An Open-label, Multi-Center, Phase I/II Trial Investigating the Pharmacokinetic profile of Zalutumumab, a Human Monoclonal Epidermal Growth Factor Receptor Antibody in non-curable patients with SCCHN - Zalutumumab PK in SCCH

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 26

Inclusion Criteria

1.Males and females = 18 years.
2.Histologically or cytologically confirmed diagnosis squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, considered incurable with standard therapy.
3.Patient having based on the investigators judgment had disease progression and who are eligible for palliative treatment only.
4.Expected survival > 3 months. The patients must have performance status = 2 according to WHO
5.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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Patients previously treated with any EGFR targeted therapy such as anti-EGFR monoclonal antibodies or small molecule inhibitors within 6 months prior to visit 2.
2.Received the following treatments within 4 weeks prior to Visit 2:
•Cytotoxic or cytostatic anti-cancer chemotherapy
•Total tumor resection
•Radiotherapy of > 50 Gy to gross tumor volume
3.Chronic or current infectious disease such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, sinusitis, and tuberculosis
4.Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months from Visit 1, congestive heart failure, and arrhythmia requiring therapy, with the exception of extra systoles or minor conduction abnormalities
5.Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease
6.History of significant cerebrovascular disease
7.Known HIV infection
8.Known hepatitis B and/or hepatitis C
9.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)
•ALP > 2.5 times the upper limit of normal (unless known bone metastases)
•Bilirubin > 1.5 times the upper limit of normal
•Creatinine clearance < 50 ml/min (measured or calculated by the Cockgroft-Gault method)
10.Patients who have received treatment with any non-marketed drug substance within 4 weeks prior to Visit 1 (screening)
11.Current participation in any other interventional clinical study
12.Patients with a BMI = 30 kg/m2
13.Patients known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency or psychological disorder)
14.Breast feeding women or women with a positive pregnancy test at Visit 1
15.Women of childbearing potential not willing to use adequate contraception as hormonal birth control or intrauterine device during study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine key pharmacokinetic parameters for zalutumumab as monotherapy in patients with SCCHN.;Secondary Objective: To investigate the safety and secondary pharmacokinetic parameters of weekly administrations of i.v zalutumumab as monotherapy in patients with SCCHN.;Primary end point(s): Primary pharmacokinetic endpoints: <br>The exposure (AUC) and peak concentration (Cmax) after single dose (1st infusion) and after multiple doses (4th infusion) of zalutumumab.<br>

Secondary Outcome Measures

Name	Time	Method

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