Clinical trial · Interventional
Zalutumumab in Non-curable Patients With SCCHN
An Open Label Single Arm Trial Investigating Zalutumumab, a Human Monoclonal Anti-EGF Receptor Antibody, in Combination With Best Supportive Care, in Patients With Non-Curable Squamous Cell Carcinoma of the Head and Neck Who Have Failed Standard Platinum-based Chemotherapy.
NCT00542308CI-TRIAL-00068514completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Treatment, In combination with BSC, Open-label, Single arm, Efficacy Study.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Squamous Cell Cancer | Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Zalutumumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Zalutumumab 4-16 mg/kg
- description
- Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.
- interventionNames
- Drug: Zalutumumab
Primary outcomes (1)
- measure
- Overall Survival (OS)
- timeFrame
- From randomization until death, assessed up to 21 months
- description
- OS was defined as time from start of treatment until date of death of any cause.
Secondary outcomes (3)
- measure
- Objective Tumour Response
- timeFrame
- During treatment and two weeks after end of treatment, assessed up to 21 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Males and females age ≥ 18 years 2. Confirmed diagnosis, initially or at relapse, of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, considered incurable with standard therapy 3. Failure to at least one course of standard platinum-based chemotherapy Exclusion Criteria: 1. Three or more prior chemotherapy regimens 2. Prior treatment with EGFr antibodies and/or EGFr small molecule inhibitors 3. Past or current malignancy other than SCCHN, except for certain other cancer diseases
References
Publications (1)
- DERIVEDSaloura V, Cohen EE, Licitra L, Billan S, Dinis J, Lisby S, Gauler TC. An open-label single-arm, phase II trial of zalutumumab, a human monoclonal anti-EGFR antibody, in patients with platinum-refractory squamous cell carcinoma of the head and neck. Cancer Chemother Pharmacol. 2014 Jun;73(6):1227-39. doi: 10.1007/s00280-014-2459-z. Epub 2014 Apr 9. PMID 24714973