A Study of Niraparib in Patients With Relapsed Ovarian Cancer
Status:
Active, not recruiting
Trial end date:
2023-07-31
Target enrollment:
Participant gender:
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.