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. - Zalutumumab in non-curable Patients with SCCHN

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-000582-39-SK

Enrollment

100

Registered

2008-06-19

Start date

2008-09-18

Completion date

Unknown

Last updated

2022-04-19

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: 9.1 Level: LLT Classification code 10060121 Term: Squamous cell carcinoma of head and neck

Interventions

Product Name: 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

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. Patients must have disease progression according to RECIST. 3. Measurable disease defined as one or more target lesions according to RECIST. 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

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 unless given as part of first line treatment of locally or regionally advanced SCCHN in combination with chemotherapy and/or radiotherapy. Exposure to EGFr targeted therapy must be completed = 6 weeks prior to visit 2 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 zalutumumab in combination with BSC in terms of overall survival in non-curable patients with recurrent and/or metastatic disease who have failed after at least one course of standard-based chemotherapy.;Secondary Objective: To investigate zalutumumab in combination with BSC with respect to efficacy and safety and to determine the pharmacokinetic profile of zalutumumab.;Primary end point(s): Overall Survival (OS) defined as the time from start of treatment until date of death from any cause.	—

Measure

Time frame

Main Objective: To investigate zalutumumab in combination with BSC in terms of overall survival in non-curable patients with recurrent and/or metastatic disease who have failed after at least one course of standard-based chemotherapy.;Secondary Objective: To investigate zalutumumab in combination with BSC with respect to efficacy and safety and to determine the pharmacokinetic profile of zalutumumab.;Primary end point(s): Overall Survival (OS) defined as the time from start of treatment until date of death from any cause.

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Countries

Austria, Czech Republic, Germany, Italy, Portugal, Slovakia

Outcome results

None listed

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