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The Efficacy and Safety of The Fuzuloparib Combination With Bevacizumab | Clinical Trials | Clareo Health

UNKNOWNPHASE2

The Efficacy and Safety of The Fuzuloparib Combination With Bevacizumab

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

NCT05819060•Fudan University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

FEMALE

Healthy Volunteers

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.

Locations (1)

Fudan University Shanghai Cancer Cente

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

April 30, 2023

Primary Completion Date

September 30, 2024

Completion Date

March 30, 2025

Last Updated

April 19, 2023

Enrollment

ESTIMATED participants

Conditions

Recurrent Ovarian Cancer

Interventions

Fuzuloparib Combination with Bevacizumab

DRUG

Contacts

Zhong Zheng, Ph.D

CONTACT

02164175590 alizheng@126.com

CPI-0209 Plus Carboplatin in Patients With Platinum Sensitive Recurrent Ovarian Cancer

NCT05942300

Recurrent Ovarian Cancer

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ACTIVE_NOT_RECRUITINGPHASE2

A Clinical Study Evaluating a Combination of Oregovomab and Niraparib in Adult Women With Platinum Sensitive Recurrent Ovarian Cancer.

NCT05335993

Recurrent Ovarian CancerRecurrent Epithelial Cancer of Ovary+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 19, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The Efficacy and Safety of The Fuzuloparib Combination With Bevacizumab

Inclusion Criteria

Exclusion Criteria

CPI-0209 Plus Carboplatin in Patients With Platinum Sensitive Recurrent Ovarian Cancer

A Clinical Study Evaluating a Combination of Oregovomab and Niraparib in Adult Women With Platinum Sensitive Recurrent Ovarian Cancer.

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