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 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-BE
- Lead Sponsor
- Genmab A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 273
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
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
- Secondary Outcome Measures
Name Time Method