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Study of Proxinium Plus Best Supportive Care Versus Best Supportive Care for Patients With Advanced Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:
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 SCCHN Who Have Received at Least One Anti-cancer Treatment Regimen for Advanced Disease

Clinical Trial Summary

The purpose of this study is to compare the safety and efficacy of Proxinium plus best supportive care with best supportive care only for patients with squamous cell head and neck cancer.

Clinical Trial Description

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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00412776
Study type Interventional
Source Viventia Bio
Contact
Status Terminated
Phase Phase 2/Phase 3
Start date December 2005
Completion date April 2008
View Details
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