A Study of the Alternative Administration of Ixabepilone and Vinflunine
NCT ID: NCT00362830
Last Updated: 2016-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
60 participants
INTERVENTIONAL
2006-08-31
2007-09-30
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
PARALLEL
TREATMENT
NONE
Study Groups
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1
vinflunine + ixabepilone
solution for injection, IV, vinflunine: 250 to 320 mg/m2 + ixabepilone: 30 to 40 mg/m2, every 3 wks, variable duration
Interventions
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vinflunine + ixabepilone
solution for injection, IV, vinflunine: 250 to 320 mg/m2 + ixabepilone: 30 to 40 mg/m2, every 3 wks, variable duration
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Brain mets
* Severe nerve damage
* ANC \<2,000/mm3
* Platelets \<100K
* Bilirubin \>= 1.5 times the IULN
* ALT/AST \>= 2.5 times the IULN
* Creatinine \<50 mL/min
* Prior treatment with vinflunine and/or ixabepilone
* Strong use of CYPP450 drugs
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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University Of Miami Miller School Of Medicine
Miami, Florida, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Countries
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Other Identifiers
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CA183-008
Identifier Type: -
Identifier Source: org_study_id
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