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CetuGEX™ in Comparison to Cetuximab for the Treatment of Patients With Head and Neck Cancer — RESGEX  

Carcinoma, Squamous Cell of Head and Neck Clinical Trial

Official title:
Randomized, Controlled, Open Label, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of CetuGEX™ Plus CT in Comparison to Cetuximab Plus CT in Patients With Stage III/IV Recurrent and/or Metastatic SCCHN

Clinical Trial Summary

The aim of the study is to evaluate the efficacy of CetuGEX™ for the treatment of patients with stage III/IV recurrent and/or metastatic SCCHN as compared to cetuximab (both in combination with platinum-based chemotherapy) in terms of progression-free survival (PFS).

Clinical Trial Description

Indication: First line systemic treatment for stage III/IV recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) Primary Objective: To evaluate the efficacy of CetuGEX™ for the treatment of patients with stage III/IV recurrent and/or metastatic SCCHN as compared to cetuximab (both in combination with platinum-based chemotherapy) in terms of progression-free survival (PFS). Secondary Objectives: To evaluate further efficacy criteria, safety and quality of life (QoL) of patients with stage III/IV recurrent and/or metastatic SCCHN treated with CetuGEX™ as compared to cetuximab (both in combination with platinum-based chemotherapy). To assess pharmacokinetic (PK) parameters and profiles of CetuGEX™. To assess efficacy and safety based on genetic markers for immune response (Fc-gamma receptor [FcγR] allotypes) and biomarkers (exploratory only). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02052960
Study type Interventional
Source Glycotope GmbH
Contact
Status Completed
Phase Phase 2
Start date February 2014
Completion date October 4, 2017
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See also
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