Zalutumumab in Non-curable Patients With SCCHN

Study Overview
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Brief Summary
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Treatment, In combination with BSC, Open-label, Single arm, Efficacy Study.

Official Title
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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.

Conditions
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Head and Neck Cancer, Squamous Cell Cancer

Intervention / Treatment
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* Drug: Zalutumumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females age ≥ 18 years Confirmed diagnosis, initially or at relapse, of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, considered incurable with standard therapy Failure to at least one course of standard platinum-based chemotherapy Exclusion Criteria: Three or more prior chemotherapy regimens Prior treatment with EGFr antibodies and/or EGFr small molecule inhibitors Past or current malignancy other than SCCHN, except for certain other cancer diseases

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zalutumumab 4-16 mg/kg<br>Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred. | Drug: Zalutumumab<br>* Individual dose titration weekly i.v. doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | OS was defined as time from start of treatment until date of death of any cause. | From randomization until death, assessed up to 21 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Tumour Response | Objective Tumour response according to Response Evaluation Criteria in Solid Tumours (RECIST v 1.0). Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR. Stable disease is Responses not fulfilling CR, PR or progressive disease (PD). PD is At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, OR the appearance of one or more new lesions. | During treatment and two weeks after end of treatment, assessed up to 21 months. | 
| Duration of Response | DOR is defined among responders, as the time from the initial documentation of response to the date of disease progression or death, whichever occurs earlier. | During treatment and two weeks after end of treatment, assessed up to 21 months | 
| Progression Free Survival (PFS) | PFS is defined as the time from start of treatment until disease progression or death. | During treatment and two weeks after end of treatment, assessed up to 21 months |