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

Contact Investigators or Research Sites near you

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Beth Zaharoff

Alaska Women's Care
Anchorage, AK United States

Beth Zaharoff

Mercy Medical Center
Baltimore, MD United States

Beth Zaharoff

North Shore Hematology and Oncology
East Setauket, NY United States

Beth Zaharoff

The Center for Cancer and Blood Disorders
Fort Worth, TX United States

Beth Zaharoff

University of Alabama
Mobile, AL United States

Beth Zaharoff

Providence Saint Joseph Medical Center
Burbank, CA United States

Beth Zaharoff

FCS South
Fort Myers, FL United States

Beth Zaharoff

Florida Cancer Specialists North
Saint Petersburg, FL United States

Beth Zaharoff

Karmanos Cancer Institute
Detroit, MI United States

Beth Zaharoff

St. Dominic-Gynecologic Oncology
Jackson, MS United States

Beth Zaharoff

University of Missouri/ Ellis Fischel Cancer Center
Columbia, MO United States

Beth Zaharoff

HCA Midwest Health
Kansas City, MO United States

Beth Zaharoff

Nebraska Methodist Hospital
Omaha, NE United States

Beth Zaharoff

Dartmouth Hitchcock Medical Center
Lebanon, NH United States

Beth Zaharoff

Englewood Hospital
Englewood, NJ United States

Beth Zaharoff

San Juan Oncology Associates
Farmington, NM United States

Beth Zaharoff

Queens Hospital Center - Queens Cancer Center
Jamaica, NY United States

Beth Zaharoff

Hope Women's Cancer Center
Asheville, NC United States

Beth Zaharoff

Chattanooga's Program in Women's Oncology
Chattanooga, TN United States

Beth Zaharoff

Wellmont Women's Cancer Services
Kingsport, TN United States

Beth Zaharoff

Tennessee Oncology
Nashville, TN United States

Beth Zaharoff

Oncology Consultants, P.A.
Houston, TX United States

Beth Zaharoff

Providence Regional Cancer System
Lacey, WA United States

Beth Zaharoff

Seattle Cancer Care Alliance
Seattle, WA United States

Beth Zaharoff

Valley View Hospital
Glenwood Springs, CO United States

Beth Zaharoff

Kansas University Medical Center
Westwood, KS United States

Beth Zaharoff

Henry Ford Hospital
Detroit, MI United States

Beth Zaharoff

Morristown Medical Center
Morristown, NJ United States

Beth Zaharoff

Women and Infants Hospital
Providence, RI United States

Beth Zaharoff

University of Texas Health Science Center of San Antonio
San Antonio, TX United States

Recruitment Status: Closed


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