Spots Global Cancer Trial Database for A Study of BIBW 2992 (Afatinib) in Patients With Metastatic Colorectal Cancer
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Trial Identification
Brief Title: A Study of BIBW 2992 (Afatinib) in Patients With Metastatic Colorectal Cancer
Official Title: An Open Label, Partially Randomised Phase II Study to Investigate the Efficacy and Safety of BIBW 2992 in Patients With Metastatic Colorectal Cancer Who Never Received Prior Anti-EGFR (Epidermal Growth Factor Receptor) Treatment
Study ID: NCT01152437
Conditions
Study Description
Brief Summary: This Phase II study is open to patients with metastatic colorectal cancer who have tried but failed chemotherapy regimens containing oxaliplatin and irinotecan. Patients must not have received anti-EGFR (Epidermal Growth Factor Receptor) treatment (for example, cetuximab, panitumumab) in the past. Patients with wild-type KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) colorectal cancer will be randomised to receive either BIBW 2992 or cetuximab. Patients with KRAS mutated colorectal cancer will not be randomised, but will all receive BIBW 2992. The main objectives of the study are: to compare the effectiveness of BIBW 2992 with that of cetuximab in patients with KRAS wild type cancer, and to assess the effectiveness of BIBW 2992 in patients with KRAS mutated cancer.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
Name: Boehringer Ingelheim
Affiliation: Boehringer Ingelheim
Role: STUDY_CHAIR
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