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 SCCH
- Conditions
- on-Curable Squamous Cell Carcinoma of the Head and NeckMedDRA version: 9.1Level: LLTClassification code 10060121Term: Squamous cell carcinoma of head and neck
- Registration Number
- EUCTR2008-000582-39-CZ
- Lead Sponsor
- Genmab A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
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
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
Name Time Method