Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2009-05-31
2011-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Escalation and Expansion
Ixabepilone
Escalation: Solution, intravenous (IV), 32-40 mg/m2, every 3 weeks, approximately 6 months
Cisplatin
Escalation: Solution, IV, 60-100 mg/m2, every 3 weeks, approximately 6 months
Ixabepilone
Expansion: Solution, IV, 32 mg/m2, every 3 weeks, approximately 6 months
Cisplatin
Expansion: Solution, IV, 60-80 mg/m2, every 3 weeks, approximately 6 months
Interventions
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Ixabepilone
Escalation: Solution, intravenous (IV), 32-40 mg/m2, every 3 weeks, approximately 6 months
Cisplatin
Escalation: Solution, IV, 60-100 mg/m2, every 3 weeks, approximately 6 months
Ixabepilone
Expansion: Solution, IV, 32 mg/m2, every 3 weeks, approximately 6 months
Cisplatin
Expansion: Solution, IV, 60-80 mg/m2, every 3 weeks, approximately 6 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion:
* More than 2 prior chemotherapy containing regimens for metastatic disease
* No prior exposure to cisplatin or ixabepilone
Expansion Phase Subjects: Advanced Non-small cell lung cancer
* Men and women age ≥ 18
Exclusion:
* No prior chemotherapy-containing regimen for metastatic disease
* No prior exposure to cisplatin or ixabepilone
18 Years
ALL
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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Georgetown University Medical Center
Washington D.C., District of Columbia, United States
The Cancer Institute Of New Jersey
New Brunswick, New Jersey, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Local Institution
Lucca, , Italy
Local Institution
Meldola (Fc), , Italy
Local Institution
Rimini, , Italy
Local Institution
Viterbo, , Italy
Countries
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Related Links
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Investigator Inquiry form
Other Identifiers
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2008-004909-34
Identifier Type: -
Identifier Source: secondary_id
CA163-177
Identifier Type: -
Identifier Source: org_study_id