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Zalutumumab in Non-curable Patients With SCCHN

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: October 11, 2007
Last Update Posted: August 27, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Treatment, In combination with BSC, Open-label, Single arm, Efficacy Study.

Condition Intervention Phase
Head and Neck Cancer Squamous Cell Cancer Drug: Zalutumumab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: An Open Label Single Arm Trial Investigating Zalutumumab, a Human Monoclonal Anti-EGF Receptor Antibody, in Combination With Best Supportive Care, in Patients With Non-Curable Squamous Cell Carcinoma of the Head and Neck Who Have Failed Standard Platinum-based Chemotherapy.

Resource links provided by NLM:

Further study details as provided by Genmab:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: From randomization until death, assessed up to 21 months ]
    Overall survival was defined as time from start of treatment until date of death of any cause.

Secondary Outcome Measures:
  • Tumour Response [ Time Frame: During treatment and two weeks after end of treatment, assessed up to 21 months. ]
    Tumour response according to Response Evaluation Criteria in Solid Tumours (RECIST v 1.0)J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR

Enrollment: 90
Study Start Date: January 2008
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zalutumumab 4-16 mg/kg
Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.
Drug: Zalutumumab
Individual dose titration weekly i.v. doses


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Males and females age ≥ 18 years
  2. Confirmed diagnosis, initially or at relapse, of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, considered incurable with standard therapy
  3. Failure to at least one course of standard platinum-based chemotherapy

Exclusion Criteria:

  1. Three or more prior chemotherapy regimens
  2. Prior treatment with EGFr antibodies and/or EGFr small molecule inhibitors
  3. Past or current malignancy other than SCCHN, except for certain other cancer diseases
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00542308

  Show 48 Study Locations
Sponsors and Collaborators
Study Director: Steen Lisby, MD Genmab A/S, Bredgade 34, DK-1260 Copenhagen K, Denmark
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Genmab
ClinicalTrials.gov Identifier: NCT00542308     History of Changes
Other Study ID Numbers: GEN205
First Submitted: October 10, 2007
First Posted: October 11, 2007
Results First Submitted: August 12, 2014
Results First Posted: August 27, 2014
Last Update Posted: August 27, 2014
Last Verified: January 2012

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs