NCT05819060

The Efficacy and Safety of The Fuzuloparib Combination With Bevacizumab

The Efficacy and Safety of The Fuzuloparib Combination With Bevacizumab in Maintenance Treatment for Platinum-Sensitive Recurrent Ovarian Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study will be a Prospective, Single-arm, Phase Ⅱ Clinical Study. This study intends to explore the efficacy and safety of Fuzuloparib combined with bevacizumab in the maintenance treatment of patients with platinum-sensitive ovarian cancer. The progression-free survival, OS, and safety were evaluated based on RECIST V1.1.

Detailed description

Due to the lack of effective predictive molecular markers in the maintenance treatment phase, it is difficult to assess the effectiveness of maintenance treatment. This project plans to collect blood and urine from subjects before maintenance treatment, during relapse, and for follow-up molecular marker exploration research.

Conditions

• Recurrent Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Fuzuloparib Combination with Bevacizumab	For the first 6 patients, if DLT≤33.3%, Fuzuloparib 150mg/bid will be used for follow-up research; if DLT\>33.3%, Fuzuloparib will be used for follow-up research at 100mg/bid; Bevacizumab 7.5mg/kg, d1, Q3W.

Timeline

• Start date: 2023-04-30
• Primary completion: 2024-09-30
• Completion: 2025-03-30
• First posted: 2023-04-19
• Last updated: 2023-04-19

Locations

1 site across 1 country: China