Spots Global Cancer Trial Database for A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer
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Trial Identification
Brief Title: A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer
Official Title: A Phase 3 Randomized Double-blind Trial of Maintenance With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer.
Study ID: NCT01847274
Study Description
Brief Summary: This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of niraparib as maintenance in platinum sensitive ovarian cancer patients who have either gBRCAmut or a tumor with high-grade serous histology and who have responded to their most recent chemotherapy containing a platinum agent. Niraparib is an orally active PARP inhibitor. Niraparib or placebo (in a 2:1 ratio) will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by the Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI), European Quality of Life scale, 5-Dimensions (EQ-5D), and a neuropathy questionnaire. Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values. The primary objective of this study is to evaluate efficacy of niraparib as maintenance therapy in patients who have platinum sensitive ovarian cancer as assessed by the prolongation of progression free survival (PFS).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
GSK Investigational Site, Phoenix, Arizona, United States
GSK Investigational Site, Tucson, Arizona, United States
GSK Investigational Site, Los Angeles, California, United States
GSK Investigational Site, Los Angeles, California, United States
GSK Investigational Site, Palo Alto, California, United States
GSK Investigational Site, San Francisco, California, United States
GSK Investigational Site, New Haven, Connecticut, United States
GSK Investigational Site, Sarasota, Florida, United States
GSK Investigational Site, Tampa, Florida, United States
GSK Investigational Site, Atlanta, Georgia, 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, Boston, Massachusetts, United States
GSK Investigational Site, Boston, Massachusetts, United States
GSK Investigational Site, Burlington, Massachusetts, United States
GSK Investigational Site, Minneapolis, Minnesota, United States
GSK Investigational Site, Minneapolis, Minnesota, United States
GSK Investigational Site, Rochester, Minnesota, United States
GSK Investigational Site, Morristown, New Jersey, United States
GSK Investigational Site, Farmington, New Mexico, United States
GSK Investigational Site, Lake Success, New York, United States
GSK Investigational Site, New York, 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, Vancouver, Oregon, United States
GSK Investigational Site, Abington, Pennsylvania, United States
GSK Investigational Site, Philadelphia, 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, The Woodlands, Texas, United States
GSK Investigational Site, Graz, , Austria
GSK Investigational Site, Innsbruck, , Austria
GSK Investigational Site, Wien, , Austria
GSK Investigational Site, Edegem, , Belgium
GSK Investigational Site, Kortrijk, , Belgium
GSK Investigational Site, Leuven, , Belgium
GSK Investigational Site, Liège, , Belgium
GSK Investigational Site, Calgary, Alberta, Canada
GSK Investigational Site, Kelowna, British Columbia, Canada
GSK Investigational Site, Vancouver, British Columbia, 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, Sherbrooke, Quebec, Canada
GSK Investigational Site, Aalborg, , Denmark
GSK Investigational Site, Copenhagen, , Denmark
GSK Investigational Site, Herlev, , Denmark
GSK Investigational Site, Odense, , Denmark
GSK Investigational Site, Besançon Cedex, , France
GSK Investigational Site, Lille, , France
GSK Investigational Site, Montpellier Cedex 5, , France
GSK Investigational Site, Nice, , France
GSK Investigational Site, Saint Brieuc, , France
GSK Investigational Site, Saint-Herblain cedex, , France
GSK Investigational Site, Heidelberg, Baden-Wuerttemberg, Germany
GSK Investigational Site, Muenchen, Bayern, Germany
GSK Investigational Site, Goettingen, Niedersachsen, Germany
GSK Investigational Site, Hannover, Niedersachsen, Germany
GSK Investigational Site, Duesseldorf, Nordrhein-Westfalen, Germany
GSK Investigational Site, Essen, Nordrhein-Westfalen, Germany
GSK Investigational Site, Essen, Nordrhein-Westfalen, Germany
GSK Investigational Site, Dresden, Sachsen, Germany
GSK Investigational Site, Kiel, Schleswig-Holstein, Germany
GSK Investigational Site, Berlin, , Germany
GSK Investigational Site, Hamburg, , Germany
GSK Investigational Site, Szolnok, , Hungary
GSK Investigational Site, Haifa, , Israel
GSK Investigational Site, Holon, , Israel
GSK Investigational Site, Jerusalem, , Israel
GSK Investigational Site, Jerusalem, , Israel
GSK Investigational Site, Kfar-Saba, , Israel
GSK Investigational Site, Rehovot, , Israel
GSK Investigational Site, Tel Aviv, , Israel
GSK Investigational Site, Tel Hashomer, , Israel
GSK Investigational Site, Roma, Lazio, Italy
GSK Investigational Site, Brescia, Lombardia, Italy
GSK Investigational Site, Milano, Lombardia, Italy
GSK Investigational Site, Catania, Sicilia, Italy
GSK Investigational Site, MIlano, , Italy
GSK Investigational Site, Bergen, , Norway
GSK Investigational Site, Oslo, , Norway
GSK Investigational Site, Bialystok, , Poland
GSK Investigational Site, Gdansk, , Poland
GSK Investigational Site, Lodz, , Poland
GSK Investigational Site, Poznan, , Poland
GSK Investigational Site, Oviedo, Asturias, Spain
GSK Investigational Site, Barcelona, , Spain
GSK Investigational Site, Barcelona, , Spain
GSK Investigational Site, Madrid, , Spain
GSK Investigational Site, Madrid, , Spain
GSK Investigational Site, Madrid, , Spain
GSK Investigational Site, Palma de Mallorca, , Spain
GSK Investigational Site, Linköping, , Sweden
GSK Investigational Site, Lund, , Sweden
GSK Investigational Site, Stockholm, , Sweden
GSK Investigational Site, Nottingham, Nottinghamshire, United Kingdom
GSK Investigational Site, Yeovil, Somerset, United Kingdom
GSK Investigational Site, Birmingham, West Midlands, United Kingdom
GSK Investigational Site, Bebington, Wirral, , United Kingdom
GSK Investigational Site, London, , United Kingdom
GSK Investigational Site, London, , United Kingdom
GSK Investigational Site, London, , United Kingdom
GSK Investigational Site, London, , United Kingdom
GSK Investigational Site, Maidstone, , United Kingdom
GSK Investigational Site, Rhyl, , United Kingdom
GSK Investigational Site, Taunton, , United Kingdom
Contact Details
Name: GSK Clinical Studies
Affiliation: GlaxoSmithKline
Role: STUDY_DIRECTOR
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