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PNU 214936 IN ADVANCED NON SMALL CELL LUNG CANCER

PNU 214936 IN ADVANCED NON SMALL CELL LUNG CANCER
PNU 214936 用于晚期非小细胞肺癌
批准号：
6303003
负责人：
FRANCISCO ROBERT
金额：
$2.95万
依托单位：
UNIVERSITY OF ALABAMA AT BIRMINGHAM
依托单位国家：
美国
项目类别：
财政年份：
1999
资助国家：
美国
项目状态：
已结题
起止时间：
1999-12-01 至 2000-11-30
来源：
https://reporter.nih.gov/project-details/6303003
关键词：
antineoplastics clinical research clinical trials human subject human therapy evaluation neoplasm /cancer chemotherapy neoplastic growth neoplastic process nonsmall cell lung cancer pharmacokinetics

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中文摘要
翻译
这是一项对晚期非小细胞肺癌患者的重组融合蛋白(突变的SEA超级抗原与识别肿瘤相关糖蛋白5T4的Fab片段连接)PNU-214936的开放标记的I期研究。观察到PNU214936的主要副作用包括一过性高血压发作、发热/寒战和疲劳(最常见的副作用)。本研究的主要目的是通过给晚期非小细胞肺癌患者连续4天的输液来确定PNU-214936的MTD值作为治疗前抗SEA抗体水平的函数。次要目标包括安全性、肿瘤反应、免疫学反应和药代动力学参数。
英文摘要
This is an open-label, phase I study of a recombinant fusion protein (mutated SEA superantigen linked to Fab fragment recognizing a tumor-associated glycoprotein 5T4)  PNU-214936 in patients with advanced non-small cell lung cancer. Primary side effects of PNU214936 observed, included transitory hypertensive episodes, fever/chills and fatigue (most frequent side effects). The primary objective of this study is to determine the MTD of PNU-214936 as a function of pretreatment anti-SEA antibody levels by giving infusions for 4 consecutive days in patients with advanced NSCLC. Secondary objectives includes safety profile, tumor response, immunological response and pharmacokinetic parameters.
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