drugset / Trial / NCT06539091

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

NCT06539091

Phase 3 Not yet recruiting 51 enrolled Anhui Provincial Hospital
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2024-10-01
Primary completion
2025-10-01
Completion
2026-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluzoparib Small molecule 100 mg Oral
Subject Rivoceranib Small molecule 250 mg Oral