NCT05187208

PARP Inhibitor Oral Maintenance in Low-Risk Ovarian Cancer

A Phase IV Open-label, Multicenter Study of Niraparib as Maintenance Therapy in BRCA Wild-type, Newly Diagnosed Advanced Ovarian Cancer Patients in Korea

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This study is a 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. The study will assess the effectiveness of progression-free survival (12 months PFS rate) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The subject will be treated up to three years or until disease progression as below: 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.

Conditions

• Epithelial Ovarian Cancer
• Ovarian Cancer
• Ovarian Cancer Stage III
• Ovarian Cancer Stage IV

Interventions

Type	Name	Description
DRUG	Niraparib	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.

Timeline

• Start date: 2022-01-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2022-01-11
• Last updated: 2022-01-26