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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

Bastholt, Lars; Specht, Lena; Jensen, Kenneth; Brun, Eva LU ; Loft, Annika; Petersen, Jorgen; Kastberg, Helle and Eriksen, Jesper G. (2007) In Radiotherapy and Oncology 85(1). p.24-28
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 2 months. No DLTs were observed and MTD was not reached. In the two highest dose groups, 7 of 11 patients... (More)
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 safety administered in doses up to 8 mg/kg, and preliminary data on tumour response are encouraging. (c) 2007 Elsevier Ireland Ltd. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
pharmacodynamics, phase I/II, pharmacokinetics, human monoclonal antibody, epidermal growth factor receptor
in
Radiotherapy and Oncology
volume
85
issue
1
pages
24 - 28
publisher
Elsevier
external identifiers
  • wos:000251222000004
  • scopus:35248870658
ISSN
1879-0887
DOI
10.1016/j.radonc.2007.06.007
language
English
LU publication?
yes
id
0b14898e-f839-42f4-882a-759c1220a98b (old id 968774)
date added to LUP
2008-01-29 13:01:57
date last changed
2017-02-19 03:29:41
@article{0b14898e-f839-42f4-882a-759c1220a98b,
  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 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 safety administered in doses up to 8 mg/kg, and preliminary data on tumour response are encouraging. (c) 2007 Elsevier Ireland Ltd.},
  author       = {Bastholt, Lars and Specht, Lena and Jensen, Kenneth and Brun, Eva and Loft, Annika and Petersen, Jorgen and Kastberg, Helle and Eriksen, Jesper G.},
  issn         = {1879-0887},
  keyword      = {pharmacodynamics,phase I/II,pharmacokinetics,human monoclonal antibody,epidermal growth factor receptor},
  language     = {eng},
  number       = {1},
  pages        = {24--28},
  publisher    = {Elsevier},
  series       = {Radiotherapy and Oncology},
  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},
  url          = {http://dx.doi.org/10.1016/j.radonc.2007.06.007},
  volume       = {85},
  year         = {2007},
}