Kenneth Jensen

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

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avisTidsskriftartikelForskningpeer review

  • Lars Bastholt, Danmark
  • Lena Specht, Danmark
  • Kenneth Jensen
  • Eva Brun, Danmark
  • Annika Loft, Danmark
  • Jørgen Petersen, Danmark
  • Helle Kastberg, Danmark
  • Jesper G Eriksen
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 2 months. 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 8 mg/kg, and preliminary data on tumour response are encouraging.
Udgivelsesdato: 2007-Oct
TidsskriftRadiotherapy & Oncology
Sider (fra-til)24-8
Antal sider4
StatusUdgivet - 2007

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