A Phase 2, 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 Following Front-Line Platinum-Based Chemotherapy with Bevacizumab
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.
View more details from ClinicalTrials.gov.
For more information about a clinical trial, clinical trial eligibility, or informed consent, contact our research nurses by phone or email:
Please Note: Any eligibility criteria noted are subject to change. Our research nurses can provide you with the most current eligibility and exclusion criteria. Any study involvement to be undertaken must ultimately be determined on an individual basis.