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

Sponsor
Asan Medical Center
Study ID
NCT06086665
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Dec 1, 2019
Status verified
Feb 2026
Primary completion
Oct 31, 2022
Completion
Oct 31, 2022

Study Design

Enrollment
850 participants (actual)

Arms

  • Arm: 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
  • Arm: Cohort B
    All patients who received or who are receiving niraparib maintenance therapy for primary epithelial ovarian cancer in 1st line setting
  • Arm: Cohort C
    All patients who received or who are receiving niraparib maintenance therapy for recurrent epithelial ovarian cancer in 2nd or 3rd line setting
  • Arm: 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

Primary Outcome Measure

Progression-free survival [ Time Frame: 3 years ]

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