Clinical trial NCT05819060: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Recurrent Ovarian Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: approximately 1.5 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: Up to approximately 1.5 years
measure: Adverse Events (AEs)
timeFrame: From the first drug administration to within 30 days for the last treatment dose]
Other outcomes:
measure: Exploration of molecular markers
timeFrame: Up to approximately 1.5 years
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Cente
state: Shanghai
Study officials:
affiliation: Department of Gynecologic Oncology, Fudan University Shanghai Cancer
name: Zhong Zheng, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: