An Open-labelled, Randomized, Parallel Group Trial of zalutumumab, a Human Monoclonal Anti-EGF receptor Antibody, in combination with Best Supportive Care, versus Best Supportive Care, in Patients with Non-Curable Squamous Cell Carcinoma of the Head and Neck who have failed standard platinum-based chemotherapy. - zalutumumab in non-curable patients with SCCHN

INTERVENTION: Product Name: HuMax‐EGFr (zalutumumab) Product Code: HuMax EGFr Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: zalutumumab CAS Number: 667901‐13‐5 Current Sponsor code: HuMax‐EGFr Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20‐ CONDITION: Non‐Curable Squamous cell carcinoma of the head and neck (SCCHN) ; MedDRA version: 8.1 Level: LLT Classification code 10060121 Term: Squamous cell carcinoma of head and neck PRIMARY OUTCOME: Main Objective: To investigate if HuMax‐EGFr in combination with Best Supportive Care (BSC) is superior to BSC in terms of overall survival in non‐curable patients with recurrent and/or metastatic disease who have failed at least one course of standard platinum‐based chemotherapy Primary end point(s): Overall Survival (OS) defined as the time from randomization until date of death from any cause. Secondary Objective: To compare HuMax‐EGFr in combination with BSC to BSC with respect to efficacy, safety and Quality of Life (QoL) and to determine the pharmacokinetic profile of HuMax‐EGFr INCLUSION CRITERIA: 1) Squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, considered incurable with standard therapy 2) Progressive disease according to RECIST by an IRC during or within 6 months after failure or intolerance to standard platinium‐based chemotherapy 3) Measurable disease according to RECIST confirmed by IRC 4) WHO performance status = 2 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range