Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003754

Trial Description

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Title

An Open Label Single Arm Trial Investigating Zalutumumab, a Human Monoclonal Anti-EGF Receptor Antibody, in Combination With Best Supportive Care, in Patients With Non-Curable Squamous Cell Carcinoma of the Head and Neck Who Have Failed Standard Platinum-based Chemotherapy.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Treatment, In combination with BSC, Open-label, Single arm, Efficacy Study.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00003754
  •   2012/06/20
  •   2007/10/10
  •   no
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Secondary IDs

  •   NCT00542308  (ClinicalTrials.gov)
  •   GEN205  (Genmab)
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Health Condition or Problem studied

  •   Head and Neck Cancer
  •   Squamous Cell Cancer
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Interventions/Observational Groups

  •   Drug: Zalutumumab
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
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  •   Single (group)
  •   II
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Primary Outcome

- Overall survival; time frame: Until death

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Secondary Outcome

- Safety; time frame: Until death
- Time to progression; time frame: Until time to progression

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Countries of Recruitment

  •   United States
  •   Austria
  •   Chile
  •   Colombia
  •   Czech Republic
  •   Germany
  •   Israel
  •   Italy
  •   Peru
  •   Portugal
  •   Slovakia
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Locations of Recruitment

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Recruitment

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  •   2008/01/31
  •   90
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

1. Males and females age ≥ 18 years

2. Confirmed diagnosis, initially or at relapse, of squamous cell carcinoma of the oral
cavity, oropharynx, hypopharynx or larynx, considered incurable with standard therapy

3. Failure to at least one course of standard platinum-based chemotherapy

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Exclusion Criteria

1. Three or more prior chemotherapy regimens

2. Prior treatment with EGFr antibodies and/or EGFr small molecule inhibitors

3. Past or current malignancy other than SCCHN, except for certain other cancer diseases

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Addresses

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    • Genmab
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    • Genmab A/S, Bredgade 34, DK-1260 Copenhagen K, Denmark
    • Steen Lisby, MD 
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    • Genmab A/S, Bredgade 34, DK-1260 Copenhagen K, Denmark
    • Steen Lisby, MD 
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Sources of Monetary or Material Support

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Status

  •   Recruiting complete, follow-up complete
  •   2011/08/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   10
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.