An Observational Study of Erbitux® in Patients With Metastatic Colorectal Cancer (mCRC) Refractory to Irinotecan-containing Treatment

• Status: Terminated
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an observational, non-interventional, uncontrolled, multicentric safety study in subjects with epidermal growth factor receptor (EGFR)-expressing, V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) wild-type mCRC. The study aims to collect safety data related to Erbitux treatment from a total of at least 400 mCRC subjects from about 35 institutions from the start of treatment with Erbitux until progressive disease, Erbitux-related intolerable toxicities, death, or withdrawal of Erbitux treatment (whichever occurs first).

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Collaborator: Merck Ltd.
• Treatments: Cetuximab

Criteria

Inclusion Criteria:

• Subjects who are eligible for Erbitux treatment according to the indication in the national label of Erbitux (i.e. in EGFR expressing, KRAS wild-type metastatic colorectal adenocarcinoma).

• Subjects who have failed oxaliplatin and irinotecan-based therapy and who are intolerant to irinotecan in mCRC.

• Subjects who have signed the informed consent form

Exclusion Criteria:

• Subjects who do not fall under the approved indications according to the national label of Erbitux.