The Efficacy and Safety of The Fuzuloparib Combination With Bevacizumab

NCT ID: NCT05819060

Last Updated: 2023-04-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-30
• Study Completion Date: 2025-03-30

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.

Conditions

Recurrent Ovarian Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fuzuloparib Combination with Bevacizumab

Fuzuloparib 150mg/bid ; Bevacizumab 7.5mg/kg，d1，Q3W

Group Type: EXPERIMENTAL

Fuzuloparib Combination with Bevacizumab

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Zhong Zheng MD

Professor, Director of Gynecologic Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhong Zheng, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Department of Gynecologic Oncology, Fudan University Shanghai Cancer

Locations

Fudan University Shanghai Cancer Cente

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Zhong Zheng, Ph.D

Role: CONTACT

alizheng@126.com

02164175590 ext. 82900

Facility Contacts

zheng zhong, MD

Role: primary

alizheng@126.com

Other Identifiers

2023-02-3121

Identifier Type: -

Identifier Source: org_study_id