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

This is an interventional treatment trial for Head and Neck Cancer focused on measuring Squamous Cell Carcinoma of the Head and Neck, Head and Neck Cancer, Head and Neck Neoplasms, anti-EGFr monoclonal antibody, Zalutumumab Read More

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.