At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 28 enrolled
Drug / intervention
Zalutumumabdrug
Likely dose
Zalutumumab weekly infusionAI-extracted
Key inclusion· 3
- ✓Histologically confirmed squamous cell carcinoma of the head and neck (oral cavity, nasal cavity, paranasal sinuses, nasopharynx, oropharynx, hypopharynx, or larynx).
- ✓Recurrent or metastatic disease with no curative or established palliative treatment options available.
- ✓WHO performance status of 1 or 2.
Key exclusion· 9
- ✕Receipt of certain other treatments within 4 weeks prior to study drug administration.
- ✕Previous severe allergic reactions (angioedema, severe asthma, anaphylaxis).
- ✕Skin disease requiring systemic or local corticosteroid therapy.
- ✕Known brain metastasis or leptomeningeal disease.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open, Single Dose Escalation Study Followed by a Multiple Dose Extension of Anti-EGF Receptor Human Monoclonal Antibody (Zalutumumab) in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
In Brief
A Phase 2 clinical trial evaluating Zalutumumab for Head and Neck Neoplasms. Completed, enrolled 28 participants across 5 sites in 2 countries.
Detailed Summary
The purpose of this trial is to determine the safety of zalutumumab as a treatment for head and neck cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead and Neck Neoplasms
CountriesDenmark, Sweden
Collaborators--
Timeline
Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2003
First PostedOct 2004
Primary CompletionJan 2005
TodayJul 2026
First PostedOct 1, 2004
Enrollment StartDec 1, 2003
Primary CompletionJan 12, 2005
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 21.8 years ago
Interventions
Zalutumumabdrug
Weekly infusion