NCT04392102

A Study of Niraparib in Patients With Relapsed Ovarian Cancer

A Phase 2, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Niraparib in Patients With Advanced and Relapsed Ovarian Cancer After 3 or 4 Previous Chemotherapies

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Zai Lab (Shanghai) Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, open-label, single arm study to evaluate the safety and efficacy of niraparib in ovarian cancer patients who have received three or four previous chemotherapy regimens. Niraparib is an orally active PARP inhibitor. Niraparib will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by Eastern Cooperative Oncology Group performance status (ECOG). Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), RECIST tumor assessments and safety laboratory values.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	ZL-2306(Niraparib）	The starting dose is 300mg or 200mg QD based on the subject's baseline body weight or baseline platelet count

Timeline

• Start date: 2020-08-04
• Primary completion: 2021-04-08
• Completion: 2022-08-11
• First posted: 2020-05-18
• Last updated: 2022-08-29

Locations

7 sites across 1 country: China