The Efficacy and Safety of The Fuzuloparib Combination With Bevacizumab

Recurrent Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05819060
• Other study ID #: 2023-02-3121
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 30, 2023
• Est. completion date: March 30, 2025

Study information

• Verified date: April 2023
• Source: Fudan University
• Contact: Zhong Zheng, Ph.D
• Phone: 02164175590
• Email: alizheng[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: March 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Neoplasms
• Recurrent Ovarian Cancer

Intervention

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.

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Cente	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploration of molecular markers	Through the analysis of serum and urine proteomics and metabolomics, predictive PFS markers were screened,for example,CA 125, ctDNA	Up to approximately 1.5 years
Primary	Progression-free survival (PFS)	according to RECIST v1.1	approximately 1.5 years
Secondary	Overall survival (OS)	according to RECIST v1.1	Up to approximately 1.5 years
Secondary	Adverse Events (AEs)	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.	From the first drug administration to within 30 days for the last treatment dose]