An Open-labeled, 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

Genmab A/S0 个研究点目标入组 273 人开始时间: 2006年9月5日最近更新: 2012年4月3日

试验速览

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•1) Squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, considered incurable with standard therapy
•2) Progressive disease according to RECIST confirmed by an IRC during or within 6 months after failure or intolerance to standard platinum-based chemotherapy
•3) Measurable disease according to RECIST confirmed by IRC
•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
•3) Received the following treatments within 4 weeks prior to Visit 2:
•- Cytotoxic or cytostatic anti-cancer chemotherapy
•- Total tumor resection

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