Maintenance Treatment in Patients with Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal CancerStatus: open
17-420 - A Phase 1, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of Niraparib Combined with Bevacizumab as Maintenance Treatment in Patients with Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Treatment for Ovarian Cancer
This is a Phase 2, open-label, single arm study to evaluate progression free survival rate at 18 months as well as evaluating the safety and efficacy of niraparib in combination with bevacizumab as maintenance therapy in patients with advanced ovarian cancer patients who have received prior front-line therapy with platinum-based chemotherapy in combination with bevacizumab and who have had at least one prior attempt at debulking surgery. Niraparib is an orally active poly adenosine diphosphate-ribose (PARP) inhibitor. Niraparib will be administered by mouth once daily continuously during a 21-day cycle. Bevacizumab will be administered intravenously D1 of each 21-day cycle for up to 15 mos, including the duration of the front-line therapy. 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. IRB Number 17-420
SponsorsThis trial is sponsored by Tesaro, Inc..
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Providers Associated With This Trial
- Rodney P. Rocconi, M.D., F.A.C.O.G.Gynecologic OncologistInterim Director of Mitchell Cancer Institute; Chief of Gynecologic Oncology Service; Associate Director for Clinical Research, Abraham A. Mitchell Clinical Cancer Research Scholar; Professor of Interdisciplinary Clinical Oncology