Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003456

Trial Description

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Title

An Open-label, Single Arm, Phase II Trial to Investigate the Safety and Efficacy of Sym004 in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) Who Have Failed Anti-EGFR Monoclonal Antibody-based Therapy

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The trial is designed as a multi-centre, open label phase II trial that investigates the
efficacy and safety of Sym004 in patients with squamous cell cancer of the head and neck
(SCCHN).

Patients included must have responded to previous anti-EGFR monoclonal antibody-based
therapy and subsequently become resistant to that therapy.

It is believed that Sym004 has the potential to induce tumor responses and provide a
superior treatment option to patients with advanced SCCHN.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00003456
  •   2012/11/15
  •   2011/07/15
  •   no
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Secondary IDs

  •   NCT01417936  (ClinicalTrials.gov)
  •   Sym004-02  (Symphogen A/S)
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Health Condition or Problem studied

  •   Carcinoma, Squamous Cell of Head and Neck
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Interventions/Observational Groups

  •   Biological: Sym004
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Characteristics

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

- Rate of Progression Free Survival (PFS); time frame: 24 weeks

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Secondary Outcome

- Adverse Events
- Objective Tumor Response
- Biomarkers; Tumor and skin biopsies are assessed for inhibition of EGFR and downstream intermediates.
Optional biomarker study will investigate associations between biological parameters and clinical features such as disease symptoms, drug response or potential adverse events.

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Countries of Recruitment

  •   United States
  •   Belgium
  •   France
  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2011/07/31
  •   25
  •   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

- Histologically confirmed diagnosis initially or at relapse of SCCHN of the oral
cavity, oropharynx, hypopharynx or larynx

- Recurrent and/or metastatic SCCHN not amenable to curative treatment with surgery
and/or (chemo)radiation

- Previous treatment with an anti-EGFR mAb in the palliative setting either as
monotherapy or in combination with chemotherapy or radiotherapy and showing:

- Documented clinical benefit or response for at least 8 weeks (PR, CR or SD) on
the anti-EGFR mAb-based therapy and

- Documented disease progression (verified by CT scan or MRI according to RECIST
(1.1) during or within 12 weeks following the last administration of anti-EGFR
mAb

- Accessible tumor for biopsy and patient acceptance of repeat tumor biopsies

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Exclusion Criteria

- More than 2 lines of prior chemotherapy in the palliative setting

- Expected survival <12 weeks

- Patients with known brain metastases

- Chemotherapy or radiation therapy within 21 days prior to Visit 2 at the exception of
palliative radiotherapy for bleeding or pain, which is allowed anytime, if not given
on target lesions

- Anti-EGFR mAbs within 14 days prior to Visit 2

- Major surgery within 4 weeks prior to Visit 2 and patients must have recovered from
effects of major surgery

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Addresses

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    • Symphogen A/S
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up complete
  •   2012/10/01
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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 .
  •   13
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.