Study of BMS-354825 (Dasatinib) in Patients With Chronic Myeloid Leukemia Who Are Either Resistant or Intolerant to Imatinib
NCT ID: NCT00101660
Last Updated: 2012-03-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
387 participants
INTERVENTIONAL
2005-02-28
2008-04-30
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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Dasatinib, 70 mg twice daily (BID)
Dasatanib, 70 mg twice daily (BID), with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
Dasatinib
Tablets; oral; 70 mg BID, depending on response
Interventions
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Dasatinib
Tablets; oral; 70 mg BID, depending on response
Eligibility Criteria
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Inclusion Criteria
* Chronic myeloid leukemia (CML)
* Previous treatment with imatinib at a dose of \>600 mg/day AND the development of progressive disease while receiving imatinib at that dose, OR
* CML with resistance to imatinib at a dose less than or equal to 600 mg/day with genetic mutation in the BCR-ABL gene that is associated with a high level of resistance to imatinib, OR
* Intolerance to imatinib at any dose
* Adequate organ function
* Women who are able to bear children must have a negative serum or urine pregnancy test. Adequate methods of contraception must be used throughout the study to avoid pregnancy for the entire interval of at least 1 month before and 3 months after completion of the study medication.
Exclusion Criteria
* Men whose sexual partners are women who are of childbearing potential, and who are unwilling or unable to use an acceptable method to avoid pregnancy of his partner for the entire study period as outlined above
* Previous diagnosis of accelerated phase or blast crisis CML.
* Participants who are eligible and willing to undergo transplantation during the screening period
* Uncontrolled or significant cardiovascular disease
* Use of imatinib within 7 days.
* Use of interferon or cytarabine within 14 days
* Use of a targeted small-molecule anticancer agent within 14 days
* Use of certain medication that carry a known side effect risk of Torsade de Pointes - Certain medications that irreversibly inhibit platelet function or anticoagulants
* Prior therapy with dasatinib.
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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Local Institution
Anaheim, California, United States
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Loma Linda, California, United States
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Los Angeles, California, United States
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Stanford, California, United States
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Vallejo, California, United States
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Hartford, Connecticut, United States
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Washington D.C., District of Columbia, 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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Indianapolis, Indiana, 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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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, 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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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Greenville, South Carolina, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Tyler, Texas, United States
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Spokane, Washington, United States
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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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East Mebourne, Victoria, Australia
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Parkville, Victoria, Australia
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Wein, , Austria
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B-Leuven, , Belgium
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Brussels, , Belgium
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Edegem, , Belgium
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Yvoir, , Belgium
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Vancouver, British Columbia, Canada
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Toronto, Ontario, Canada
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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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Leipzig, , Germany
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Mainz, , Germany
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Mannheim, , Germany
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Co Galway, Galway, Ireland
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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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Milan, , 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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Lima, Lima Province, Peru
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Singapore, , Singapore
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Parktown, Gauteng, South Africa
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Soweto, Gauteng, South Africa
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Kyunggi-Do, , South Korea
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Barcelona, , Spain
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Madrid, , Spain
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Gothenburg, , Sweden
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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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Glasgow, Central, United Kingdom
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London, Greater London, United Kingdom
Countries
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References
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Hochhaus A, Kantarjian HM, Baccarani M, Lipton JH, Apperley JF, Druker BJ, Facon T, Goldberg SL, Cervantes F, Niederwieser D, Silver RT, Stone RM, Hughes TP, Muller MC, Ezzeddine R, Countouriotis AM, Shah NP. Dasatinib induces notable hematologic and cytogenetic responses in chronic-phase chronic myeloid leukemia after failure of imatinib therapy. Blood. 2007 Mar 15;109(6):2303-9. doi: 10.1182/blood-2006-09-047266. Epub 2006 Nov 30.
Muller MC, Cortes JE, Kim DW, Druker BJ, Erben P, Pasquini R, Branford S, Hughes TP, Radich JP, Ploughman L, Mukhopadhyay J, Hochhaus A. Dasatinib treatment of chronic-phase chronic myeloid leukemia: analysis of responses according to preexisting BCR-ABL mutations. Blood. 2009 Dec 3;114(24):4944-53. doi: 10.1182/blood-2009-04-214221. Epub 2009 Sep 24.
Other Identifiers
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CA180-013
Identifier Type: -
Identifier Source: org_study_id
NCT00112801
Identifier Type: -
Identifier Source: nct_alias
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