BMS-582664 in Combination With Erbitux in Patients With Advanced Gastrointestinal Malignancies
NCT ID: NCT00207051
Last Updated: 2011-01-25
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
62 participants
INTERVENTIONAL
2006-01-31
2008-12-31
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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1
Brivanib + Cetuximab
Tablets/IV, Oral/IV , Brivanib 800 mg + Erbitux 400 mg/m2 X 1, followed by 250mg/m2, Brivanib QD / Erbitux QW, up to 48 weeks
Interventions
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Brivanib + Cetuximab
Tablets/IV, Oral/IV , Brivanib 800 mg + Erbitux 400 mg/m2 X 1, followed by 250mg/m2, Brivanib QD / Erbitux QW, up to 48 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Feeling well other than cancer diagnosis (ie lab work, no infection, etc)
* Available tumor tissue sample from prior surgery
* Measurable disease on scans
* 4-6 weeks since prior therapy and recovered from the effects of prior therapy
* Men and women, ages 18 and above
* Women must not be pregnant or breastfeeding
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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Usc/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Georgetn Univ Lombardi Can Ctr
Washington D.C., District of Columbia, United States
University Of Miami Miller School Of Medicine
Miami, Florida, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Local Institution
Hamilton, Ontario, Canada
Local Institution
Toronto, Ontario, Canada
Local Institution
Amsterdam, , Netherlands
Countries
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References
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Jonker DJ, Rosen LS, Sawyer MB, de Braud F, Wilding G, Sweeney CJ, Jayson GC, McArthur GA, Rustin G, Goss G, Kantor J, Velasquez L, Syed S, Mokliatchouk O, Feltquate DM, Kollia G, Nuyten DSA, Galbraith S. A phase I study to determine the safety, pharmacokinetics and pharmacodynamics of a dual VEGFR and FGFR inhibitor, brivanib, in patients with advanced or metastatic solid tumors. Ann Oncol. 2011 Jun;22(6):1413-1419. doi: 10.1093/annonc/mdq599. Epub 2010 Dec 3.
Related Links
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Investigator Inquiry form
Other Identifiers
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CA182-003
Identifier Type: -
Identifier Source: org_study_id
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