Phase 2 Completed N=28 Treatment

Zalutumumab in Head and Neck Cancer

Head and Neck Cancer

Source: ClinicalTrials.gov NCT00093041 ↗

Enrolled (actual)

Serious AEs

53.6%

Results posted

Dec 2011

Primary outcomePrimary: Adverse Events — 4; 4; 5; 4 participants

Summary

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Adverse Events	4; 4; 5; 4; 4; 7	—
SECONDARY Overall Response (OR), Classification	0; 0; 0; 0; 0; 0	—

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00093041). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.