NCT00382031

Zalutumumab in Patients With Non-curable Head and Neck Cancer

An Open-Labeled Randomized Parallel Group Trial of Zalutumumab, a Human Monoclonal Anti-EGFr Antibody, in Combination With Best Supportive Care (BSC) vs BSC, in Pts With Non-Curable SCCHN Who Have Failed Standard Platinum-Based Chemotherapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 286 (actual)
• Sponsor: Genmab · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate if zalutumumab in combination with Best Supportive Care (BSC) is superior to BSC in non-curable patients with head and neck cancer

Detailed description

This is an open parallel group trial. Patients will be randomized in a 2:1 manner to receive either treatment with zalutumumab in combination with Best Supportive Care (BSC) or BSC. Patients randomized to treatment with zalutumumab in combination with BSC will receive weekly infusions with zalutumumab starting with a loading dose (8mg/kg) followed by weekly maintenance doses until disease progression, intercurrent illness preventing further administration, unacceptable toxicity or patient decision. After Visit 2 the patient should be evaluated for presence of skin rash prior to each infusion to allow dose titration. Individual dose titration until the patient develops grade 2 skin rash will be applied. The maximum dose used in study will be 16 mg/kg.

Conditions

• Head and Neck Cancer
• Squamous Cell Cancer

Interventions

Type	Name	Description
DRUG	Zalutumumab	Individual dose titration weekly i.v doses
OTHER	Control	Best Supportive Care

Timeline

• Start date: 2006-11-01
• Primary completion: 2009-12-01
• Completion: 2011-08-01
• First posted: 2006-09-28
• Last updated: 2013-10-15
• Results posted: 2013-10-15

Locations

82 sites across 12 countries: Belgium, Brazil, Canada, Estonia, France, Hungary, Lithuania, Poland, Russia, Serbia, Sweden, United Kingdom