Phase I Study of Dasatinib (BMS-354825) and Capecitabine for Women With Advanced Breast Cancer
NCT ID: NCT00452673
Last Updated: 2015-03-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
52 participants
INTERVENTIONAL
2007-06-30
2012-10-31
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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50 mg BID dasatinib + 825 mg/m^2 BID capecitabine
Twice a day (BID) for 2 weeks of a 3-week cycle
Dasatinib
Tablets, Oral, 50 mg or 70 mg twice a day (BID), 100 mg once per day (QD). Treatment may continue until disease progression
Capecitabine
Tablets, Oral, 660 - 1250 mg/m\^2 twice a day (BID). Treatment may continue until disease progression.
70 mg BID dasatinib + 825 mg/m^2 BID capecitabine
BID for 2 weeks of a 3-week cycle
Dasatinib
Tablets, Oral, 50 mg or 70 mg twice a day (BID), 100 mg once per day (QD). Treatment may continue until disease progression
Capecitabine
Tablets, Oral, 660 - 1250 mg/m\^2 twice a day (BID). Treatment may continue until disease progression.
70 mg BID dasatinib + 1000 mg/m^2 BID capecitabine
BID for 2 weeks of a 3-week cycle
Dasatinib
Tablets, Oral, 50 mg or 70 mg twice a day (BID), 100 mg once per day (QD). Treatment may continue until disease progression
Capecitabine
Tablets, Oral, 660 - 1250 mg/m\^2 twice a day (BID). Treatment may continue until disease progression.
100 mg QD dasatinib + 1000 mg/m^2 BID capecitabine
2 weeks of a 3-week cycle
Dasatinib
Tablets, Oral, 50 mg or 70 mg twice a day (BID), 100 mg once per day (QD). Treatment may continue until disease progression
Capecitabine
Tablets, Oral, 660 - 1250 mg/m\^2 twice a day (BID). Treatment may continue until disease progression.
Interventions
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Dasatinib
Tablets, Oral, 50 mg or 70 mg twice a day (BID), 100 mg once per day (QD). Treatment may continue until disease progression
Capecitabine
Tablets, Oral, 660 - 1250 mg/m\^2 twice a day (BID). Treatment may continue until disease progression.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No pleural or pericardial effusion
* Not receiving anticoagulants
18 Years
FEMALE
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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City Of Hope National Medical Center
Duarte, California, United States
Northwestern University Feinberg School Of Medicine
Chicago, Illinois, United States
New York Presbyterian Hospital
New York, New York, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Local Institution
Rozzano, Milano, Italy
Local Institution
Barcelona, , Spain
Local Institution
Seville, , Spain
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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EUDRACT: 2006-006973-26
Identifier Type: -
Identifier Source: secondary_id
CA180-004
Identifier Type: -
Identifier Source: org_study_id
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