Status:

COMPLETED

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

Lead Sponsor:

Boehringer Ingelheim

Conditions:

Colorectal Neoplasms

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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-EG...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    June 1 2010

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    94 Patients enrolled

    Trial Details

    Trial ID

    NCT01152437

    Start Date

    June 1 2010

    Last Update

    June 26 2014

    Active Locations (13)

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    Page 1 of 4 (13 locations)

    1

    1200.74.44001 Boehringer Ingelheim Investigational Site

    Bournemouth, United Kingdom

    2

    1200.74.44005 Boehringer Ingelheim Investigational Site

    Bristol, United Kingdom

    3

    1200.74.44006 Boehringer Ingelheim Investigational Site

    Cambridge, United Kingdom

    4

    1200.74.44003 Boehringer Ingelheim Investigational Site

    Glasgow, United Kingdom

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