View in EDS

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

Saved in:
Bibliographic Details
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
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]
Copyright of Radiotherapy & Oncology is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Engineering Source
FullText Text:
  Availability: 0
Header DbId: egs
DbLabel: Engineering Source
An: 27152104
AccessLevel: 6
PubType: Academic Journal
PubTypeId: academicJournal
PreciseRelevancyScore: 0
IllustrationInfo
Items – Name: Title
  Label: Title
  Group: Ti
  Data: 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
– Name: Author
  Label: Authors
  Group: Au
  Data: <searchLink fieldCode="AR" term="%22Bastholt%2C+Lars%22">Bastholt, Lars</searchLink><relatesTo>1</relatesTo><i> lars.bastholt@ouh.regionsyddanmark.dk</i><br /><searchLink fieldCode="AR" term="%22Specht%2C+Lena%22">Specht, Lena</searchLink><relatesTo>2</relatesTo><br /><searchLink fieldCode="AR" term="%22Jensen%2C+Kenneth%22">Jensen, Kenneth</searchLink><relatesTo>3</relatesTo><br /><searchLink fieldCode="AR" term="%22Brun%2C+Eva%22">Brun, Eva</searchLink><relatesTo>4</relatesTo><br /><searchLink fieldCode="AR" term="%22Loft%2C+Annika%22">Loft, Annika</searchLink><relatesTo>5</relatesTo><br /><searchLink fieldCode="AR" term="%22Petersen%2C+Jørgen%22">Petersen, Jørgen</searchLink><relatesTo>6</relatesTo><br /><searchLink fieldCode="AR" term="%22Kastberg%2C+Helle%22">Kastberg, Helle</searchLink><relatesTo>6</relatesTo><br /><searchLink fieldCode="AR" term="%22Eriksen%2C+Jesper+G%2E%22">Eriksen, Jesper G.</searchLink><relatesTo>1</relatesTo>
– Name: TitleSource
  Label: Source
  Group: Src
  Data: <searchLink fieldCode="JN" term="%22Radiotherapy+%26+Oncology%22">Radiotherapy & Oncology</searchLink>. Oct2007, Vol. 85 Issue 1, p24-28. 5p.
– Name: Subject
  Label: Subjects
  Group: Su
  Data: <searchLink fieldCode="DE" term="%22Pharmacokinetics%22">Pharmacokinetics</searchLink><br /><searchLink fieldCode="DE" term="%22Patients%22">Patients</searchLink><br /><searchLink fieldCode="DE" term="%22Tumors%22">Tumors</searchLink><br /><searchLink fieldCode="DE" term="%22Medical+care%22">Medical care</searchLink>
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: 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]
– Name: AbstractSuppliedCopyright
  Label:
  Group: Ab
  Data: <i>Copyright of Radiotherapy & Oncology is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
PLink https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=egs&AN=27152104
RecordInfo BibRecord:
  BibEntity:
    Identifiers:
      – Type: doi
        Value: 10.1016/j.radonc.2007.06.007
    Languages:
      – Code: eng
        Text: English
    PhysicalDescription:
      Pagination:
        PageCount: 5
        StartPage: 24
    Subjects:
      – SubjectFull: Pharmacokinetics
        Type: general
      – SubjectFull: Patients
        Type: general
      – SubjectFull: Tumors
        Type: general
      – SubjectFull: Medical care
        Type: general
    Titles:
      – TitleFull: 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
        Type: main
  BibRelationships:
    HasContributorRelationships:
      – PersonEntity:
          Name:
            NameFull: Bastholt, Lars
      – PersonEntity:
          Name:
            NameFull: Specht, Lena
      – PersonEntity:
          Name:
            NameFull: Jensen, Kenneth
      – PersonEntity:
          Name:
            NameFull: Brun, Eva
      – PersonEntity:
          Name:
            NameFull: Loft, Annika
      – PersonEntity:
          Name:
            NameFull: Petersen, Jørgen
      – PersonEntity:
          Name:
            NameFull: Kastberg, Helle
      – PersonEntity:
          Name:
            NameFull: Eriksen, Jesper G.
    IsPartOfRelationships:
      – BibEntity:
          Dates:
            – D: 01
              M: 10
              Text: Oct2007
              Type: published
              Y: 2007
          Identifiers:
            – Type: issn-print
              Value: 01678140
          Numbering:
            – Type: volume
              Value: 85
            – Type: issue
              Value: 1
          Titles:
            – TitleFull: Radiotherapy & Oncology
              Type: main
ResultId 1