NCT04986371

Real-world Study of Niraparib Maintenance Treatment in Patients With Newly Diagnosed Ovarian Cancer

An Observational, Non-interventional Study of Niraparib Maintenance Treatment in Patients With Ovarian Cancer After Frontline Platinum-based Chemotherapy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Ling-Ying Wu · Unknown
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single-arm, multi-center、non-interventional real-world study, which evaluate treatment pattern, safety and efficacy of Niraparib as first-line maintenance treatment for Chinese patient with newly diagnosed ovarian cancer , fallopian tube cancer, and primary peritoneal cancer in real world clinical practice.

Detailed description

In this study, 300 patients will be enrolled. Eligible patients will be those with histologically confirmed epithelial ovarian cancer, carcinoma of fallopian tube or primary peritoneal carcinoma. Patients must have received one line of platinum-based chemotherapy, and be in clinically complete or partial response following the platinum-based chemotherapy prior to enrollment in the study. Patients will be treated with Niraparib according to the physician's judgement till disease progression, discontinuation for other reasons or death. The primary endpoint is treatment pattern of Niraparib as first-line maintenance treatment for ovarian cancer patients. The second endpoints include AE, PFS and quality of life.

Conditions

• Epithelial Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Niraparib	Usage following drug insert is recommended

Timeline

• Start date: 2021-08-10
• Primary completion: 2022-08-31
• Completion: 2025-02-28
• First posted: 2021-08-02
• Last updated: 2021-08-02