A Study of BIBW 2992 (Afatinib) in Patients With Metastatic Colorectal Cancer

Colorectal Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01152437
• Other study ID #: 1200.74
• Secondary ID: 2009-011996-59
• Status: Completed
• Phase: Phase 2
• First received: June 28, 2010
• Last updated: May 27, 2014
• Start date: June 2010

Study information

• Verified date: May 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

1. Patients with metastatic colorectal cancer who have failed both oxaliplatin- and irinotecan-based regimens

2. Tumour sample available for KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) mutation testing and other biomarker analyses.

Exclusion criteria:

1. Prior treatment with Epidermal Growth Factor Receptor (EGFR) targeting small molecules or antibodies.

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline till progression or death, whichever came first, assessed up to 23 months	No
Primary	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.	Baseline till progression or death, whichever came first, assessed up to 23 months	No
Secondary	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.	Baseline till progression or death, whichever came first, assessed up to 23 months	No
Secondary	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.	Baseline till death, assessed up to 23 months	No
Secondary	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.	day 8	No