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

Completed

• Conditions: Epithelial Ovarian Cancer
• Interventions: Drug: Niraparib

• Registration Number: NCT06086665
• Lead Sponsor: Asan Medical Center

Brief Summary

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.

Detailed Description

It has been three years since niraparib was introduced into Korea, and about 600 Korean patients with epithelial ovarian cancer have been treated with this drug. The efficacy and safety of niraparib in primary and recurrent epithelial ovarian cancer were well demonstrated in the NOVA trial and the PRIMA trial, and the efficacy and safety of niraparib in heav...

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2019-12-01
• Primary Completion: 2022-10-31
• Study Completion: 2022-10-31
• Status Verified: 2023-10
• Study First Submitted: 2023-10-11
• Study First Submitted QC: 2023-10-11
• Last Update Submitted: 2023-10-11
• Study First Posted: 2023-10-17
• Last Update Posted: 2023-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 850

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort C	Niraparib	All patients who received or who are receiving niraparib maintenance therapy for recurrent epithelial ovarian cancer in 2nd or 3rd line setting
Cohort D	Niraparib	All patients who received or who are receiving salvage niraparib therapy for recurrent epithelial ovarian cancer in 4th line or more line setting
Cohort B	Niraparib	All patients who received or who are receiving niraparib maintenance therapy for primary epithelial ovarian cancer in 1st line setting

Primary Outcome Measures

Name	Time	Method
Progression-free survival	3 years	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.
Safety analysis	3 years	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 ...
Overall survival analysis	3 years	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.

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of