Long-term Safety of Dasatinib in Patients With Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
NCT ID: NCT00982488
Last Updated: 2016-01-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
238 participants
INTERVENTIONAL
2007-10-31
2014-12-31
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
PARALLEL
TREATMENT
NONE
Study Groups
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Dasatinib, 50 mg QD to 120 mg BID, Chronic phase
Participants with chronic phase disease continued on the previous study dose of dasatinib, ranging from 50 mg once daily (QD) to 120 mg twice daily (BID).
Dasatinib
Dasatinib was supplied as 20- and 50-mg tablets.
Imatinib, 400 mg BID, Chronic phase
Participants with chronic phase disease received 400 mg of imatinib twice BID.
Imatinib
Imatinib was supplied as 100- and 400-mg tablets.
Dasatinib, 50 mg QD to 120 mg BID, Advanced phase, AP
Participants with advanced phase disease, accelerated phase (AP), continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID.
Dasatinib
Dasatinib was supplied as 20- and 50-mg tablets.
Dasatinib, 50 mg QD to 120 mg BID, Advanced phase, MBP
Participants with advanced phase disease, myeloid blast cell (MBP), continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID.
Dasatinib
Dasatinib was supplied as 20- and 50-mg tablets.
Dasatinib, 50 mg QD to 120 mg BID, Advanced phase, Ph+ ALL
Participants with advanced phase disease, Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID.
Dasatinib
Dasatinib was supplied as 20- and 50-mg tablets.
Interventions
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Dasatinib
Dasatinib was supplied as 20- and 50-mg tablets.
Imatinib
Imatinib was supplied as 100- and 400-mg tablets.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Received treatment in protocols CA180-005, CA180-006, CA180-013, CA180-015 or CA180-017, or CA180-039
* Received clinical benefit with dasatinib or imatinib (study CA180017) in the opinion of the Investigator
* Men and women, ages 18 and older
Exclusion Criteria
* Dementia or altered mental status that would prohibit the understanding or rendering of informed consent
* Patients currently taking drugs, including but not limited to quinidine, procainamide, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, erythromycins, clarithromycin, chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, ziprasidone, cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, and lidoflazine, which are generally accepted to have a risk of causing Torsades de Pointes
* Patients taking medications known to be potent CYP3A4 inhibitors (ketoconazole, ritonavir) or inducers (rifampin, efavirenz)
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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Pacific Cancer Medical Center Inc
Anaheim, California, United States
Loma Linda University Cancer Center
Loma Linda, California, United States
Ucla Department Of Medicine
Los Angeles, California, United States
Stanford University School Of Medicine
Stanford, California, United States
Kaiser Permanente Medical Center
Vallejo, California, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
University Of Chicago
Chicago, Illinois, United States
Central Indiana Cancer Centers
Indianapolis, Indiana, United States
University Of Kansas Medical Center
Westwood, Kansas, United States
Dana Faber Cancer Institute
Boston, Massachusetts, United States
University Of Michigan Medical Center
Ann Arbor, Michigan, United States
Wayne State University
Detroit, Michigan, United States
John Theurer Cancer Center
Hackensack, New Jersey, United States
Oregon Health & Sci Univ
Portland, Oregon, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
Ut Southwestern Medical Center At Dallas
Dallas, Texas, United States
The University Of Texas Md Anderson Cancer Center
Houston, Texas, United States
Local Institution
Buenos Aires, Buenos Aires, Argentina
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Buenos Aires, Buenos Aires, Argentina
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Capital Federal, Buenos Aires, Argentina
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Adelaide, South Australia, Australia
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Mont-godinne, , Belgium
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Curitiba, Paraná, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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Campinas, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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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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Mannheim, , Germany
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Budapest, , Hungary
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Dublin, Dublin, Ireland
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Ramat Gan, , Israel
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Bologna, , Italy
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Napoli, , Italy
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Orbassano (to), , Italy
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Roma, , Italy
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Trondheim, , Norway
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Lima, Lima Province, Peru
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Lima, Lima Province, Peru
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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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Groenkloof, Gauteng, South Africa
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Parktown, Gauteng, South Africa
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Jeollanam-do, , South Korea
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Seoul, , South Korea
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Barcelona, , 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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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
Countries
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Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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2007-003624-37
Identifier Type: -
Identifier Source: secondary_id
CA180-188
Identifier Type: -
Identifier Source: org_study_id
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