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Zalutumumab in Non-curable Patients With SCCHN

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genmab
ClinicalTrials.gov Identifier:
NCT00542308
First received: October 10, 2007
Last updated: August 12, 2014
Last verified: January 2012
  Purpose

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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Genmab

Additional 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
Study First Received: October 10, 2007
Results First Received: August 12, 2014
Last Updated: August 12, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 25, 2014