Spots Global Cancer Trial Database for Study Evaluating SKI-606 (Bosutinib) In Philadelphia Chromosome Positive Leukemias
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Trial Identification
Brief Title: Study Evaluating SKI-606 (Bosutinib) In Philadelphia Chromosome Positive Leukemias
Official Title: A Phase 1/2 Study Of Bosutinib (Ski-606) In Philadelphia Chromosome Positive Leukemias
Study ID: NCT00261846
Conditions
Interventions
Study Description
Brief Summary: This is an open-label, continuous daily dosing, two-part safety and efficacy study of SKI-606 (bosutinib) in Philadelphia chromosome positive leukemias (Ph+). Part 1 is a dose-escalation study in chronic phase Chronic Myelogenous Leukemia (CML) subjects to establish the maximum tolerated dose (MTD) in this subject population. Part 2 has begun after the completion of Part 1 and after a dose has been established for the compound in chronic phase subjects. Part 2 is a study of the the efficacy of 500mg daily oral SKI-606 (bosutinib) in patients with all phases of Ph+ CML and Ph+ Acute Lymphocytic Leukemia (ALL). The protocol will test the hypotheses that oral daily dosing of bosutinib at 500 mg will attain (1) Major Cytogenetic Response (MCyR) in chronic phase CML patients and (2) Overall Hematological Response (OHR) in advanced leukemia patients. Each phase of the disease will be evaluated as a separate cohort.
Detailed Description:
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
HealthONE Presbyterian, Denver, Colorado, United States
Rocky Mountain Cancer Centers, Denver, Colorado, United States
Georgetown University Hospital, Washington, D.C., District of Columbia, United States
Emory Clinic, Atlanta, Georgia, United States
Emory University Hospital, Atlanta, Georgia, United States
Winship Cancer Institute, Atlanta, Georgia, United States
Oncology Specialists, S.C., Niles, Illinois, United States
Indiana Blood and Marrow Transplantation, Indianapolis, Indiana, United States
LSU Health Sciences Center, Shreveport, Louisiana, United States
University Of Maryland Medical Center, Baltimore, Maryland, United States
University Of Maryland, Baltimore, Maryland, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Hudson Valley Hematology and Oncology Associates, Hawthorne, New York, United States
Westchester Oncology Hematology Group, P.C., Hawthorne, New York, United States
Westchester Oncology Hematology, Group, P.C., Hawthorne, New York, United States
New York Presbyterian Hospital, New York, New York, United States
New York Presbyterian Hospital, New York, New York, United States
University of Rochester Cancer Center Pharmacy, Rochester, New York, United States
University of Rochester Medical Center Strong Memorial Hospital - James P. Wilmot Cancer Center, Rochester, New York, United States
University of Rochester Medical Center, Rochester, New York, United States
University of Rochester-James P. Wilmot Cancer Center, Rochester, New York, United States
University of Rochester, Rochester, New York, United States
Westchester Medical Center, Valhalla, New York, United States
Penn State Milton S Hershey Medical Center, Hershey, Pennsylvania, United States
MD Anderson Cancer Center, Houston, Texas, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
The University of Texas, Houston, Texas, United States
Virginia Commonwealth University, Richmond, Virginia, United States
Hospital Italiano de la Plata, La Plata, Provincia de Buenos Aires, Argentina
Hospital Britanico, Buenos Aires, , Argentina
Academia Nacional de Medicina-Instituto de Investigaciones Hematologicas, Buenos Aires, , Argentina
Instituto Medico Especializado Alexander Fleming, Buenos Aires, , Argentina
Clinica del Sol, Ciudad Autonoma de Buenos Aires, , Argentina
Centro Medico S.A., Corrientes, , Argentina
Hospital Jose Ramon Vidal, Corrientes, , Argentina
Hospital universitario austral, Pcia de Buenos Aires, , Argentina
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Institute of Medical and Veterinary Science, Adelaide, , Australia
Department of Clinical Haematology and Bone Marrow Transplantation, Melbourne, , Australia
Royal Brisbane and Women's Hospital, Queensland, , Australia
Haematology and Oncology Clinics of Australia, Queensland, , Australia
Klinikum Kreuzschwestern Wels, Wels, , Austria
Hospital Brigadeiro da Secretaria de Estado da Saude de Sao Paulo, Jardim Paulista, Sao Paulo/sp - Brazil, Brazil
Centro de Estudos da Disciplina dr Hematologia da Faculdade de Medicine do ABC, Santo Andre, Sp - Brazil, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Sp Brazil, Brazil
