NCT06086665

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 850 (actual)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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 heavily pretreated epithelial ovarian cancer patients were confirmed in the -QUADRA trial. However, safety and efficacy data in Korean women are still scanty. The purpose of this study was to evaluate the safety and efficacy of niraparib in Korean women with primary and recurrent epithelial ovarian cancer.

Conditions

• Epithelial Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Niraparib	Niraparib

Timeline

• Start date: 2019-12-01
• Primary completion: 2022-10-31
• Completion: 2022-10-31
• First posted: 2023-10-17
• Last updated: 2026-02-04

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated drug study