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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

NCT01075828 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 221

Last updated 2014-08-29

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Cetuximab

Subjects will be treated according to the national label of cetuximab in combination with radiation therapy.

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • South Korea

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Drugs
Diseases

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 NCT01075828 on ClinicalTrials.gov