drugset / Trial / NCT01012258

Cetuximab With Radiotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck in Chinese Subjects

NCT01012258

Phase 3 Completed 70 enrolled Merck KGaA, Darmstadt, Germany
NaSingle-groupOpen-labelTreatment

Summary

Primary objective: to assess the antitumor activity and safety profile of cetuximab when given in combination with radiotherapy (RT) for the treatment of locally advanced squamous cell carcinoma of the head and neck (SCCHN) in Chinese subjects. Secondary objective: to assess the pharmacokinetic (PK) profile and immunogenicity of cetuximab in Chinese subjects. Further objective: to identify for cetuximab potential predictive biomarkers of response and safety.

Timeline

Start
2009-02
Primary completion
2010-09
Completion
2014-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody 250 mg/m2 Intravenous