PARP Inhibitor Oral Maintenance in Low-Risk Ovarian Cancer

Sponsor
Seoul National University Hospital
Study ID
NCT05187208
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Niraparib — DRUG
    Niraparib 200mg or 300mg (once daily \[QD\])\* \*The recommended starting dosage of niraparib is 200mg QD. For patients who weigh ≥77 kg and have baseline platelet count ≥150,000/μL, the recommended starting dosage is 300 mg QD.

Study Details

This study is the phase IV, open-label, clinical trial to determine the efficacy of niraparib maintenance therapy in BRCA1/2 wild-type, advanced-stage, low-risk, primary ovarian cancer patients.

Key Dates

Start date
Jan 31, 2022
Status verified
Jan 2022
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
102 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental
    BRCA1/2 wild-type, advanced-stage, low-risk, primary ovarian cancer patients (high-grade serous or high-grade endoemtrioid)

Primary Outcome Measure

Progression-free survival (12 month PFS rate) [ Time Frame: 12 months ]

Central Contacts

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