The Efficacy and Safety of The Fuzuloparib Combination With Bevacizumab

Phase 2

Not yet recruiting

• Conditions: Recurrent Ovarian Cancer
• Interventions: Drug: Fuzuloparib Combination with Bevacizumab

• Registration Number: NCT05819060
• Lead Sponsor: Fudan University

Brief 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.

Study Timeline

• Study First Submitted: 2023-03-19
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-14
• Last Update Submitted: 2023-04-14
• Study First Posted: 2023-04-19
• Last Update Posted: 2023-04-19
• Study Start: 2023-04-30
• Primary Completion: 2024-09-30
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 44

Inclusion Criteria

1. Patients with platinum-sensitive recurrent ovarian cancer confirmed by pathology or histology;
2. Patients who have previously received platinum-based chemotherapy and had a recurrence interval of > 6 months before the last platinum-based chemotherapy;
3. Patients who have previously received bevacizumab and did not experience progression within 3 months during the use of bevacizumab;
4. Patients who have previously received PARP inhibitors and did not experience progression within 12 months during the use of PARP inhibitors;
5. The patient achieved a complete or partial response after the last platinum-based chemotherapy;
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
7. The patient has a life expectancy of at least 3 months and sufficient organ function;
8. The patient has sufficient bone marrow reserves and organ function, including a creatinine clearance rate of 45 mL/min calculated using the standard Cockcroft and Gault formula;
9. The patient voluntarily agrees to participate in this study and signs an informed consent form.

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Exclusion Criteria

1. Patients who are known to be allergic or intolerant to chemotherapy drugs or their excipients and cannot swallow medication;
2. Patients who have undergone major surgery within 28 days prior to enrollment;
3. Patients with central nervous system metastases or a history of seizures within the past 12 months;
4. Uncontrolled hypertension: systolic blood pressure ≥180mmHg, diastolic blood pressure ≥90mmHg;
5. NYHA functional class ≥ III;
6. Patients with severe, uncontrolled systemic diseases;
7. Patients who have received any other investigational drug treatment or participated in any other clinical trials within 30 days prior to enrollment in this study;
8. Pregnant or lactating patients, or patients who cannot guarantee effective contraception during the study treatment period;
9. Patients with poorly controlled neurological or psychiatric disorders or mental illness, poor compliance, and inability to cooperate or describe treatment response;
10. Patients judged by the investigator to be unsuitable for participation in this study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fuzuloparib Combination with Bevacizumab	Fuzuloparib Combination with Bevacizumab	Fuzuloparib 150mg/bid ; Bevacizumab 7.5mg/kg，d1，Q3W

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	approximately 1.5 years	according to RECIST v1.1

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	Up to approximately 1.5 years	according to RECIST v1.1
Adverse Events (AEs)	From the first drug administration to within 30 days for the last treatment dose]	According to CTCAE V5.0 criteria, During the trial, the adverse event record form should be truthfully filled in, including the occurrence time, severity, correlation with study treatment, duration, measures taken and outcome of the adverse event.

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Cente; 🇨🇳 Shanghai, Shanghai, China