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

Genmab A/S0 sites26 target enrollmentNovember 2, 2009

Overview

No summary available.

Registry

who.int

Start Date

November 2, 2009

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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

•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