Spots Global Cancer Trial Database for A Study of Oral AMN107 in Adults With Chronic Myelogenous Leukemia (CML) or Other Hematologic Malignancies
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Trial Identification
Brief Title: A Study of Oral AMN107 in Adults With Chronic Myelogenous Leukemia (CML) or Other Hematologic Malignancies
Official Title: A Phase IA/II Multicenter, Dose-escalation Study of Oral AMN107 on a Continuous Daily Dosing Schedule in Adult Patients With Imatinib-resistant/Intolerant CML in Chronic or Accelerated Phase or Blast Crisis, Relapsed/Refractory Ph+ ALL, and Other Hematologic Malignancies.
Study ID: NCT00109707
Interventions
Study Description
Brief Summary: The purpose of this trial is to assess the efficacy, safety, tolerability, biologic activity, and pharmacokinetics of AMN107 in six groups of patients with one of the following conditions: Relapsed/refractory Ph+ Acute lymphoblastic leukemia (ALL) (arm 1) Group A - Imatinib failure only (arms 2, 3 and 4) * imatinib-resistant or intolerant CML - Chronic Phase (CP) * imatinib-resistant or intolerant CML - Accelerated Phase (AP) * imatinib-resistant or intolerant CML - Blast Crisis (BC) Group B - Imatinib and other TKI failure (arms 2, 3 and 4) * imatinib-resistant or intolerant CML - Chronic Phase (CP) * imatinib-resistant or intolerant CML - Accelerated Phase (AP) * imatinib-resistant or intolerant CML - Blast Crisis (BC) Hypereosinophilic syndrome/chronic eosinophilic leukemia (HES/CEL) (arm 5) Systemic mastocytosis (Sm) (arm 6)
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope National Medical Center, Duarte, California, United States
Stanford University Medical Center, Stanford, California, United States
University of Colorado Hospital, Aurora, Colorado, United States
H. Lee Moffitt Cancer Center & Research Institute Dept.of H. Lee Moffitt, Tampa, Florida, United States
University of Chicago Medical Center Dept. of U. of Chicago Hosp(3), Chicago, Illinois, United States
University of Illinois at Chicago Divisionof Hematology/Oncology, Chicago, Illinois, United States
Indiana Blood and Marrow Institute Dept of Indiana Blood&Mar (2), Beech Grove, Indiana, United States
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins Med. Div.of Hematologic Malignancie, Baltimore, Maryland, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan Health System Clinical Trials Office, Ann Arbor, Michigan, United States
Wayne State University, Detroit, Michigan, United States
Mayo Clinic - Rochester, Rochester, Minnesota, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Roswell Park Cancer Institute Rosewell SC, Buffalo, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
University of Rochester Medical Center, Rochester, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina, United States
Oregon Health Sciences University, Portland, Oregon, United States
The Jones Clinic, Germantown, Tennessee, United States
Vanderbilt University Medical Center, Clinical Trials Center Investigational Drug Services, Nashville, Tennessee, United States
MD Anderson Cancer Center/University of Texas, Houston, Texas, United States
Swedish Cancer Institute, Seattle, Washington, United States
Novartis Investigative Site, St. Leonards, New South Wales, Australia
Novartis Investigative Site, Adelaide, South Australia, Australia
Novartis Investigative Site, Prahran, Victoria, Australia
Novartis Investigative Site, Wien, , Austria
Novartis Investigative Site, Bruxelles, , Belgium
Novartis Investigative Site, Haine-saint-Paul, , Belgium
Novartis Investigative Site, Leuven, , Belgium
Novartis Investigative Site, Yvoir, , Belgium
Novartis Investigative Site, Vancouver, British Columbia, Canada
