Back to resultsA Study of BIBW 2992 (Afatinib) in Patients With Metastatic Colorectal Cancer
Primary Purpose
Colorectal Neoplasms
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
BIBW 2992
Cetuximab
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Neoplasms
Eligibility Criteria
Inclusion criteria:
- Patients with metastatic colorectal cancer who have failed both oxaliplatin- and irinotecan-based regimens
- Tumour sample available for KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) mutation testing and other biomarker analyses.
Exclusion criteria:
- Prior treatment with Epidermal Growth Factor Receptor (EGFR) targeting small molecules or antibodies.
- Biological treatment (including Bevacizumab or any other antiangiogenic agents) during the trial is not allowed.
- Known pre-existing interstitial lung disease.
- Planned major surgical procedures during the trial period.
Sites / Locations
- 1200.74.44001 Boehringer Ingelheim Investigational Site
- 1200.74.44005 Boehringer Ingelheim Investigational Site
- 1200.74.44006 Boehringer Ingelheim Investigational Site
- 1200.74.44003 Boehringer Ingelheim Investigational Site
- 1200.74.44009 Boehringer Ingelheim Investigational Site
- 1200.74.44012 Boehringer Ingelheim Investigational Site
- 1200.74.44007 Boehringer Ingelheim Investigational Site
- 1200.74.44013 Boehringer Ingelheim Investigational Site
- 1200.74.44011 Boehringer Ingelheim Investigational Site
- 1200.74.44010 Boehringer Ingelheim Investigational Site
- 1200.74.44008 Boehringer Ingelheim Investigational Site
- 1200.74.44004 Boehringer Ingelheim Investigational Site
- 1200.74.44002 Boehringer Ingelheim Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
BIBW 2992
Cetuximab
Arm Description
Patients receive BIBW 2992 tablets once daily
Patients receive cetuximab intravenously once a week, every week
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01152437
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 Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BIBW 2992
Arm Type
Experimental
Arm Description
Patients receive BIBW 2992 tablets once daily
Arm Title
Cetuximab
Arm Type
Active Comparator
Arm Description
Patients receive cetuximab intravenously once a week, every week
Intervention Type
Drug
Intervention Name(s)
BIBW 2992
Intervention Description
Patients receive BIBW 2992 tablets once daily, and can reduce dose for adverse event management
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Intervention Description
Patients receive cetuximab intravenously, once a week, every week
Primary Outcome Measure Information:
Title
Percentage of Participants With Objective Response
Description
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
Title
Percentage of Participants With Disease Control (DC)
Description
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
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
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
Title
Overall Survival (OS) Time
Description
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
Title
Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 8 (Cpre,ss,8)
Description
Cpre,ss,8 represents the pre-dose concentration of afatinib in plasma at steady state on day 8.
Time Frame
day 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Patients with metastatic colorectal cancer who have failed both oxaliplatin- and irinotecan-based regimens
Tumour sample available for KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) mutation testing and other biomarker analyses.
Exclusion criteria:
Prior treatment with Epidermal Growth Factor Receptor (EGFR) targeting small molecules or antibodies.
Biological treatment (including Bevacizumab or any other antiangiogenic agents) during the trial is not allowed.
Known pre-existing interstitial lung disease.
Planned major surgical procedures during the trial period.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1200.74.44001 Boehringer Ingelheim Investigational Site
City
Bournemouth
Country
United Kingdom
Facility Name
1200.74.44005 Boehringer Ingelheim Investigational Site
City
Bristol
Country
United Kingdom
Facility Name
1200.74.44006 Boehringer Ingelheim Investigational Site
City
Cambridge
Country
United Kingdom
Facility Name
1200.74.44003 Boehringer Ingelheim Investigational Site
City
Glasgow
Country
United Kingdom
Facility Name
1200.74.44009 Boehringer Ingelheim Investigational Site
City
London
Country
United Kingdom
Facility Name
1200.74.44012 Boehringer Ingelheim Investigational Site
City
Manchester
Country
United Kingdom
Facility Name
1200.74.44007 Boehringer Ingelheim Investigational Site
City
Northwood
Country
United Kingdom
Facility Name
1200.74.44013 Boehringer Ingelheim Investigational Site
City
Nottingham
Country
United Kingdom
Facility Name
1200.74.44011 Boehringer Ingelheim Investigational Site
City
Poole
Country
United Kingdom
Facility Name
1200.74.44010 Boehringer Ingelheim Investigational Site
City
Sheffield
Country
United Kingdom
Facility Name
1200.74.44008 Boehringer Ingelheim Investigational Site
City
Southampton
Country
United Kingdom
Facility Name
1200.74.44004 Boehringer Ingelheim Investigational Site
City
Sutton, Surrey
Country
United Kingdom
Facility Name
1200.74.44002 Boehringer Ingelheim Investigational Site
City
Truro
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1200/1200.74_U12-2359-01-DS.pdf
Description
Related Info
Learn more about this trial
A Study of BIBW 2992 (Afatinib) in Patients With Metastatic Colorectal Cancer
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