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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-002472-17-BE

Enrollment

273

Registered

2006-07-12

Start date

2007-06-19

Completion date

Unknown

Last updated

2012-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Belgium, Estonia, France, Hungary, Lithuania, Spain, Sweden, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026