Zalutumumab in Head and Neck Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genmab
ClinicalTrials.gov Identifier:
NCT00093041
First received: September 30, 2004
Last updated: November 17, 2011
Last verified: November 2011

September 30, 2004
November 17, 2011
December 2003
January 2005   (final data collection date for primary outcome measure)
Adverse Events [ Time Frame: Overall Study ] [ Designated as safety issue: No ]
Number of participants reporting at least one adverse event
Not Provided
Complete list of historical versions of study NCT00093041 on ClinicalTrials.gov Archive Site
Overall Response, Classification [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Overall response was evaluated according to RECIST J Natl Cancer Inst 2000;92:205-16.
Not Provided
Not Provided
Not Provided
 
Zalutumumab in Head and Neck Cancer
An Open, Single Dose Escalation Study Followed by a Multiple Dose Extension of Anti-EGF Receptor Human Monoclonal Antibody (Zalutumumab) in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

The purpose of this trial is to determine the safety of zalutumumab as a treatment for head and neck cancer.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Head and Neck Neoplasms
Drug: Zalutumumab
Weekly infusion
  • Experimental: Zalutumumab 0.15 mg/kg
    Intervention: Drug: Zalutumumab
  • Experimental: Zalutumumab 0.5 mg/kg
    Intervention: Drug: Zalutumumab
  • Experimental: Zalutumumab 1 mg/kg
    Intervention: Drug: Zalutumumab
  • Experimental: Zalutumumab 2 mg/kg
    Intervention: Drug: Zalutumumab
  • Experimental: Zalutumumab 4 mg/kg
    Intervention: Drug: Zalutumumab
  • Experimental: Zalutumumab 8 mg/kg
    Intervention: Drug: Zalutumumab
Bastholt L, Specht L, Jensen K, Brun E, Loft A, Petersen J, Kastberg H, Eriksen JG. Phase I/II clinical and pharmacokinetic study evaluating a fully human monoclonal antibody against EGFr (HuMax-EGFr) in patients with advanced squamous cell carcinoma of the head and neck. Radiother Oncol. 2007 Oct;85(1):24-8. Epub 2007 Jun 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
January 2005
January 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

The study population eligible for this study is adult male or female patients of good performance status having a histologically confirmed recurrent or metastatic SCCHN, not amenable to standard curative or palliative therapies.

  • Diagnosis of squamous cell carcinoma of the oral cavity, nasal cavity, paranasal sinuses, nasopharynx, oropharynx, hypopharynx or larynx.
  • Primary or recurrent disease for which no curative or established palliative treatments are amenable
  • WHO performance status of 1 or 2.

Exclusion Criteria:

  • Received certain other treatments within 4 weeks prior to administration of study drug
  • Previous severe allergic reactions (e.g. angio-edema, severe asthma, or anaphylaxis).
  • Skin disease requiring systemic or local corticosteroid therapy.
  • Known brain metastasis or leptomeningeal disease.
  • Signs or symptoms of acute illness.
  • Bacterial, fungal or viral infection.
  • Certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, myocardial infarction within one year and stomach, lung, heart, hormonal, nerve or blood diseases.
  • Pregnant or breast-feeding women.
  • Women of childbearing age who are unable or unwilling to use an IUD or hormonal birth control during the whole trial.
  • Simultaneous participation in any other trial involving investigational drugs or having participated in a trial within 4 weeks prior to start of trial treatment.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Sweden
 
NCT00093041
Zalutumumab
Not Provided
Genmab
Genmab
Not Provided
Not Provided
Genmab
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP