The Efficacy and Safety of The Fuzuloparib Combination With Bevacizumab

Sponsor
Fudan University
Study ID
NCT05819060
Phase
PHASE2
Status
Unknown

Conditions

  • Recurrent Ovarian Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Fuzuloparib Combination with Bevacizumab — DRUG
    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.

Study Details

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.

Key Dates

First listed
Apr 19, 2023
Start date
Apr 30, 2023
Status verified
Apr 2023
Primary completion
Sep 30, 2024
Completion
Mar 30, 2025

Study Design

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

Arms

  • Experimental: Fuzuloparib Combination with Bevacizumab
    Fuzuloparib 150mg/bid ; Bevacizumab 7.5mg/kg，d1，Q3W

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: approximately 1.5 years ]

Central Contacts

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