Study Evaluating SKI-606 (Bosutinib) In Philadelphia Chromosome Positive Leukemias



Status:Completed
Conditions:Other Indications, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology, Other
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:March 2006
End Date:July 2015

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase 1/2 Study Of Bosutinib (SKI-606) In Philadelphia Chromosome Positive Leukemias

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.


Inclusion Criteria:

- Ph+ CML or Ph+ ALL who are primarily refractory to full-dose imatinib (600 mg), have
disease progression/relapse while on full-dose imatinib, or are intolerant of any
dose of imatinib.

- At least 3 months post stem cell transplantation

- Able to take daily oral capsules/tablets reliably

Exclusion Criteria:

- Subjects with Philadelphia chromosome, and bcr-abl negative CML

- Overt leptomeningeal leukemia

- Subjects without evidence of leukemia in bone marrow (extramedullary disease only)
We found this trial at
35
sites
Penn State Milton S. Hershey Medical Center
500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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Roswell Park Cancer Institute
666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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Buffalo, NY
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Virginia Commonwealth University Massey Cancer Center
401 College Street
Richmond, Virginia 23298
(804) 828-0450
Virginia Commonwealth University Massey Cancer Center Founded in 1974, VCU Massey Cancer Center is a...
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Richmond, VA
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The Emory Clinic
Atlanta, Georgia 30322
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Atlanta, GA
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Emory University Hospital
1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Emory University Hospital As the largest health care system in Georgia and the only health...
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Atlanta, GA
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Investigational Drug Service (Drug Ship)
Atlanta, Georgia 30322
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Atlanta, GA
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Winship Cancer Institute
Atlanta, Georgia 30322
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Atlanta, GA
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University of Maryland Medical Center
22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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Baltimore, MD
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University of Maryland
Baltimore, Maryland 20742
(301) 405-1000
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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Baltimore, MD
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Rocky Mountain Cancer Center
Denver, Colorado 80218
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Denver, CO
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Hospital Universitario Austral
Derqui-Pilar, Buenos Aires
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Derqui-Pilar,
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City of Hope National Medical Center
1500 East Duarte Road
Duarte, California 91010
626-256-HOPE (4673)
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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Duarte, CA
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City of Hope
Duarte, California 91010
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Duarte, CA
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Hudson Valley Hematology and Oncology Associates
Hawthorne, New York 10532
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Hawthorne, NY
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Westchester Oncology Hematology Group, P.C.
Hawthorne, New York 10532
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Hawthorne, NY
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M.D. Anderson Cancer Center
Houston, Texas 77030
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Houston, TX
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The University Of Texas
Houston, Texas 77030
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Houston, TX
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Franciscan St. Francis Health, Site
Indianapolis, Indiana 46237
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Indianapolis, IN
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Indiana Blood and Marrow Transplantation Research-Franciscan St Francis Health Center Inc.
Indianapolis, Indiana 46237
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Indianapolis, IN
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Indiana Blood and Marrow Transplantation Research
Indianapolis, Indiana 46237
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Indianapolis, IN
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New York Presbyterian Hospital (Cornell)
New York, New York 10021
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New York, NY
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New York-Presbyterian Hospital
New York, New York 10032
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New York, NY
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Weill Cornell Medical Center
New York, New York 10065
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Weill-Cornell Medical College
New York, New York 10021
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New York, NY
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Oncology Specialists, S.C.
Niles, Illinois 60714
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Niles, IL
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Oncology Specialists, SC
Park Ridge, Illinois 60068
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Park Ridge, IL
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University of Rochester Cancer Center Pharmacy
Rochester, New York 14642
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Rochester, NY
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University of Rochester Medical Center Strong Memorial Hospital - James P. Wilmot Cancer Center
Rochester, New York 14642
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Rochester, NY
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LSU Health Sciences Center
Shreveport, Louisiana
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Shreveport, LA
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Louisiana State University Health Sciences Center, Feist-Weiller Cancer Center
Shreveport, Louisiana 71130
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Shreveport, LA
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Westchester Medical Center
Valhalla, New York 10595
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Valhalla, NY
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Georgetown University Medical Center
3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 687-7695
Georgetown University Medical Center Georgetown University Medical Center is committed to excellence in research, education...
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Washington,
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Georgetown University Hospital
3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 444-2000
Georgetown University Hospital MedStar Georgetown University Hospital is a not-for-profit, acute-care teaching and research hospital...
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Washington,
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Lombardi Cancer Center
Washington, District of Columbia 20007
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Washington,
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The George Washington University Medical Faculty Associates (Gwmfa)
Washington, District of Columbia 20037
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Washington,
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