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PHASE I STUDY OF CP 358,774 IN SUBJECTS W/ ADVANCED SOLID TUMORS

PHASE I STUDY OF CP 358,774 IN SUBJECTS W/ ADVANCED SOLID TUMORS
CP 358,774 在晚期实体瘤受试者中的 I 期研究
批准号：
6586828
负责人：
ERIC K ROWINSKY
金额：
$23.48万
依托单位：
UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
依托单位国家：
美国
项目类别：
财政年份：
2001
资助国家：
美国
项目状态：
已结题
起止时间：
2001-12-01 至 2002-11-30
来源：
https://reporter.nih.gov/project-details/6586828
关键词：
antineoplastics clinical research clinical trial phase I dosage drug administration rate /duration drug adverse effect epidermal growth factor growth factor receptors human subject human therapy evaluation neoplasm /cancer chemotherapy neoplastic growth pharmacokinetics

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中文摘要
翻译
这是一项CP-358,774的开放标签、剂量和方案升级研究，CP-358,774是一种新型抗癌药物，可抑制表皮生长因子受体(EGFR)酪氨酸激酶的活性，从而抑制表达EGFR的肿瘤的生长。本研究的目的是评估晚期癌症患者每日服用CP-358,774的安全性、耐受性、药代动力学和最大耐受量。这项研究的第二个目标是使用经过验证的临床终点评估研究药物每日剂量的抗肿瘤活性。这项研究有三个顺序治疗腿，结合了不同的给药频率。
英文摘要
This is an open-label, dose and regimen escalation study of CP-358,774, a novel anti-cancer agent which inhibits epidermal growth factor receptor (EGFR) tyrosine kinase actvity and thus inhibits the growth of human EGFR-expressing tumors. The purpose of the study is to evluate the safety, toleration, pharmacokinetics and maximum tolerated dose of daily administration of CP-358,774 to patients with advanced cancers. A secondary objective of the study is to evaluate the anti-tumor activity of daily dosing of the study drug, using validated clinical endpoints. The study has three sequential treatment legs incorporating different frequencies of administration.
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