NCT06141265

Niraparib Maintenance in HRD-Positive Advanced Ovarian Cancer Following Front-Line Chemotherapy + Bevacizumab

Chemotherapy Combined With Bevacizumab Followed by Niraparib Monotherapy in Newly Diagnostic Advanced Ovarian Cancer With HRD Positive : A Perspective, Multicenter, Single-arm Phase II Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, open-label, single-arm phase II clinical trial investigating the efficacy and safety of niraparib monotherapy maintenance in HRD-positive newly diagnosed advanced epithelial ovarian cancer (EOC), including primary peritoneal and/or fallopian tube tumors, following response to front-line chemotherapy in combination with bevacizumab. A total of 116 patients will be enrolled.

Conditions

• Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma

Interventions

Type	Name	Description
DRUG	Niraparib	The starting dose is 300mg or 200mg QD based on the subject's baseline body weight or baseline platelet count

Timeline

• Start date: 2023-11-01
• Primary completion: 2026-09-01
• Completion: 2027-09-01
• First posted: 2023-11-21
• Last updated: 2023-11-21

Locations

1 site across 1 country: China