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SAFETY STUDY OF RECOMBINANT MONOCLONAL ANTIBODY

SAFETY STUDY OF RECOMBINANT MONOCLONAL ANTIBODY
重组单克隆抗体的安全性研究
批准号：
6264180
负责人：
ADAM M BRUFSKY
金额：
$0.3万
依托单位：
UNIVERSITY OF PITTSBURGH AT PITTSBURGH
依托单位国家：
美国
项目类别：
财政年份：
1998
资助国家：
美国
项目状态：
已结题
起止时间：
1998-12-01 至 1999-11-30
来源：
https://reporter.nih.gov/project-details/6264180
关键词：
breast neoplasms clinical research clinical trial phase I human subject human therapy evaluation monoclonal antibody neoplasm /cancer immunotherapy recombinant proteins

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中文摘要
翻译
本方案描述了一项在约500例接受两种或多种细胞毒性化疗方案治疗转移性乳腺癌后复发的HER2过表达患者中进行的重组人源化抗p185 HER2单克隆抗体（rhuMAb HER2）的多中心、扩大使用、开放标签安全性研究。 由于可用的药物供应非常有限，将根据每季度入组100例患者的假设，通过抽签随机选择符合条件的患者，持续5个季度。本研究将涉及不同地理位置的研究中心，以便广泛使用这种新药。 在筛选合格性后，国家中心研究所治疗转诊中心将把患者转诊到最近的参与中心。
英文摘要
This protocol describes a multicenter expanded access open label safety study of recombinant humanized anti-p185 HER2 monoclonal antibody (rhuMAb HER2) in approximately 500 patients with HER2 overexpression who have relapsed following two or more cytotoxic chemotherapy regimens for metastatic breast cancer. Due to the very limited drug supply available, eligible patients will be randomly selected by lottery based on an enrollment assumption of 100 patients per quarter for five quarters. Geographically diversed centers will be involved in the study in order to allow widespread availability of this new agent. Following screening for eligibility, the National Center Institutes Treatment Referral Center will refer patietns to the closest participating center.
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NCI NCTN-Network Lead Academic Participating Site at UPMC Hillman Cancer Center
NCI NCTN-Network Lead Academic Participating Site at UPMC Hillman Cancer Center
NCI NCTN-Network Lead Academic Participating Site at UPMC Hillman Cancer Center
NCI NCTN-Network Lead Academic Participating Site at UPMC Hillman Cancer Center
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