A Randomized, Multicentre Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Proxinium Plus Best Supportive Care Versus Best Supportive Care Alone in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck Who Have Received at Least One Anti-Cancer Treatment Regimen for Advanced Disease
Head and neck cancer is a general description of a disease that includes several types of
soft tissue carcinomas that develop in the head and neck regions.
Proxinium is a recombinant fusion protein that binds to the epithelial cell adhesion
molecule (Ep-CAM) that is highly expressed on squamous cell carcinomas of the head and neck
(SCCHN). Proxinium is administered via intratumoural injection.
The primary objective of the study is to compare the overall survival time for patients
treated with intratumourally injected Proxinium plus BSC versus BSC alone. Secondary
objectives of the study include comparison of locoregional tumour control, local
progression-free survival, symptomatic benefit and safety profile in patients who receive
Proxinium plus BSC versus patients who receive BSC
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Death or 12 months from the date that the last patient required for efficacy analysis has been randomized
Viventia Biotech Inc.
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica