A Study of BIBW 2992 (Afatinib) in Patients With Metastatic Colorectal Cancer
- Registration Number
- NCT01152437
- Lead Sponsor
- Boehringer Ingelheim
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 94
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BIBW 2992 BIBW 2992 Patients receive BIBW 2992 tablets once daily Cetuximab Cetuximab Patients receive cetuximab intravenously once a week, every week
- Primary Outcome Measures
Name Time Method Percentage of Participants With Objective Response Baseline till progression or death, whichever came first, assessed up to 23 months Percentage of participants with objective response: complete response (CR) or partial response (PR) according to RECIST (version 1.1) without confirmation criteria applied.
Percentage of Participants With Disease Control (DC) Baseline till progression or death, whichever came first, assessed up to 23 months Percentage of participants with objective response or stable disease (SD) as determined by RECIST (version 1.1) with confirmation criteria applied.
- Secondary Outcome Measures
Name Time Method Progression Free Survival (PFS) Baseline till progression or death, whichever came first, assessed up to 23 months 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.
Overall Survival (OS) Time Baseline till death, assessed up to 23 months 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.
Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 8 (Cpre,ss,8) day 8 Cpre,ss,8 represents the pre-dose concentration of afatinib in plasma at steady state on day 8.
Trial Locations
- Locations (13)
1200.74.44009 Boehringer Ingelheim Investigational Site
🇬🇧London, United Kingdom
1200.74.44005 Boehringer Ingelheim Investigational Site
🇬🇧Bristol, United Kingdom
1200.74.44003 Boehringer Ingelheim Investigational Site
🇬🇧Glasgow, United Kingdom
1200.74.44011 Boehringer Ingelheim Investigational Site
🇬🇧Poole, United Kingdom
1200.74.44004 Boehringer Ingelheim Investigational Site
🇬🇧Sutton, Surrey, United Kingdom
1200.74.44002 Boehringer Ingelheim Investigational Site
🇬🇧Truro, United Kingdom
1200.74.44008 Boehringer Ingelheim Investigational Site
🇬🇧Southampton, United Kingdom
1200.74.44013 Boehringer Ingelheim Investigational Site
🇬🇧Nottingham, United Kingdom
1200.74.44010 Boehringer Ingelheim Investigational Site
🇬🇧Sheffield, United Kingdom
1200.74.44006 Boehringer Ingelheim Investigational Site
🇬🇧Cambridge, United Kingdom
1200.74.44001 Boehringer Ingelheim Investigational Site
🇬🇧Bournemouth, United Kingdom
1200.74.44007 Boehringer Ingelheim Investigational Site
🇬🇧Northwood, United Kingdom
1200.74.44012 Boehringer Ingelheim Investigational Site
🇬🇧Manchester, United Kingdom