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

NCT01080066 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 215

Last updated 2014-07-08

No results posted yet for this study

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.

Conditions

  • Carcinoma, Squamous Cell of Head and Neck

Interventions

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).

Sponsors & Collaborators

  • Choice Pharma Taiwan

    collaborator UNKNOWN

  • Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Chao-Jung Tsao, Dr. · Liouying Chi-Mei Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01080066 on ClinicalTrials.gov