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Zalutumumab in Non-curable Patients With SCCHN

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ClinicalTrials.gov Identifier: NCT00542308
Recruitment Status : Completed
First Posted : October 11, 2007
Results First Posted : August 27, 2014
Last Update Posted : August 27, 2014
Sponsor:
Information provided by (Responsible Party):
Genmab

Brief Summary:
Treatment, In combination with BSC, Open-label, Single arm, Efficacy Study.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Squamous Cell Cancer Drug: Zalutumumab Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
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.
Study Start Date : January 2008
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. 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



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

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

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
Genmab
Investigators
Study Director: Steen Lisby, MD Genmab A/S, Bredgade 34, DK-1260 Copenhagen K, Denmark

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 Posted: October 11, 2007    Key Record Dates
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
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs