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NOT YET RECRUITING
NCT06539091
PHASE3

Fluzoparib in Combination With Apatinib Mesylate for Maintenance Therapy in Stage III-IV Ovarian Cancer

Sponsor: Anhui Provincial Hospital

View on ClinicalTrials.gov

Summary

This study is a single-arm, open, multicenter, exploratory clinical study to observe and evaluate the efficacy and safety of fluazoparib combined with apatinib mesylate in the treatment of patients with ovarian cancer. Patients with epithelial ovarian, fallopian tube, and primary peritoneal cancers will be selected as the study population with Progression-Free Survival (PFS) as the primary study endpoint, and Overall Survival (OS), Duration Of Response (DOR), Quality of Life Score QoL, Chemotherapy-Free Interval (CFI), Progression-Free Survival 2 (PFS-2), CA125 response criteria by GCGI, to access the safety、Bone Mineral Density (BMD) changes and the tolerability of fluazoparib in combination with apatinib mesylate. The study is planned to enroll 51 subjects, all of whom will receive study treatment after being signed informed and screened.

Official title: A Single-Arm, Open, Multicenter, Exploratory Clinical Study of Fluzoparib in Combination With Apatinib Mesylate for Maintenance Therapy in Stage III-IV Ovarian Cancer (FAT-1)

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

51

Start Date

2024-10-01

Completion Date

2026-10-01

Last Updated

2024-08-06

Healthy Volunteers

No

Interventions

DRUG

Fluzoparib

The study treatment was followed by a 3-week treatment cycle. First day of each dosing cycle, subjects are required to complete various examinations, including vital signs, physical examination, laboratory examination, physical status score, and BMD testing to evaluate the safety and tolerability of continued treatment.

DRUG

Apatinib Mesylate

The study treatment was followed by a 3-week treatment cycle. First day of each dosing cycle, subjects are also required to complete various examinations, including vital signs, physical examination, laboratory examination, physical status score, and BMD testing to evaluate the safety and tolerability of continued treatment.