A Phase I Study of Ixabepilone in Combination With Capecitabine in Japanese Patients With Metastatic Breast Cancer
NCT ID: NCT00568022
Last Updated: 2016-03-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
9 participants
INTERVENTIONAL
2008-02-29
2010-01-31
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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Ixabepilone + Capecitabine
Ixabepilone
Ixabepilone: Intravenous (IV) Solution, IV, 32(40)mg/m\^2, once every 3 weeks, up to 6 cycles
Capecitabine
Capecitabine: Tablets, Oral, 1650(2000)mg/m\^2, twice daily for 2 weeks, one week off, up to 6 cycles
Interventions
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Ixabepilone
Ixabepilone: Intravenous (IV) Solution, IV, 32(40)mg/m\^2, once every 3 weeks, up to 6 cycles
Capecitabine
Capecitabine: Tablets, Oral, 1650(2000)mg/m\^2, twice daily for 2 weeks, one week off, up to 6 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed diagnosis of adenocarcinoma originating in the breast
Exclusion Criteria
20 Years
FEMALE
No
Sponsors
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R-Pharm
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
Matsuyama, Ehime, Japan
Local Institution
Maebashi, Gunma, Japan
Local Institution
Osaka, Osaka, Japan
Local Institution
Sunto-Gun, Shizuoka, Japan
Countries
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Related Links
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Investigator Inquiry form
Other Identifiers
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CA163-117
Identifier Type: -
Identifier Source: org_study_id
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