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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.


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer, Squamous Cell Cancer

Thank you

Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Overall survival

Outcome Time Frame:

Until death

Safety Issue:

No

Principal Investigator

Steen Lisby, MD

Investigator Role:

Study Director

Investigator Affiliation:

Genmab A/S, Bredgade 34, DK-1260 Copenhagen K, Denmark

Authority:

United States: Food and Drug Administration

Study ID:

GEN205

NCT ID:

NCT00542308

Start Date:

January 2008

Completion Date:

August 2011

Related Keywords:

  • Head and Neck Cancer
  • Squamous Cell Cancer
  • Carcinoma, Squamous Cell
  • Neoplasms, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

Mountain States Tumor InstituteBoise, Idaho  83712
Baylor University Medical CenterDallas, Texas  75246
Loma Linda University Cancer InstituteLoma Linda, California  92354
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
Henry Ford Health SystemsDetroit, Michigan  48202
University of Chicago Medical CenterChicago, Illinois  60637
Moffitt Cancer CenterTampa, Florida  33612
Oregon Health and Science UniversityPortland, Oregon  97201
Ft. Wayne Medical Oncology/Hematology, IncFt. Wayne, Indiana  46815