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Trial Title:
The Efficacy and Safety of The Fuzuloparib Combination With Bevacizumab
NCT ID:
NCT05819060
Condition:
Recurrent Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Bevacizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Fuzuloparib Combination with Bevacizumab
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.
Arm group label:
Fuzuloparib Combination with Bevacizumab
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Cente
Address:
City:
Shanghai
Zip:
200032
Country:
China
Contact:
Last name:
zheng zhong, MD
Email:
alizheng@126.com
Start date:
April 30, 2023
Completion date:
March 30, 2025
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05819060
