NCT06539091

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

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)

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 51 (estimated)
• Sponsor: Anhui Provincial Hospital · Other Government
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

During the treatment period, subjects were given fluazoparib capsules orally, two capsules/dose (50mg/capsule) twice daily, taken orally in the morning and in the evening, as a continuous dosage. Subjects will also receive oral apatinib mesylate tablets, one tablet/dose (250 mg/tablet), once daily, continuously. Treatment will continue until an event occurs that meets the criteria for discontinuation of treatment. Safety evaluations will be performed on Day 1 of each 3-week treatment cycle (vital signs, physical examination, laboratory examination, physical status score and BMD testing); imaging evaluations and once CA125 test will be performed every 6 weeks for the first 24 weeks of dosing, and every 9 weeks thereafter to assess efficacy, and for 12 months or until an event occurs that meets the criteria for treatment discontinuation. Dose suspension or downward adjustment may be made during the study period based on the occurrence of adverse events in subjects.

Conditions

• Epithelial Ovarian Cancer
• Efficacy
• Safety
• Bone Mineral Density
• Tolerability

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-10-01
• Completion: 2026-10-01
• First posted: 2024-08-06
• Last updated: 2024-08-06