Spots Global Cancer Trial Database for A Study of Niraparib in Patients With Ovarian Cancer Who Have Received Three or Four Previous Chemotherapy Regimens
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Trial Identification
Brief Title: A Study of Niraparib in Patients With Ovarian Cancer Who Have Received Three or Four Previous Chemotherapy Regimens
Official Title: A Phase 2, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Niraparib in Patients With Advanced, Relapsed, High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Who Have Received Three or Four Previous Chemotherapy Regimens
Study ID: NCT02354586
Interventions
Study Description
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 three or four 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
GSK Investigational Site, Chandler, Arizona, United States
GSK Investigational Site, Phoenix, Arizona, United States
GSK Investigational Site, Tucson, Arizona, United States
GSK Investigational Site, Burbank, California, United States
GSK Investigational Site, Duarte, California, United States
GSK Investigational Site, Los Angeles, California, United States
GSK Investigational Site, Los Angeles, California, United States
GSK Investigational Site, San Francisco, California, United States
GSK Investigational Site, Santa Barbara, California, United States
GSK Investigational Site, Stanford, California, United States
GSK Investigational Site, New Haven, Connecticut, United States
GSK Investigational Site, Tampa, Florida, United States
GSK Investigational Site, West Palm Beach, Florida, United States
GSK Investigational Site, Atlanta, Georgia, United States
GSK Investigational Site, Chicago, Illinois, United States
GSK Investigational Site, Chicago, Illinois, United States
GSK Investigational Site, Indianapolis, Indiana, United States
GSK Investigational Site, Indianapolis, Indiana, United States
GSK Investigational Site, Covington, Louisiana, United States
GSK Investigational Site, New Orleans, Louisiana, United States
GSK Investigational Site, Baltimore, Maryland, United States
GSK Investigational Site, Boston, Massachusetts, United States
GSK Investigational Site, Boston, Massachusetts, United States
GSK Investigational Site, Burlington, Massachusetts, United States
GSK Investigational Site, Ann Arbor, Michigan, United States
GSK Investigational Site, Minneapolis, Minnesota, United States
GSK Investigational Site, Rochester, Minnesota, United States
GSK Investigational Site, Springfield, Missouri, United States
GSK Investigational Site, Hackensack, New Jersey, United States
GSK Investigational Site, Morristown, New Jersey, United States
GSK Investigational Site, East Setauket, New York, United States
GSK Investigational Site, Jamaica, New York, United States
GSK Investigational Site, Lake Success, New York, United States
GSK Investigational Site, New York, New York, United States
GSK Investigational Site, Durham, North Carolina, United States
GSK Investigational Site, Oklahoma City, Oklahoma, United States
GSK Investigational Site, Medford, Oregon, United States
GSK Investigational Site, Wynnewood, Pennsylvania, United States
GSK Investigational Site, Providence, Rhode Island, United States
GSK Investigational Site, Nashville, Tennessee, United States
GSK Investigational Site, Austin, Texas, United States
GSK Investigational Site, Dallas, Texas, United States
GSK Investigational Site, Fort Worth, Texas, United States
GSK Investigational Site, San Antonio, Texas, United States
GSK Investigational Site, The Woodlands, Texas, United States
GSK Investigational Site, Tyler, Texas, United States
GSK Investigational Site, Spokane, Washington, United States
GSK Investigational Site, Tacoma, Washington, United States
GSK Investigational Site, Calgary, Alberta, Canada
GSK Investigational Site, Toronto, Ontario, Canada
GSK Investigational Site, Montreal, Quebec, Canada
GSK Investigational Site, Montreal, Quebec, Canada
GSK Investigational Site, Montreal, Quebec, Canada
GSK Investigational Site, Montreal, Quebec, Canada
GSK Investigational Site, Sherbrooke, Quebec, Canada
Contact Details
Name: GSK Clinical Trials
Affiliation: GlaxoSmithKline
Role: STUDY_DIRECTOR
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