Trial Information

A Korean Post Marketing Surveillance Study On Erbitux® (Cetuximab) In Patients With Locally Advanced or Recurrent and/or Metastatic Squamous Cell Cancer of the Head and Neck (SCCHN)

This is a prospective, Post Marketing Surveillance (PMS) study on Erbitux® (Cetuximab) in
patients with locally advanced or recurrent and/or metastatic squamous cell cancer of the
head and neck in Korea

This prospective study will collect safety information from more than 300 subjects treated
with Erbitux as final evaluable cases. During the PMS period, subject background, subject's
medical (surgery, anti-cancer treatment) history, Erbitux treatment status, concurrent
medication, response evaluation, status and reason of discontinuation, all adverse events
(AEs; regardless of the causal relationship to Erbitux), and abnormal results of laboratory
tests will be collected for the study purpose.

The PMS is based on all cases treated with Erbitux at least once. The PMS will be done
within 6 years from the approval date of the new indication. This PMS is requested by the
Korean Regulatory Authorities. After approval of new indication in Korea, it is further
required to investigate more than 300 subjects during 6 years according to local regulations
to continue monitoring and provide further information about safety and toxicity in clinical
practice.

OBJECTIVES Analysis on safety and efficacy information on the use of Erbitux in the market
and factors affecting its safety and efficacy.

Primary objective:

- To obtain safety information on the use of Erbitux in subjects with locally advanced
SCCHN or recurrent and/or metastatic in terms of frequency and severity of AEs

Secondary objectives:

- To gather clinical efficacy information of the treatment