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Sym004 in SCCHN Patients Failing Anti-EGFR Based Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01417936
First received: July 15, 2011
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Carcinoma, Squamous Cell of Head and Neck
Biological: Sym004
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Rate of Progression Free Survival (PFS) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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.



Enrollment: 26
Study Start Date: July 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sym004
Weekly administration of Sym004
Biological: Sym004
Other Name: Sym004

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01417936

Locations
Belgium
3203; Antwerp University Hospital; Department of Medical Oncology
Antwerp, Edegem, Belgium, 2650
3201; Cliniques Universitaires St-Luc; Centre du Cancer
Bruxelles, Belgium, 1200
3202; Jules Bordet Institute; Clinique d'Oncologie Médicale
Bruxelles, Belgium, 1000
France
3303; Centre Alexis Vautrin; Département d'Oncologie Médicale
Nancy, Vandoeuvre Les Nancy, France, 54111
Germany
4905; Charité Campus Benjamin Franklin; Hematology, Oncology and Transfusion Medicine
Berlin, Germany, 12200
4901; Universitätsklinikum Essen
Essen, Germany, 45122
4904; Universitätsklinikum Freiburg
Freiburg, Germany, 79106
4906; University Medical Center Hamburg Eppendorf; Department of Otorhinolaryngology and Head and Neck Surgery
Hamburg, Germany, 20246
4907; University Hospital Heidelberg; Nationales Centrum für Tumorerkrankungen (NCT)
Heidelberg, Germany, 6912
4902; University of Leipzig
Leipzig, Germany, 04103
Sponsors and Collaborators
Merck KGaA
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01417936     History of Changes
Other Study ID Numbers: Sym004-02
Study First Received: July 15, 2011
Last Updated: May 28, 2014
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicines and Health Products, FAMHP
France: Agence française de sécurité sanitaire des produits de santé (Afssaps)
Germany: Paul-Erhlich-Institut, Federal Institute for Vaccines and Biomedicines

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell

ClinicalTrials.gov processed this record on November 25, 2014