Novartis Investigative Site, Toronto, Ontario, Canada
Novartis Investigative Site, Montreal, Quebec, Canada
Novartis Investigative Site, Montreal, Quebec, Canada
Novartis Investigative Site, Vejle, , Denmark
Novartis Investigative Site, HUS Helsinki, , Finland
Novartis Investigative Site, Bordeaux Cedex, , France
Novartis Investigative Site, Créteil, , France
Novartis Investigative Site, Dijon, , France
Novartis Investigative Site, Lille, , France
Novartis Investigative Site, Limoges cedex, , France
Novartis Investigative Site, Lyon, , France
Novartis Investigative Site, Marseille, , France
Novartis Investigative Site, Poitiers, , France
Novartis Investigative Site, Rennes, , France
Novartis Investigative Site, Vandoeuvre les Nancy, , France
Novartis Investigative Site, Berlin, , Germany
Novartis Investigative Site, Duesseldorf, , Germany
Novartis Investigative Site, Frankfurt/M, , Germany
Novartis Investigative Site, Hamburg, , Germany
Novartis Investigative Site, Leipzig, , Germany
Novartis Investigative Site, Mainz, , Germany
Novartis Investigative Site, Mannheim, , Germany
Novartis Investigative Site, Muenchen, , Germany
Novartis Investigative Site, Pokfulam, , Hong Kong
Novartis Investigative Site, Bergamo, BG, Italy
Novartis Investigative Site, Bologna, BO, Italy
Novartis Investigative Site, Genova, GE, Italy
Novartis Investigative Site, Monza, MB, Italy
Novartis Investigative Site, Milano, MI, Italy
Novartis Investigative Site, Pescara, PE, Italy
Novartis Investigative Site, Pavia, PV, Italy
Novartis Investigative Site, Reggio Calabria, RC, Italy
Novartis Investigative Site, Roma, RM, Italy
Novartis Investigative Site, Roma, RM, Italy
Novartis Investigative Site, Roma, RM, Italy
Novartis Investigative Site, Orbassano, TO, Italy
Novartis Investigative Site, Napoli, , Italy
Novartis Investigative Site, Hwasun-gun, Jeollanam-do, Korea, Republic of
Novartis Investigative Site, Seoul, Korea, Korea, Republic of
Novartis Investigative Site, Seoul, Korea, Korea, Republic of
Novartis Investigative Site, Taegu, , Korea, Republic of
Novartis Investigative Site, Amsterdam, , Netherlands
Novartis Investigative Site, Rotterdam, , Netherlands
Novartis Investigative Site, Grafton, Auckland, New Zealand
Novartis Investigative Site, Oslo, , Norway
Novartis Investigative Site, Katowice, , Poland
Novartis Investigative Site, Lodz, , Poland
Novartis Investigative Site, Warszawa, , Poland
Novartis Investigative Site, Warszawa, , Poland
Novartis Investigative Site, Wroclaw, , Poland
Novartis Investigative Site, Singapore, , Singapore
Novartis Investigative Site, Barcelona, Catalunya, Spain
Novartis Investigative Site, Hospitalet de LLobregat, Catalunya, Spain
Novartis Investigative Site, Göteborg, , Sweden
Novartis Investigative Site, Linköping, , Sweden
Novartis Investigative Site, Lund, , Sweden
Novartis Investigative Site, Uppsala, , Sweden
Novartis Investigative Site, Basel, , Switzerland
Novartis Investigative Site, Genève, , Switzerland
Novartis Investigative Site, Niaosong Township, , Taiwan
Novartis Investigative Site, Birmingham, , United Kingdom
Novartis Investigative Site, Cambridge, , United Kingdom
Novartis Investigative Site, Glasgow - Scotland, , United Kingdom
Novartis Investigative Site, Leeds, , United Kingdom
Novartis Investigative Site, Liverpool, , United Kingdom
Novartis Investigative Site, London, , United Kingdom
Novartis Investigative Site, London, , United Kingdom
Novartis Investigative Site, Newcastle upon Tyne, , United Kingdom
Contact Details
Name: Novartis Pharmaceuticlas
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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