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

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.

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.