An Open label single arm trial investifating 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 Failes 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: 9.1Level: LLTClassification code 10060121Term: Squamous cell carcinoma of head and neck

Registration Number: EUCTR2008-000582-39-AT

Lead Sponsor: Genmab A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

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 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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures