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

Boehringer Ingelheim

Status and phase

Completed

Phase 2

Conditions

Colorectal Neoplasms

Treatments

Drug: Cetuximab

Drug: BIBW 2992

Study type

Interventional

Funder types

Industry

Identifiers

NCT01152437

1200.74

2009-011996-59 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

94 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.