Advanced Chronic Myelogenous Leukemia (CML) - Follow On: Study of BMS-354825 in Subjects With CML
NCT ID: NCT00123487
Last Updated: 2014-11-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
638 participants
INTERVENTIONAL
2005-06-30
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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dasatinib Twice a Day (BID)
70 mg dasatinib twice a day (BID)
dasatinib
Tablets, Oral, 140 mg QD, indefinitely, survival study
dasatinib Once a Day (QD)
140 mg dasatinib once a day (QD)
dasatinib
Tablets, Oral, 70 mg BID, indefinitely, survival study
Interventions
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dasatinib
Tablets, Oral, 70 mg BID, indefinitely, survival study
dasatinib
Tablets, Oral, 140 mg QD, indefinitely, survival study
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Men and women, 18 years of age or older
* Adequate hepatic function
* Adequate renal function
* Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month before and at least 3 months after the study in such a manner that the risk of pregnancy is minimized
* Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 2
Exclusion Criteria
* A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy
* Uncontrolled or significant cardiovascular disease
* Medications that increase bleeding risk
* Medications that change heart rhythms
* Dementia or altered mental status that would prohibit the understanding or rendering of informed consent
* History of significant bleeding disorder unrelated to CML
* Concurrent incurable malignancy other than CML
* Evidence of organ dysfunction or digestive dysfunction that would prevent administration of study therapy
* Prior therapy with BMS-35425
* Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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University Of Alabama At Birmingham
Birmingham, Alabama, United States
Loma Linda University Cancer Center
Loma Linda, California, United States
Ucla Dept. Of Medicine
Los Angeles, California, United States
Washington Cancer Institute At Washington Hospital Center
Washington D.C., District of Columbia, United States
University Of Miami
Miami, Florida, United States
Emory University School Of Medicine
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
The University Of Chicago
Chicago, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
University Of Kentucky
Lexington, Kentucky, United States
University Of Maryland
Baltimore, Maryland, United States
Dana Faber Cancer Institute
Boston, Massachusetts, United States
Karmanos Cancer Center
Detroit, Michigan, United States
Washington University School Of Medicine
St Louis, Missouri, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
Devetten, Marcel
Omaha, Nebraska, United States
The Cancer Center At Hackensack University Medical Center
Hackensack, New Jersey, United States
The Cancer Institute Of New Jersey
New Brunswick, New Jersey, United States
New York Presbyterian Hospital
New York, New York, United States
The University Of North Carolina At Chapel Hill
Chapel Hill, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Oregon Health & Sci Univ
Portland, Oregon, United States
Western Pennsylvania Cancer Institute
Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
The University Of Texas Md Anderson Cancer Center
Houston, Texas, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Local Institution
Capital Federal, Buenos Aires, Argentina
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St Leonards, New South Wales, Australia
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South Brisbane, Queensland, Australia
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Adelaide, South Australia, Australia
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Parkville, Victoria, Australia
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Perth, Western Australia, Australia
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Vienna, , Austria
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B-leuven, , Belgium
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Bruges, , Belgium
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Brussels, , Belgium
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Charleroi, , Belgium
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Yvoir, , Belgium
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Curitiba, Paraná, Brazil
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Campinas, São Paulo, Brazil
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Morumbi, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Rio de Janeiro, , Brazil
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Montreal, Quebec, Canada
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Brno, , Czechia
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Prague, , Czechia
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Aarhus C, Denmark, Denmark
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Herlev, , Denmark
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Odense C, , Denmark
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Helsinki, , Finland
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Caen, , France
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Créteil, , France
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Grenoble, , France
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Lille, , France
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Lyon, , France
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Marseille, , France
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Nantes, , France
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Paris, , France
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Pessac, , France
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Poitiers, , France
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Strasbourg, , France
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Dresden, , Germany
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Frankfurt, , Germany
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Hamburg, , Germany
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Leipzig, , Germany
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Mainz, , Germany
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Mannheim, , Germany
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Athens, , Greece
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Budapest, , Hungary
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Dublin, , Ireland
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Ramat Gan, , Israel
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Bari, , Italy
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Bologna, , Italy
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Monza, , Italy
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Napoli, , Italy
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Orbassano (to), , Italy
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Roma, , Italy
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Rotterdam, , Netherlands
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Trondheim, , Norway
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Lima, Lima Province, Peru
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Jesus Maria, Lima region, Peru
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Quezon City, , Philippines
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Gdansk, , Poland
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Katowice, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Warsaw, , Poland
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Moscow, , Russia
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Saint Petersburg, , Russia
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Singapore, , Singapore
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Bloemfontein, Free State, South Africa
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Groenkloof, Gauteng, South Africa
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Parktown, Gauteng, South Africa
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Observatory, Western Cape, South Africa
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Jeollanam-do, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Barcelona, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Valencia, , Spain
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Lund, , Sweden
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Stockholm, , Sweden
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Umeå, , Sweden
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Uppsala, , Sweden
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Basel, , Switzerland
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Bangkok, , Thailand
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London, Greater London, United Kingdom
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Glasgow, Scotland, United Kingdom
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Newcastle, Tyne and Wear, United Kingdom
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Edinburgh, , United Kingdom
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Liverpool, , United Kingdom
Countries
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References
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Chu SC, Tang JL, Li CC. Dasatinib in chronic myelogenous leukemia. N Engl J Med. 2006 Sep 7;355(10):1062-3; author reply 1063-4. No abstract available.
Lilly MB, Ottmann OG, Shah NP, Larson RA, Reiffers JJ, Ehninger G, Muller MC, Charbonnier A, Bullorsky E, Dombret H, Brigid Bradley-Garelik M, Zhu C, Martinelli G. Dasatinib 140 mg once daily versus 70 mg twice daily in patients with Ph-positive acute lymphoblastic leukemia who failed imatinib: Results from a phase 3 study. Am J Hematol. 2010 Mar;85(3):164-70. doi: 10.1002/ajh.21615.
Kantarjian H, Cortes J, Kim DW, Dorlhiac-Llacer P, Pasquini R, DiPersio J, Muller MC, Radich JP, Khoury HJ, Khoroshko N, Bradley-Garelik MB, Zhu C, Tallman MS. Phase 3 study of dasatinib 140 mg once daily versus 70 mg twice daily in patients with chronic myeloid leukemia in accelerated phase resistant or intolerant to imatinib: 15-month median follow-up. Blood. 2009 Jun 18;113(25):6322-9. doi: 10.1182/blood-2008-11-186817. Epub 2009 Apr 15.
Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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CA180-035
Identifier Type: -
Identifier Source: org_study_id
NCT00331396
Identifier Type: -
Identifier Source: nct_alias
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