The Efficacy and Safety of The Fuzuloparib Combination With Bevacizumab

NCT05819060 | Unknown Phase 2

• 1 other identifier: 2023-02-3121
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  according to RECIST v1.1

  approximately 1.5 years

Secondary Outcomes (2)

• Overall survival (OS)

  Up to approximately 1.5 years

• Adverse Events (AEs)

  From the first drug administration to within 30 days for the last treatment dose]

Other Outcomes (1)

• Exploration of molecular markers

  Up to approximately 1.5 years

Study Arms (1)

Fuzuloparib Combination with Bevacizumab

EXPERIMENTAL

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

Drug: Fuzuloparib Combination with Bevacizumab

Interventions

Fuzuloparib Combination with Bevacizumab DRUG

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.

Fuzuloparib Combination with Bevacizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Cente

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Zhong Zheng, Ph.D

  Department of Gynecologic Oncology, Fudan University Shanghai Cancer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhong Zheng, Ph.D

CONTACT

02164175590; alizheng@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director of Gynecologic Oncology

Study Record Dates

• First Submitted: March 19, 2023
• First Posted: April 19, 2023
• Study Start: April 30, 2023
• Primary Completion: September 30, 2024
• Study Completion: March 30, 2025
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)