NCT02354586

A Study of Niraparib in Patients With Ovarian Cancer Who Have Received Three or Four Previous Chemotherapy Regimens

A Phase 2, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Niraparib in Patients With Advanced, Relapsed, High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Who Have Received Three or Four Previous Chemotherapy Regimens

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 463 (actual)
• Sponsor: Tesaro, Inc. · 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 Neoplasms
• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Niraparib

Timeline

• Start date: 2015-03-23
• Primary completion: 2018-02-28
• Completion: 2021-08-23
• First posted: 2015-02-03
• Last updated: 2022-09-15
• Results posted: 2020-04-09

Locations

55 sites across 2 countries: United States, Canada