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Clinical Trial Details

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Brief Title A Study of Niraparib in Patients With Ovarian Cancer Who Have Received at Least Three Previous Chemotherapy Regimens
Official Title A Phase 2, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Niraparib in Women With Advanced, Relapsed, High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Who Have Received at Least Three Previous Chemotherapy Regimens
Principal Investigator Fleming, Gini
Brief 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 at least three 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.
Gender Female
Ages 18 Years
Enrollment 225
Accepts Healthy Volunteers No
Lead Sponsor Tesaro, Inc.Industry
Collaborator Facing Our Risk of Cancer EmpoweredOther
Study Design Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Phase Phase 2
Study Type Interventional
Contact Name
Contact Phone 1-855-702-8222 (adult trials) or 1-773-702-6808 (pediatric trials)
Condition Ovarian Cancer
Detail for Health Professional (on clinicaltrials.gov)
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