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Brief Title: Efficacy Study for AC220 to Treat Acute Myeloid Leukemia (AML)
Official Title: Phase 2 Open-Label, AC220 Monotherapy Efficacy (ACE) Study in Patients With Acute Myeloid Leukemia (AML) With and Without FLT3-ITD Activating Mutations
Study ID: NCT00989261
Brief Summary: AC220 will be administered as a once daily oral solution given continuously as 28-day treatment cycles, without any rest periods, until disease progression, relapse, intolerance to the drug, or elective allogeneic hematopoietic stem cell transplantation (HSCT).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of California, San Francisco, San Francisco, California, United States
Northwestern Memorial Hospital, Chicago, Illinois, United States
Rush University Medical Center, Chicago, Illinois, United States
Indiana University, Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
University of Maryland, Baltimore, Maryland, United States
Johns Hopkins Hospital, Baltimore, Maryland, United States
University of Michigan Medical Center, Ann Arbor, Michigan, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Mayo Clinic, Rochester, Minnesota, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Columbia University, New York, New York, United States
Oregon Health and Science University, Portland, Oregon, United States
Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Abramson Cancer Center, Philadelphia, Pennsylvania, United States
Clinical Trials Center, Nashville, Tennessee, United States
The Vanderbuilt Clinic, Nashville, Tennessee, United States
M.D. Anderson Cancer Center, Houston, Texas, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States
Princess Margaret Hospital, Toronto, Ontario, Canada
Institut Paoli Calmettes Centre Regional de Lutte Contre le Cancer, Marseille, Cedex 9, France
Hematologie - CHU Purpan, Toulouse, Cedex, France
Hopital Avicenne, Bobigny, , France
Centre Hospitalier Universitaire d'Angers, d'Angers, , France
Centre Hospitalier Universitaire Grenoble, Grenoble, , France
Centre Hospitalier de Versailles, Le Chesnay, , France
Hopital Claude Huriez, Lille, , France
Centre Hospitalier Universitaire Limoges, Limoges, , France
Hopital Edouard Herriot, Lyon, , France
Hopital Saint-Antoine, Paris, , France
Hopital Saint-Louis, Paris, , France
Hopital Haut-Leveque, Pessac, , France
Centre Henry Becquerel, Service d'Hematologie, Rouen, , France
Centre Hospitalier Regional Universitaire, Hopital de Hautepierre, Strasbourg, , France
Centre Hospitalier Universitaire Brabois, Vandoeuvre les Nancy, , France
Charite Campus Virchow Klinikum, Berlin, , Germany
Charite, Campus Benjamin Franklin, Berlin, , Germany
Universitatsklinikum Bonn, Bonn, , Germany
Unikliniksklinikum Carl Gustav Carus, Dresden, , Germany
Uniklinik Essen, Westdeutsches Tumorzentrum, Essen, , Germany
Klinikum der Johann Wolfgang Goethe Universitat, Frankfurt am Main, , Germany
Asklepios Klinik St Georg, Hamburg, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Universitatsklinikum Heidelberg, Heidelberg, , Germany
Universitatsklinikum Jena, Jena, , Germany
Universitatsklinikum Leipzig Selbstandige Abteilung fur Hamatologie, Leipzig, , Germany
Universitatsklinikum Magdeburg, Magdeburg, , Germany
Universitatsklinikum Mannheim, Mannheim, , Germany
Philipps-Universitat Marburg, Marburg, , Germany
Klinikum rechts der Isar, Technische Universitat Munchen, Munchen, , Germany
Universitatsklinikum Munster, Munster, , Germany
Universitatsklinikum Regensburg Abteilung fur Hamatologie, Regensburg, , Germany
Robert-Bosch-Krankenhaus GmbH, Stuttgart, , Germany
Universitatsklinikum Tubingen, Tubingen, , Germany
Universitatsklinikum Ulm, Ulm, , Germany
Universitatsklinikum Wurzburg, Wurzburg, , Germany
Instituto Di Ematologia "L.Ea. Seragnoli", Bologna, , Italy
Unita Trapianti di Midollo Osseo per Adulti, Brescia, , Italy
Presidio Ospedaliero "A. Businco" - Centro di Riferimento Oncologico Regionale, Cagliari, , Italy
Azienda Ospedaliera-Universitaria Vittorio Emanuele-Ferrarotto, Catania, , Italy
Azienda Ospedaliera Universitaria San Martino, Genova, , Italy
Farmacia Ospidaliera, Orbassano, , Italy
Ospedale Civile S. Maria delle Croci, Ravenna, , Italy
Ospedale Sant Eugenio, Roma, , Italy
Universita Degli Studi di Roma Tor Vergata, Roma, , Italy
Azienda Ospedaliero Universitaria Senese, Siena, , Italy
Azienda Ospedaliero Universitaria S. Maria della Misericordia di Udine, Clinica Ematologica, Udine, , Italy
University Medical Center Groningen, Groningen, , Netherlands
Utrecht University Medical Centre, Dept. of Hematology, Utrecht, , Netherlands
Dolnoslaskie Centrum Transplantacji Komorkowych z, Wroclaw, , Poland
Clinica Universidad de Navarra, Pamplona, Navarra, Spain
Hospital Clinic i Provincial de Barcelona, Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Institut Catala d'Oncologia del Hospital Universitari Germans, Barcelona, , Spain
Instituto Catalan de Oncologia-Hospital Universitari de Girona, Girona, , Spain
Hospital de la Princesa, Servicio de Hematologia, Madrid, , Spain
Hospital General Universitario Gregorio Maranon, Madrid, , Spain
Hospital Universitario de Salamanca, Hospital Clinico, Servicio de Hematologia, Salamanca, , Spain
Hospital La Fe, Servicio de Hematologia, Valencia, , Spain
Addenbrook's Hospital, Cambridge, , United Kingdom
Castle Hill Hospital, Cottingham, , United Kingdom
Saint James University Hospital, Institute of Oncology, Leeds, , United Kingdom
Hanmmersmith Hospital, Dept. of Hematology, London, , United Kingdom
Nottingham University Hospitals NHS Trust, Nottingham, , United Kingdom
Name: Interim Chief Medical Officer
Affiliation: Ambit Biosciences Corporation
Role: STUDY_DIRECTOR