Dasatinib (BMS-354825) in Subjects With Myeloid Blast Phase Chronic Myeloid Leukemia Resistant to or Intolerant of Imatinib Mesylate
NCT ID: NCT00101816
Last Updated: 2010-08-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
124 participants
INTERVENTIONAL
2004-12-31
2008-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Dasatinib
Tablets, Oral, 70 mg, twice daily, Until disease progression or intolerable toxicity, switch to the roll-over study or study closure.
Interventions
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Dasatinib
Tablets, Oral, 70 mg, twice daily, Until disease progression or intolerable toxicity, switch to the roll-over study or study closure.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects who are either resistant or intolerant of imatinib mesylate
Exclusion Criteria
* Serious uncontrolled medical disorder or active infection
* Uncontrolled or significant heart problems, such as congestive heart failure, recent heart attack, etc
* Subjects receiving medications that may affect heart rhythm
* Other malignancy/cancer other than CML
* History of significant bleeding disorder unrelated to CML
* Pregnant or breastfeeding women (subjects must avoid becoming pregnant)
* Subjects received imatinib within 7 days, interferon or cytarabine within 14 days, a targeted anticancer medication within 14 days, an antineoplastic agent (other than hydroxyurea or anagrelide) within 28 days, or any other investigation medication in 28 days
* Subject is receiving medications that affect platelet function or an anticoagulant
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Bristol-Myers Squibb
Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
Birmingham, Alabama, United States
Local Institution
Anaheim, California, United States
Local Institution
Los Angeles, California, United States
Local Institution
Stanford, California, United States
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Vallejo, California, United States
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Denver, Colorado, United States
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Jacksonville, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Kansas City, Kansas, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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St Louis, Missouri, United States
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Hackensack, New Jersey, United States
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New Brunswick, New Jersey, United States
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New York, New York, United States
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Portland, Oregon, United States
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Pittsburgh, Pennsylvania, United States
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Nashville, Tennessee, United States
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Houston, Texas, United States
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Seattle, Washington, United States
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Adelaide, South Australia, Australia
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Vienna, , Austria
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B-Leuven, , Belgium
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Edegem, , Belgium
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Montreal, Quebec, Canada
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Aarhus, , Denmark
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Helsinki, , Finland
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Lille, , France
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Lyon, , 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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Hamburg, , Germany
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Mainz, , Germany
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Mannheim, , Germany
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Ramat Gan, , Israel
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Bologna, , Italy
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Napoli, , Italy
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Orbassano, , Italy
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Roma, , Italy
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Nijmegen, , Netherlands
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Rotterdam, , Netherlands
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Trondheim, , Norway
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Quezon City, , Philippines
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Singapore, , Singapore
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Jeollanam-Do, , South Korea
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Kyunggi-Do, , South Korea
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Seoul, , South Korea
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Gothenburg, , Sweden
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Lund, , 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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Taoyuan District, , Taiwan
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Glasgow, Central, United Kingdom
Local Institution
London, Greater London, United Kingdom
Countries
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References
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Cortes J, Rousselot P, Kim DW, Ritchie E, Hamerschlak N, Coutre S, Hochhaus A, Guilhot F, Saglio G, Apperley J, Ottmann O, Shah N, Erben P, Branford S, Agarwal P, Gollerkeri A, Baccarani M. Dasatinib induces complete hematologic and cytogenetic responses in patients with imatinib-resistant or -intolerant chronic myeloid leukemia in blast crisis. Blood. 2007 Apr 15;109(8):3207-13. doi: 10.1182/blood-2006-09-046888. Epub 2006 Dec 21.
Porkka K, Koskenvesa P, Lundan T, Rimpilainen J, Mustjoki S, Smykla R, Wild R, Luo R, Arnan M, Brethon B, Eccersley L, Hjorth-Hansen H, Hoglund M, Klamova H, Knutsen H, Parikh S, Raffoux E, Gruber F, Brito-Babapulle F, Dombret H, Duarte RF, Elonen E, Paquette R, Zwaan CM, Lee FY. Dasatinib crosses the blood-brain barrier and is an efficient therapy for central nervous system Philadelphia chromosome-positive leukemia. Blood. 2008 Aug 15;112(4):1005-12. doi: 10.1182/blood-2008-02-140665. Epub 2008 May 13.
Other Identifiers
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CA180-006
Identifier Type: -
Identifier Source: org_study_id
NCT00108719
Identifier Type: -
Identifier Source: nct_alias
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