Hospital de Clinicas - Universidade Federal do Parana, Curitiba, PR, , Brazil
Cross Cancer Institute, Edmonton, Alberta, Canada
BC Cancer Agency - Cancer Centre for the Southern Interior, Kelowna, British Columbia, Canada
CancerCare Manitoba, Winnipeg, Manitoba, Canada
University Health Network Princess Margaret Hospital, Toronto, Ontario, Canada
Sir Mortimer B. Davis, Jewish General Hospital, Montreal, Quebec, Canada
Instituto Clinico Oncologico del Sur, Temuco, , Chile
The First Hospital affiliated to the Medical School of Zhejiang University, Zhejiang, P.r China, China
Peking Union Medical College Hospital of Chinese Academy of Medical Sciences, Beijing, P.r. China, China
The Department of Hematology, The Chinese PLA General Hospital, Beijing, P.r. China, China
The Hematology Hospital of Chinese Academy of Medical Sciences, Tianjin, P.r. China, China
The Department of Hematology, Ruijin Hospital Affiliated to School of Medicine of Shanghai Jiaotong, Shanghai, , China
Hospital Pablo Tobon Uribe, Medellin, Antioquia, Colombia
Fundacion Santa Fe de Bogota, Bogota, Cundinamarca, Colombia
Biomedicum Helsinki, Helsinki, , Finland
Universitaet Mainz, Mainz, RP, Germany
University Hospital Carl Gustav Carus, Dresden, , Germany
Universitaetsklinikum Hamburg - Eppendorf, Hamburg, , Germany
Universitaetsklinikum Hamburg-Eppendorf, Hamburg, , Germany
Universitaetsklinikum Magdeburg A. oe. R., Magdeburg, , Germany
III Medizinische Klinik und Poliklinik, Mainz, , Germany
Klinikum der Johann Gutenberg Universitaet Mainz, Mainz, , Germany
Universitaet Mainz Iii. Medizinische Klinik Abteilung Fuer Haematologie, Mainz, , Germany
Universitaetsklinikum Mainz, Mainz, , Germany
III. Medizinische Klinik, Mannheim, , Germany
Pamela Youde Nethersole Eastern Hosp., Chai Wan, , Hong Kong
Queen Mary Hospital, Hong Kong, , Hong Kong
Fovarosi Onkormanyzat Egyesitett Szent Istvan es Szent Laszlo, Budapest, , Hungary
Christian Medical College, Vellore, Tamil Nadu, India
University of Bologna, Bologna, Province of Bologna, Italy
Azienda Ospedaliero - Universitaria San Luigi Gonzaga, Orbassano, Torino, Italy
AOU-S.Orsola-Malpighi - Universita degli Studi di Bologna, Bologna, , Italy
Azienda Ospedaliera San Gerardo, Monza, , Italy
The Catholic University of Korea, Seoul St. Mary Hospital, Seoul, , Korea, Republic of
Dept. of Hematology, Seoul, , Korea, Republic of
Hospital Universitario "Dr. Jose Eleuterio Gonzalez", Nuevo Leon, , Mexico
Centro Oncologico Estatal ISSEMYM, Toluca Estado de Mexico, , Mexico
VU University Medical Center, Amsterdam, , Netherlands
University Medical Center Groningen, Groningen, , Netherlands
UMCG - Pharmacy, Groningen, , Netherlands
Universitair Medisch Centrum Groningen, Groningen, , Netherlands
VUMC, The Netherlands, , Netherlands
Avd. for blodsykdommer, Trondheim, Norge, Norway
Hospital Nacional Edgardo Rebagliati Martins, Lima, , Peru
State Healthcare Institution, Sverdlovsk Regional Clinical Hospital, Ekaterinburg, , Russian Federation
Kirov Research Institute of Hematology and Blood transfusion of Roszdrav Hematology clinic, Kirov, , Russian Federation
Hematological Research Centre of RAMS, Moscow, , Russian Federation
Moscow regional Clinical Research Institute named after M.F Vladimirsky, Moscow, , Russian Federation
Rostov State Medical University of Roszdrav, Rostov-on Don, , Russian Federation
Saint Petersburg State Medical University Hematology Department, Saint Petersburg, , Russian Federation
Singapore General Hospital, Singapore, , Singapore
University of the Free State, Bloemfontein, , South Africa
University of Cape Town, Cape Town, , South Africa
Johannesburg Hospital, Parktown, , South Africa
Clinical Haematology Unit, Soweto, , South Africa
Hospital Clinic de Barcelona (Hospital Clinic i Provincial), Barcelona, Catalonia, Spain
Hospital Universitari Clinic de Barcelona, Barcelona, Catalonia, Spain
Hospital Universitario La Princesa, Madrid, , Spain
Hospital Clinico Universitario de Valencia (CHUV), Valencia, , Spain
Akademiska University Hospital, Uppsala, , Sweden
National Taiwan University Hospital - Section of Hematology-Oncology, Taipei 100, , Taiwan
Northern Centre for Cancer Care - The Newcastle Upon Tyne Hospitals - NHS Foundation Trust, Newcastle Upon Tyne, North East England, United Kingdom
School of Clinical and Laboratory Sciences, University upon Tyne, North East England, United Kingdom
Hammersmith Hospital, London, , United Kingdom
Clinical Research Facility, Newcastle Upon Tyne, North East England, , United Kingdom
Contact Details
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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