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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
94
Patients receive BIBW 2992 tablets once daily, and can reduce dose for adverse event management
Patients receive cetuximab intravenously, once a week, every week
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
...and 3 more locations
Percentage of Participants With Objective Response
Percentage of participants with objective response: complete response (CR) or partial response (PR) according to RECIST (version 1.1) without confirmation criteria applied.
Time frame: Baseline till progression or death, whichever came first, assessed up to 23 months
Percentage of Participants With Disease Control (DC)
Percentage of participants with objective response or stable disease (SD) as determined by RECIST (version 1.1) with confirmation criteria applied.
Time frame: Baseline till progression or death, whichever came first, assessed up to 23 months
Progression Free Survival (PFS)
PFS time is defined as time from randomisation (wild-type group) or start of treatment (mutated group) to tumor progression evaluated according to RECIST (version 1.1) or death whichever occurs earlier. Median and confidence interval estimated using product-limit Kaplan-Meier method.
Time frame: Baseline till progression or death, whichever came first, assessed up to 23 months
Overall Survival (OS) Time
OS time is defined as time from the date of randomisation (wild-type group) or date of start of treatment (mutated group) to the date of death. Median and confidence interval estimated using product-limit Kaplan-Meier method.
Time frame: Baseline till death, assessed up to 23 months
Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 8 (Cpre,ss,8)
Cpre,ss,8 represents the pre-dose concentration of afatinib in plasma at steady state on day 8.
Time frame: day 8
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