Inclusion Criteria:

- Males and females ≥ 18 years.

- Diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or
larynx, considered incurable with standard therapy. Diagnosis will have been
confirmed using a biopsy of the tumour.

- Patients having, based on the investigators judgment, had disease progression and for
whom curative therapy is not possible.

- Patients with a WHO performance status ≤ 2 and a life expectancy of greater than 3
months.

- Following receipt of verbal and written information about the study, the patient must
provide signed informed consent before any study related activity is carried out.

Exclusion Criteria:

- Patients previously treated with any Epidermal Growth Factor Receptor (EGFR) targeted
therapy such as anti-EGFR monoclonal antibodies or small molecule inhibitors within 6
months prior to visit 2 (first treatment).

- Received the following treatments within 4 weeks prior to Visit 2 (first treatment):

- Cytotoxic or cytostatic anticancer chemotherapy

- Total tumor resection

- Radiotherapy of > 50 Gy to gross tumor volume

- Chronic or current infectious disease such as, but not limited to, chronic renal
infection, chronic chest infection with bronchiectasis, sinusitis, and tuberculosis

- Clinically significant cardiac disease including unstable angina, acute myocardial
infarction within six months from Visit 1 (screening), congestive heart failure, and
arrhythmia requiring therapy, with the exception of extra systoles or minor
conduction abnormalities

- Significant concurrent, uncontrolled medical condition including, but not limited to,
renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, neurological,
cerebral or psychiatric disease

- History of significant cerebrovascular disease

- Known HIV infection

- Known hepatitis B and/or hepatitis C

- Screening laboratory values:

- Neutrophils < 1.5 x109/l

- Platelets < 75 x109/l

- ALAT > 2.5 times the upper limit of normal (unless known liver metastases
exceptions will be dealt with on a case by case basis)

- ALP > 2.5 times the upper limit of normal (unless known liver metastases
exceptions will be dealt with on a case by case basis)

- Bilirubin > 1.5 times the upper limit of normal

- Creatinine clearance < 50 ml/min (measured or calculated by the CockgroftGault
method)

- Patients who have received treatment with any non-marketed drug substance within 4
weeks before Visit 1(screening)

- Current participation in any other interventional clinical study

- Patients with a BMI ≥ 30 kg/m2

- Patients known or suspected of not being able to comply with a study protocol (e.g.
due to alcoholism, drug dependency or psychological disorder)

- Breast feeding women or women with a positive pregnancy test at Visit 1 (screening)

- Women of childbearing potential not willing to use adequate contraception such as
hormonal birth control or intrauterine device during study.