Spots Global Cancer Trial Database for (PIONEER) Study to Evaluate Efficacy and Safety of Avapritinib (BLU-285), A Selective KIT Mutation-targeted Tyrosine Kinase Inhibitor, Versus Placebo in Patients With Indolent Systemic Mastocytosis
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Trial Identification
Brief Title: (PIONEER) Study to Evaluate Efficacy and Safety of Avapritinib (BLU-285), A Selective KIT Mutation-targeted Tyrosine Kinase Inhibitor, Versus Placebo in Patients With Indolent Systemic Mastocytosis
Official Title: A 3-Part, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate Safety and Efficacy of Avapritinib (BLU-285), a Selective KIT Mutation-Targeted Tyrosine Kinase Inhibitor, in Indolent and Smoldering Systemic Mastocytosis With Symptoms Inadequately Controlled With Standard Therapy
Study ID: NCT03731260
Conditions
Study Description
Brief Summary: This is a Phase 2, randomized, double-blind, placebo-controlled study comparing the efficacy and safety of avapritinib + best supportive care (BSC) with placebo + BSC in patients with indolent systemic mastocytosis (ISM) whose symptoms are not adequately controlled by BSC. The study will be conducted in 3 parts. All patients will receive treatment with avapritinib during Part 3 including those rolling over from the placebo group.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
Mayo Clinic Hospital, Phoenix, Arizona, United States
Stanford Cancer Institute, Stanford, California, United States
Mayo Clinic Florida, Jacksonville, Florida, United States
H. Lee Moffitt Cancer Center, Tampa, Florida, United States
Winship Cancer Institute, Emory University, Atlanta, Georgia, United States
Rush University Medical Center, Chicago, Illinois, United States
University of Kansas Hospital, Kansas City, Kansas, United States
Brigham & Women's Hospital, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Michigan Medicine, University of Michigan, Ann Arbor, Michigan, United States
Mayo Clinic, Rochester, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Herbert Irving Comprehensive Cancer Center, New York, New York, United States
Duke University Health System (DUHS), Durham, North Carolina, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
University of Texas, MD Anderson Cancer Center, Houston, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Virginia Commonwealth University Medical Center, Richmond, Virginia, United States
University Hospital Antwerp, Edegem, , Belgium
Tom Baker Cancer Centre, Calgary, Alberta, Canada
University of Alberta Hospital, Edmonton, Alberta, Canada
St. Michael's Hospital, Toronto, Ontario, Canada
Odense Universitetshospital, ORCA/Allergicentret, Hudafdeling I og Allergicenter, Odense, , Denmark
Hôpital de la Timone, Service de dermatologie, Marseille, , France
Hôpital Pitié-Salpêtrière, Service de Dermatologie, Paris, , France
CHU Toulouse Larrey, CEREMAST, Service de Dermatologie et Allergologie cutanée, Toulouse, , France
Uniklinik RWTH Aachen, Aachen, , Germany
Charité Universitätsmedizin Berlin, Berlin, , Germany
University Clinic Hamburg Eppendorf, University Cancer Center Hamburg (UCCH), Hamburg, , Germany
Universitätsklinikum Schleswig-Holstein, Hämatologie/Onkologie, Lübeck, , Germany
Universitätsklinik Mainz, Universitäts-Hautklinik, Clinical Research Center, Mainz, , Germany
Universitätsmedizin Mannheim, III. Medizinische Klinik, Mannheim, , Germany
Klinikum rechts der Isar, Technische Universität München, Munich, , Germany
A.O.U di Bologna - IRCCS, Istituto di Ematologia Lorenzo e Ariosto Seragnoli, Ematologia, Bologna, , Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Poloclinico, UOC Ematologia, Milan, , Italy
A.O. OO.RR. S.Giovanni di Dio e Ruggi d'Aragona, University of Salerno, Salerno, , Italy
Azienda Ospedaliera Universitaria Integrata di Verona, Verona, , Italy
University Medical Center Groningen (UMCG), Groningen, , Netherlands
Erasmus Medical Center, Rotterdam, , Netherlands
Oslo Universitetssykehus, Rikshospitalet, Department of Hematology, Oslo, , Norway
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
lnstituto de Estudios de Mastocitosis de Castilla la Mancha, Hospital Virgen del Valle - Complejo Hospitalario de Toledo, Toledo, , Spain
Karolinska University Hospital, Hematologimottagningen R51, Stockholm, , Sweden
Akademiska sjukhuset, Hematologmottagningen/101A, Uppsala, , Sweden
University Hospital Basel, Basel, , Switzerland
NHS Greater Glasgow and Clyde, Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital, London, , United Kingdom
Clatterbridge Cancer Centre NHS Foundation Trust, Wirral, , United Kingdom
Contact Details
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