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The Efficacy and Safety of The Fuzuloparib Combination With Bevacizumab

Primary Purpose

Recurrent Ovarian Cancer

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Fuzuloparib Combination with Bevacizumab
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Ovarian Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Patients with platinum-sensitive recurrent ovarian cancer confirmed by pathology or histology; Patients who have previously received platinum-based chemotherapy and had a recurrence interval of > 6 months before the last platinum-based chemotherapy; Patients who have previously received bevacizumab and did not experience progression within 3 months during the use of bevacizumab; Patients who have previously received PARP inhibitors and did not experience progression within 12 months during the use of PARP inhibitors; The patient achieved a complete or partial response after the last platinum-based chemotherapy; Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; The patient has a life expectancy of at least 3 months and sufficient organ function; 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; The patient voluntarily agrees to participate in this study and signs an informed consent form. Exclusion Criteria: Patients who are known to be allergic or intolerant to chemotherapy drugs or their excipients and cannot swallow medication; Patients who have undergone major surgery within 28 days prior to enrollment; Patients with central nervous system metastases or a history of seizures within the past 12 months; Uncontrolled hypertension: systolic blood pressure ≥180mmHg, diastolic blood pressure ≥90mmHg; NYHA functional class ≥ III; Patients with severe, uncontrolled systemic diseases; 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; Pregnant or lactating patients, or patients who cannot guarantee effective contraception during the study treatment period; Patients with poorly controlled neurological or psychiatric disorders or mental illness, poor compliance, and inability to cooperate or describe treatment response; Patients judged by the investigator to be unsuitable for participation in this study.

Sites / Locations

  • Fudan University Shanghai Cancer Cente

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fuzuloparib Combination with Bevacizumab

Arm Description

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

Outcomes

Primary Outcome Measures

Progression-free survival (PFS)
according to RECIST v1.1

Secondary Outcome Measures

Overall survival (OS)
according to RECIST v1.1
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.

Full Information

First Posted
March 19, 2023
Last Updated
April 14, 2023
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT05819060
Brief Title
The Efficacy and Safety of The Fuzuloparib Combination With Bevacizumab
Official Title
The Efficacy and Safety of The Fuzuloparib Combination With Bevacizumab in Maintenance Treatment for Platinum-Sensitive Recurrent Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 30, 2023 (Anticipated)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
March 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Ovarian Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fuzuloparib Combination with Bevacizumab
Arm Type
Experimental
Arm Description
Fuzuloparib 150mg/bid ; Bevacizumab 7.5mg/kg,d1,Q3W
Intervention Type
Drug
Intervention Name(s)
Fuzuloparib Combination with Bevacizumab
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
according to RECIST v1.1
Time Frame
approximately 1.5 years
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
according to RECIST v1.1
Time Frame
Up to approximately 1.5 years
Title
Adverse Events (AEs)
Description
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.
Time Frame
From the first drug administration to within 30 days for the last treatment dose]
Other Pre-specified Outcome Measures:
Title
Exploration of molecular markers
Description
Through the analysis of serum and urine proteomics and metabolomics, predictive PFS markers were screened,for example,CA 125, ctDNA
Time Frame
Up to approximately 1.5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with platinum-sensitive recurrent ovarian cancer confirmed by pathology or histology; Patients who have previously received platinum-based chemotherapy and had a recurrence interval of > 6 months before the last platinum-based chemotherapy; Patients who have previously received bevacizumab and did not experience progression within 3 months during the use of bevacizumab; Patients who have previously received PARP inhibitors and did not experience progression within 12 months during the use of PARP inhibitors; The patient achieved a complete or partial response after the last platinum-based chemotherapy; Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; The patient has a life expectancy of at least 3 months and sufficient organ function; 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; The patient voluntarily agrees to participate in this study and signs an informed consent form. Exclusion Criteria: Patients who are known to be allergic or intolerant to chemotherapy drugs or their excipients and cannot swallow medication; Patients who have undergone major surgery within 28 days prior to enrollment; Patients with central nervous system metastases or a history of seizures within the past 12 months; Uncontrolled hypertension: systolic blood pressure ≥180mmHg, diastolic blood pressure ≥90mmHg; NYHA functional class ≥ III; Patients with severe, uncontrolled systemic diseases; 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; Pregnant or lactating patients, or patients who cannot guarantee effective contraception during the study treatment period; Patients with poorly controlled neurological or psychiatric disorders or mental illness, poor compliance, and inability to cooperate or describe treatment response; Patients judged by the investigator to be unsuitable for participation in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhong Zheng, Ph.D
Phone
02164175590
Ext
82900
Email
alizheng@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhong Zheng, Ph.D
Organizational Affiliation
Department of Gynecologic Oncology, Fudan University Shanghai Cancer
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Shanghai Cancer Cente
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zheng zhong, MD
Email
alizheng@126.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data is available per require after approved by ethics broad

Learn more about this trial

The Efficacy and Safety of The Fuzuloparib Combination With Bevacizumab

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