Phase I/II clinical and pharmacokinetic study evaluating a fully human monoclonal antibody against EGFr (HuMax-EGFr) in patients with advanced squamous cell carcinoma of the head and neck
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| Title: | Phase I/II clinical and pharmacokinetic study evaluating a fully human monoclonal antibody against EGFr (HuMax-EGFr) in patients with advanced squamous cell carcinoma of the head and neck |
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| Authors: | Bastholt, Lars1 lars.bastholt@ouh.regionsyddanmark.dk, Specht, Lena2, Jensen, Kenneth3, Brun, Eva4, Loft, Annika5, Petersen, Jørgen6, Kastberg, Helle6, Eriksen, Jesper G.1 |
| Source: | Radiotherapy & Oncology. Oct2007, Vol. 85 Issue 1, p24-28. 5p. |
| Subjects: | Pharmacokinetics, Patients, Tumors, Medical care |
| Abstract: | Abstract: Purpose: To assess safety, tolerability, pharmacokinetics and clinical activity of HuMax-EGFr in patients with SCCHN. Patients and methods: Twenty-eight patients with SCCHN were enrolled. The study comprised a single-dose escalation part for assessment of safety issues followed by a repeat dose extension including 4 weekly infusions at the same doses. Efficacy and metabolic response were evaluated according to RECIST by CT and FDG-PET. Results: Most frequently reported adverse event was rash. All but one event were CTC grade 1 or 2 and a dose-dependent relationship was indicated. Duration of skin reactions varied from few days to 2months. No DLTs were observed and MTD was not reached. In the two highest dose groups, 7 of 11 patients obtained a PR or SD and 9 patients obtained metabolic PR or SD. Conclusions: HuMax-EGFr can be safely administered in doses up to 8mg/kg, and preliminary data on tumour response are encouraging. [Copyright &y& Elsevier] |
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| Database: | Engineering Source |
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