An Open-labeled, 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 SCCH

• Conditions: on-Curable Squamous cell carcinoma of the head and neck (SCCHN); MedDRA version: 8.1Level: LLTClassification code 10060121Term: Squamous cell carcinoma of head and neck

• Registration Number: EUCTR2006-002472-17-SE
• Lead Sponsor: Genmab A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07-24
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 273

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 confirmed by an IRC during or within 6 months after failure or intolerance to standard platinum-based chemotherapy

3) Measurable disease according to RECIST confirmed by IRC

4) WHO PS=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

Exclusion Criteria

1) Three or more prior chemotherapy regimens other than platinum based chemotherapy

2) Prior treatment with EGFr antibodies and/or EGFr small molecule inhibitors

3) Received the following treatments within 4 weeks prior to Visit 2:

? Cytotoxic or cytostatic anti-cancer chemotherapy
? Total tumor resection

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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;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;Primary end point(s): Overall Survival (OS) defined as the time from randomization until date of death from any cause.