Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT01075841 |
| Other study ID # |
EMR 62241-510 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
February 24, 2010 |
| Last updated |
July 1, 2014 |
| Start date |
March 2009 |
Study information
| Verified date |
December 2010 |
| Source |
Merck KGaA |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Korea: Food and Drug Administration |
| Study type |
Observational
|
Clinical Trial Summary
This is a prospective post-marketing surveillance (PMS) study to collect safety information
from more than 600 subjects with recurrent and/or metastatic squamous cell cancer of the
head and neck (SCCHN) treated with Erbitux as final evaluable cases. This PMS study is
requested by the Korean Regulatory Authorities. After approval of new indication in Korea,
there is a requirement to investigate more than 600 subjects during six years, to continue
monitoring and provide further information about safety and toxicity in clinical practice.
Description:
The PMS study is planned to be conducted within 6 years from the approval date of the new
indication in approximately 50 institutions in Korea.
OBJECTIVES
Primary objective:
- To obtain safety information on the use of Erbitux in subjects with recurrent and/or
metastatic SCCHN in terms of frequency and severity of adverse events (AEs)
Secondary objectives:
- To gather clinical efficacy information of the treatment
During the PMS period, each subject's background, subject's medical history (surgery,
anti-cancer treatment), Erbitux treatment status, concurrent medication, response
evaluation, status and reason of discontinuation, all AEs (regardless of the causal
relationship to Erbitux), and abnormal results of laboratory tests will be collected. The
PMS will be based on all cases treated with Erbitux at least once.
Erbitux will be prescribed to recurrent and/or metastatic SCCHN subjects according to the
approved national label as in routine clinical practice under the supervision of an
investigator experienced in the use of antineoplastic medicinal products. Prior to the first
infusion, subjects will receive pre-medication with an antihistamine and a corticosteroid.
The initial dose of Erbitux is 400 mg/m2 body surface area and the subsequent weekly doses
are 250 mg/m2 each administered intravenously via in-line filtration with an infusion pump,
gravity drip, or a syringe pump. The recommended infusion period for the initial dose is 120
minutes and for the subsequent weekly doses is 60 minutes with the maximum infusion rate not
exceeding 10 mg/min, equivalent to 5 ml/min of Erbitux 2 mg/ml or 2ml/min of Erbitux 5mg/mL.
