Last updated on March 2019

Phase 2 A Study of Niraparib Combined With Bevacizumab Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

Brief description of study

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.

Clinical Study Identifier: NCT03326193

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Alaska Women's Care

Anchorage, AK United States

Mercy Medical Center

Baltimore, MD United States

North Shore Hematology and Oncology

East Setauket, NY United States

The Center for Cancer and Blood Disorders

Fort Worth, TX United States

University of Alabama

Mobile, AL United States

Providence Saint Joseph Medical Center

Burbank, CA United States

FCS South

Fort Myers, FL United States

Florida Cancer Specialists North

Saint Petersburg, FL United States

Karmanos Cancer Institute

Detroit, MI United States

St. Dominic-Gynecologic Oncology

Jackson, MS United States

HCA Midwest Health

Kansas City, MO United States

Nebraska Methodist Hospital

Omaha, NE United States

Dartmouth Hitchcock Medical Center

Lebanon, NH United States

Englewood Hospital

Englewood, NJ United States

San Juan Oncology Associates

Farmington, NM United States

Hope Women's Cancer Center

Asheville, NC United States

Chattanooga's Program in Women's Oncology

Chattanooga, TN United States

Wellmont Women's Cancer Services

Kingsport, TN United States

Tennessee Oncology

Nashville, TN United States

Oncology Consultants, P.A.

Houston, TX United States

Providence Regional Cancer System

Lacey, WA United States

Seattle Cancer Care Alliance

Seattle, WA United States

Valley View Hospital

Glenwood Springs, CO United States

Kansas University Medical Center

Westwood, KS United States

Henry Ford Hospital

Detroit, MI United States

Morristown Medical Center

Morristown, NJ United States

Women and Infants Hospital

Providence, RI United States

Recruitment Status: Closed

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