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

May 27, 2014 updated by: Boehringer Ingelheim

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Bournemouth, United Kingdom
        • 1200.74.44001 Boehringer Ingelheim Investigational Site
      • Bristol, United Kingdom
        • 1200.74.44005 Boehringer Ingelheim Investigational Site
      • Cambridge, United Kingdom
        • 1200.74.44006 Boehringer Ingelheim Investigational Site
      • Glasgow, United Kingdom
        • 1200.74.44003 Boehringer Ingelheim Investigational Site
      • London, United Kingdom
        • 1200.74.44009 Boehringer Ingelheim Investigational Site
      • Manchester, United Kingdom
        • 1200.74.44012 Boehringer Ingelheim Investigational Site
      • Northwood, United Kingdom
        • 1200.74.44007 Boehringer Ingelheim Investigational Site
      • Nottingham, United Kingdom
        • 1200.74.44013 Boehringer Ingelheim Investigational Site
      • Poole, United Kingdom
        • 1200.74.44011 Boehringer Ingelheim Investigational Site
      • Sheffield, United Kingdom
        • 1200.74.44010 Boehringer Ingelheim Investigational Site
      • Southampton, United Kingdom
        • 1200.74.44008 Boehringer Ingelheim Investigational Site
      • Sutton, Surrey, United Kingdom
        • 1200.74.44004 Boehringer Ingelheim Investigational Site
      • Truro, United Kingdom
        • 1200.74.44002 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BIBW 2992
Patients receive BIBW 2992 tablets once daily
Drug: BIBW 2992
Patients receive BIBW 2992 tablets once daily, and can reduce dose for adverse event management
Active Comparator: Cetuximab
Patients receive cetuximab intravenously once a week, every week
Drug: Cetuximab
Patients receive cetuximab intravenously, once a week, every week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Objective Response
Time Frame: 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.
Baseline till progression or death, whichever came first, assessed up to 23 months
Percentage of Participants With Disease Control (DC)
Time Frame: 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.
Baseline till progression or death, whichever came first, assessed up to 23 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: 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.
Baseline till progression or death, whichever came first, assessed up to 23 months
Overall Survival (OS) Time
Time Frame: 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.
Baseline till death, assessed up to 23 months
Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 8 (Cpre,ss,8)
Time Frame: day 8
Cpre,ss,8 represents the pre-dose concentration of afatinib in plasma at steady state on day 8.
day 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

June 28, 2010

First Submitted That Met QC Criteria

June 28, 2010

First Posted (Estimate)

June 29, 2010

Study Record Updates

Last Update Posted (Estimate)

June 26, 2014

Last Update Submitted That Met QC Criteria

May 27, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1200.74
  • 2009-011996-59 (EudraCT Number: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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