CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 286 enrolled
Drug / intervention
Zalutumumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00382031
NCT00382031Phase 3Completed

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

Genmab·interventional·Posted Sep 28, 2006·Updated Oct 15, 2013

In Brief

A Phase 3 clinical trial evaluating Zalutumumab and Control for Head and Neck Cancer and Squamous Cell Cancer. Completed, enrolled 286 participants across 82 sites in 12 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Brazil, Canada, Estonia, France, Hungary, Lithuania, Poland, Russia, Serbia, Sweden, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 28, 2006
Enrollment StartNov 1, 2006
Primary CompletionDec 1, 2009
Study CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 19.8 years ago

Interventions

Zalutumumabdrug

Individual dose titration weekly i.v doses

Controlother

Best Supportive Care