Zalutumumab Pharmacokinetics (PK) in Squamous Cell Carcinoma of the Head and Neck (SCCHN)

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.