed using Cox's proportional hazard model.

  3 years

• Safety analysis

  The fraction that adverse events occurred, the fraction that dose modification occurred, the fraction that dose delay occurred, and the fraction that treatment discontinuation occurred were calculated, respectively. The comparison of the fractions between groups will be done by the Chi-square test or the Fisher exact test. Comparison of means between groups will be done by Student t test or Mann-Whitney U test.

  3 years

• Overall survival analysis

  Obtain a survival curve using the Kaplan-Meir method in all cohorts, and compare the survival rates between cohort A vs cohort B in total patients, BRCA WT and mutation patients using the log-rank test. Multivariate survival analysis is performed using Cox's proportional hazard model.

  3 years

Study Arms (4)

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

Cohort B

All patients who received or who are receiving niraparib maintenance therapy for primary epithelial ovarian cancer in 1st line setting

Drug: Niraparib

Cohort C

All patients who received or who are receiving niraparib maintenance therapy for recurrent epithelial ovarian cancer in 2nd or 3rd line setting

Drug: Niraparib

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

Drug: Niraparib

Interventions

Niraparib DRUG

Niraparib

Cohort B; Cohort C; Cohort D

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Considering the nature of retrospective study, sample size cannot be calculated based on reference. The investigators have a plan to collect the patient data as much as possible from multi-centers.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead
• Samsung Medical Center: collaborator
• Seoul National University Hospital: collaborator
• Severance Hospital: collaborator
• Gangnam Severance Hospital: collaborator
• Keimyung University Dongsan Medical Center: collaborator
• Kyungpook National University Chilgok Hospital: collaborator
• Seoul St. Mary's Hospital: collaborator
• National Cancer Center, Korea: collaborator
• Pusan National University Yangsan Hospital: collaborator
• Inje University: collaborator
• Pusan National University Hospital: collaborator

Study Sites (1)

Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Interventions

niraparib

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: October 17, 2023
• Study Start: December 1, 2019
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)