Prospective, 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 in Korea

August 28, 2014 updated by: Merck KGaA, Darmstadt, Germany

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)

After consultation with the Korean Health Authorities, the two Post-Authorization Safety Studies EMR 62202-509 (NCT01082315) and EMR 62241-508 (NCT01075828) were combined within one study protocol EMR 062202-551. This Post-Marketing Surveillance Study (PMS) EMR 062202-551 is requested by the Korean Health Authorities to continue monitoring of Erbitux and provide further information about safety and toxicity in clinical practice in at least 900 patients during 6 years.

All data points from the EMR 62202-509 (NCT01082315) and EMR 62241-508 (NCT01075828) remain unchanged in protocol EMR 062202-551. Therefore, the Sponsor has decided not to separately disclose the EMR 062202-551 study titled "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 (originally EMR 62241-508) and in Patients With EGFR-expressing, KRAS wild-type Metastatic Colorectal Cancer (originally EMR 62202-509)" on clinicaltrials.gov.

Study Overview

Status

Completed

Conditions

Head and Neck Cancer

Intervention / Treatment

Drug: Cetuximab

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

221

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Korea, Republic of
- - Jung-gu Daejeon, Korea, Republic of, 301-721
    - Chungnam National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with locally advanced or recurrent and/or metastatic SCCHN eligible for Erbitux treatment will be enrolled in the study.

Description

Inclusion Criteria:

Subjects who are eligible for Erbitux treatment according to the indication in the national label of Erbitux. The national label approved by Korea Food & Drug Administration is "Erbitux in combination with radiation therapy is indicated for the treatment of subjects with locally advanced or recurrent and/or metastatic SCCHN

Exclusion Criteria:

Subjects who are not eligible for Erbitux treatment according to the indication in the national label of Erbitux

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Adverse Events Time Frame: 6 years	The frequency and severity of all adverse events, regardless of the causal relationship to Erbitux, will be measured within 6 years of the observational period from the approval date of the new indication	6 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical efficacy Time Frame: 6 years	The duration of control of locoregional disease, 1-year/2-year/3-year locoregional control rate, best tumor response will be measured within the observational period from the approval date of the new indication	6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck KGaA, Darmstadt, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

February 24, 2010

First Submitted That Met QC Criteria