Sym004 in SCCHN Patients Failing Anti-EGFR Based Therapy
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.
|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|
- Rate of Progression Free Survival (PFS) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Adverse Events
- Objective Tumor Response
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.
|Study Start Date:||July 2011|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Weekly administration of Sym004
Other Name: Sym004
Please refer to this study by its ClinicalTrials.gov identifier: NCT01417936
|3203; Antwerp University Hospital; Department of Medical Oncology|
|Antwerp, Edegem, Belgium, 2650|
|3202; Jules Bordet Institute; Clinique d'Oncologie Médicale|
|Bruxelles, Belgium, 1000|
|3201; Cliniques Universitaires St-Luc; Centre du Cancer|
|Bruxelles, Belgium, 1200|
|3303; Centre Alexis Vautrin; Département d'Oncologie Médicale|
|Nancy, Vandoeuvre Les Nancy, France, 54111|
|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|