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.