A Post-Marketing Surveillance Study On Erbitux® (Cetuximab) In Patients With Metastatic Colorectal Cancer Refractory To Irinotecan Containing Treatment

Merck KGaA (EMD Serono)

Status: Completed

Conditions: Metastatic Colorectal Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT01134640

ESST

Details and patient eligibility

About

A post marketing surveillance, prospective study to collect safety information from 250 subjects with epidermal growth factor receptor (EGFR) expressing, KRAS wild-type metastatic colorectal cancer treated with Erbitux as final evaluable cases.

Enrollment: 286 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• EGFR expressing, KRAS wild-type subjects with metastatic colorectal cancer, who are indicated for Erbitux treatment according to the nationally authorized label (in combination with irinotecan, metastatic colorectal cancer after failure of irinotecan-including cytotoxic therapy)

Exclusion criteria

• Subjects who are not eligible for Erbitux treatment according to the indication in national label; or with hypersensitivity reactions (grade 3 or 4) to Erbitux