Zalutumumab in Head and Neck Cancer

Genmab

Status and phase: Completed; Phase 2; Phase 1

Conditions: Head and Neck Neoplasms

Treatments: Drug: Zalutumumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00093041

Hx-EGFr-001

Details and patient eligibility

About

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

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 6 patient groups

Zalutumumab 0.15 mg/kg

Experimental group

Treatment:

Drug: Zalutumumab

Zalutumumab 0.5 mg/kg

Experimental group

Treatment:

Drug: Zalutumumab

Zalutumumab 1 mg/kg

Experimental group

Treatment:

Drug: Zalutumumab

Zalutumumab 2 mg/kg

Experimental group

Treatment:

Drug: Zalutumumab

Zalutumumab 4 mg/kg

Experimental group

Treatment:

Drug: Zalutumumab

Zalutumumab 8 mg/kg

Experimental group

Treatment:

Drug: Zalutumumab