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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: January 2, 2012
Last verified: January 2012
History of Changes
  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: Allocation: Non-Randomized
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:

U.S. FDA Resources

Further study details as provided by Genmab:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Until death ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: Until death ] [ Designated as safety issue: Yes ]
  • Time to progression [ Time Frame: Until time to progression ] [ Designated as safety issue: No ]

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
1
Single-arm
 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
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

Responsible Party: Genmab
ClinicalTrials.gov Identifier: NCT00542308     History of Changes
Other Study ID Numbers: GEN205
Study First Received: October 10, 2007
Last Updated: January 2, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Carcinoma
 Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on May 21, 2013