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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
该方案描述了一项多中心扩展开放标签安全性研究，该研究在大约500名HER2过表达患者中进行了重组人源化抗p185 HER2单克隆抗体（rhuMAb HER2），这些患者在接受两种或多种细胞毒性化疗方案后复发。由于可获得的药物供应非常有限，符合条件的患者将根据每个季度100名患者的登记假设随机抽取，为期5个季度。地理上不同的中心将参与这项研究，以便广泛使用这种新药物。在筛选合格后，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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