A Prospective, Post Marketing Surveillance Study On Erbitux® (Cetuximab) in Patients With Locally Advanced Squamous Cell Cancer of the Head and Neck in Korea

2014-08-27 03:15:37 | BioPortfolio


This is a prospective, post-marketing surveillance (PMS) study on Erbitux (Cetuximab) in subjects with locally advanced squamous cell cancer of the head and neck (SCCHN) in Korea.


This prospective study will collect safety information from more than 600 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 will be based on all cases treated with Erbitux at least once. This PMS is to be done within 6 years from the approval date of the new indication which has been requested by the Korean Regulatory Authorities. After approval of new indication in Korea, it is further required to investigate more than 600 subjects during 6 years according to local regulations to continue monitoring and provide further information about safety and toxicity in clinical practice.


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 in terms of frequency and severity of AEs

Secondary objectives:

- To gather clinical efficacy information of the treatment

All subjects will be enrolled in the order to visit the physician after making a contract in about 50 different institutions in Korea.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Head and Neck Cancer




Chungnam National University Hospital
Jung-gu Daejeon
Korea, Republic of




Merck KGaA

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:15:37-0400

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