A Study of BIBW 2992 (Afatinib) in Patients With Metastatic Colorectal Cancer
NCT ID: NCT01152437
Last Updated: 2014-06-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
94 participants
INTERVENTIONAL
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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BIBW 2992
Patients receive BIBW 2992 tablets once daily
BIBW 2992
Patients receive BIBW 2992 tablets once daily, and can reduce dose for adverse event management
Cetuximab
Patients receive cetuximab intravenously once a week, every week
Cetuximab
Patients receive cetuximab intravenously, once a week, every week
Interventions
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BIBW 2992
Patients receive BIBW 2992 tablets once daily, and can reduce dose for adverse event management
Cetuximab
Patients receive cetuximab intravenously, once a week, every week
Eligibility Criteria
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Inclusion Criteria
2. Tumour sample available for KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) mutation testing and other biomarker analyses.
Exclusion Criteria
2. Biological treatment (including Bevacizumab or any other antiangiogenic agents) during the trial is not allowed.
3. Known pre-existing interstitial lung disease.
4. Planned major surgical procedures during the trial period.
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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1200.74.44001 Boehringer Ingelheim Investigational Site
Bournemouth, , United Kingdom
1200.74.44005 Boehringer Ingelheim Investigational Site
Bristol, , United Kingdom
1200.74.44006 Boehringer Ingelheim Investigational Site
Cambridge, , United Kingdom
1200.74.44003 Boehringer Ingelheim Investigational Site
Glasgow, , United Kingdom
1200.74.44009 Boehringer Ingelheim Investigational Site
London, , United Kingdom
1200.74.44012 Boehringer Ingelheim Investigational Site
Manchester, , United Kingdom
1200.74.44007 Boehringer Ingelheim Investigational Site
Northwood, , United Kingdom
1200.74.44013 Boehringer Ingelheim Investigational Site
Nottingham, , United Kingdom
1200.74.44011 Boehringer Ingelheim Investigational Site
Poole, , United Kingdom
1200.74.44010 Boehringer Ingelheim Investigational Site
Sheffield, , United Kingdom
1200.74.44008 Boehringer Ingelheim Investigational Site
Southampton, , United Kingdom
1200.74.44004 Boehringer Ingelheim Investigational Site
Sutton, Surrey, , United Kingdom
1200.74.44002 Boehringer Ingelheim Investigational Site
Truro, , United Kingdom
Countries
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Other Identifiers
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2009-011996-59
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1200.74
Identifier Type: -
Identifier Source: org_study_id
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