The Efficacy and Safety of The Fuzuloparib Combination With Bevacizumab

April 14, 2023 updated by: Zhong Zheng MD, Fudan University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

44

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Zhong Zheng, Ph.D
  • Phone Number: 82900 02164175590
  • Email: alizheng@126.com

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Fudan University Shanghai Cancer Cente
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fuzuloparib Combination with Bevacizumab
Fuzuloparib 150mg/bid ; Bevacizumab 7.5mg/kg，d1，Q3W
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: approximately 1.5 years
according to RECIST v1.1
approximately 1.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Up to approximately 1.5 years
according to RECIST v1.1
Up to approximately 1.5 years
Adverse Events (AEs)
Time Frame: 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.
From the first drug administration to within 30 days for the last treatment dose]

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploration of molecular markers
Time Frame: Up to approximately 1.5 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Zhong Zheng, Ph.D, Department of Gynecologic Oncology, Fudan University Shanghai Cancer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 30, 2023

Primary Completion (Anticipated)

September 30, 2024

Study Completion (Anticipated)

March 30, 2025

Study Registration Dates

First Submitted

March 19, 2023

First Submitted That Met QC Criteria

April 14, 2023

First Posted (Actual)

April 19, 2023

Study Record Updates

Last Update Posted (Actual)

April 19, 2023

Last Update Submitted That Met QC Criteria

April 14, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-02-3121

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data is available per require after approved by ethics broad

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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