NCT04229615

A Study of Fluzoparib±Apatinib Versus Placebo Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on First-Line Platinum-Based Chemotherapy

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase III Clinical Trial Evaluating the Efficacy and Safety of Fluzoparib±Apatinib for Maintenance Treatment in Patients With Advanced Ovarian Cancer Who Have Achieved Effective Response After First-line Platinum-containing Chemotherapy

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 690 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, blinded, 3-arm Phase 3 study to evaluate the efficacy and safety of Fluzoparib alone or with Apatinib versus Placebo, as maintenance treatment, in patients with Stage III or IV ovarian cancer. Patients must have completed first-line platinum based regimen with Complete Response (CR) or Partial Response (PR). The study contains a Safety Lead-in Phase in which the safety and tolerability of Fluzoparib+Apatinib will be assessed prior to the Phase 3 portion of the study.

Conditions

• Ovarian Cancer
• Fallopian Tube Cancer
• Primary Peritoneal Carcinoma

Interventions

Type	Name	Description
DRUG	Fluzoparib; Apatinib	Drug: Fluzoparib Orally twice daily; Apatinib Orally once daily
DRUG	Fluzoparib	Fluzoparib Orally twice daily
DRUG	Placebo	Placebo

Timeline

• Start date: 2020-06-02
• Primary completion: 2023-06-30
• Completion: 2024-04-01
• First posted: 2020-01-18
• Last updated: 2022-04-25

Locations

1 site across 1 country: China