Status:
COMPLETED
Zalutumumab in Head and Neck Cancer
Lead Sponsor:
Genmab
Conditions:
Head and Neck Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this trial is to determine the safety of zalutumumab as a treatment for head and neck cancer.
Eligibility Criteria
Inclusion
- Histologically confirmed 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
- 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.
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 12 2005
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00093041
Start Date
December 1 2003
End Date
January 12 2005
Last Update
June 28 2023
Active Locations (5)
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1
Århus Kommunehospital
Århus C, Denmark, 8000
2
Rigshospitalet
Copenhagen Ø, Denmark, 2100
3
Odense Universitetshospital
Odense, Denmark, 5000
4
Universitets Sjukhuset i Lund
Lund, Sweden, 221 85