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A Post-marketing Surveillance Study on Erbitux in Combination With Platinum-based Chemotherapy in Metastatic/Recurrent Squamous Cell Cancer of the Head and Neck

NCT01075841 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2014-07-02

No results posted yet for this study

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.

Conditions

  • Neoplasms, Squamous Cell

Interventions

DRUG

Cetuximab

Subjects who are eligible for Erbitux treatment according to the indication in the national label of Erbitux (i.e. where Erbitux is used in combination with platinum-based therapy for the treatment of subjects with recurrent and/or metastatic SCCHN) 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.

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2009-03-31

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Drugs

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 NCT01075841 on ClinicalTrials.gov