NCT01080066

A Post Marketing Surveillance Study of Cetuximab in Patients With Squamous Cell Carcinoma of Head and Neck (SCCHN)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 215 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, observational, non-interventional, multicenter, post-marketing surveillance study to mainly collect safety information from subjects with locally advanced and recurrent/metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN) treated with cetuximab based on the locally approved label.

Detailed description

Cetuximab is an immunoglobulin G1 (IgG1) monoclonal antibody that enhances the effects of some common chemotherapy agents and radiotherapy and demonstrates minimal overlapping toxicities with these approaches. This prospective, observational, non-interventional and multi-centric post marketing surveillance study is being conducted to collect safety information from subjects with locally advanced or recurrent/metastatic SCCHN treated with cetuximab based on the locally approved label. Study plans to enroll 200 to 300 subjects, who are eligible for cetuximab treatment according to the indication in the approved label of cetuximab by Taiwan Health Authority. Data related to subjects' demographics, relevant tumor history, and laboratory information (hematology, biochemistry) will be captured and analyzed descriptively. OBJECTIVES Primary objective: • To obtain safety information on the use of cetuximab in subjects with SCCHN according to the regulatory approved label and in a regular clinical setting Secondary objectives: • To gather clinical efficacy information of the treatment

Conditions

• Carcinoma, Squamous Cell of Head and Neck

Interventions

Type	Name	Description
OTHER	No Intervention	Subjects administered with Cetuximab, once weekly by intravenous infusion at a first dose of 400 milligram per square meter (mg/m\^2) body surface area for 120 minutes infusion period and subsequently at a dose of 250 mg/m\^2 for 60 minutes infusion period, will be observed. The maximum infusion rate must not exceed 10 milligram per minute (mg/min).

Timeline

• Start date: 2010-09-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2010-03-03
• Last updated: 2014-07-08

Locations

1 site across 1 country: Taiwan