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TAS::75 0849::TAS EARLY THERAPEUTICS DEVELOPMENT WITH PHASE II EMPHASIS

TAS::75 0849::TAS EARLY THERAPEUTICS DEVELOPMENT WITH PHASE II EMPHASIS
TAS::75 0849::TAS 早期治疗开发,重点是 II 期
批准号:
8481459
负责人:
DAVID STEWART
金额:
$117.05万
依托单位国家:
美国
项目类别:
财政年份:
2011
资助国家:
美国
项目状态:
已结题
起止时间:
2011-09-23 至 2013-09-22

项目摘要

项目成果

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中文摘要
翻译
该合同的目标是开展nci赞助的药物的2期和早期临床试验,评估这些药物对其分子靶点的生物效应,评估其他相关的生物效应,并确定临床相关的结果/相关性。重点应放在2期研究、探索有前景的联合疗法的试点方案,以及对药物开发至关重要的高优先级研究,这些研究需要快速启动、完成和数据报告。研究的NCI- ind制剂应包括:a)由制药行业开发并提供给NCI合作开发的制剂;以及由学术研究者和/或发育治疗项目(DTP)、DCTD、NCI开发的药物;b)已完成部分或全部I期试验的药剂;c)个别毒性已知的药剂组合。
英文摘要
The objectives of this contract are to conduct Phase 2 and early clinical trials of NCI-sponsored agents, to evaluate biologic effects of these agents on their molecular targets, to evaluate other relevant biologic effects and to determine clinically relevant outcomes/correlates. Major emphasis shall be on Phase 2 studies, pilot protocols that explore promising combination therapies, and high priority studies that are pivotal for drug development and require rapid initiation, completion, and data reporting. The NCI-IND agents to be studied shall include the following: a) Agents developed by the pharmaceutical industry and provided to the NCI for collaborative development; and agents developed by academic investigators and/or the Developmental Therapeutics Program (DTP), DCTD, NCI; b) Agents which have completed some or all Phase I testing, and: c) Combinations of agents for which the individual toxicities are known.
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EARLY THERAPEUTICS DEVELOPMENT WITH PHASE II EMPHASIS
EARLY THERAPEUTICS DEVELOPMENT WITH PHASE II EMPHASIS
EARLY THERAPEUTICS DEVELOPMENT WITH PHASE II EMPHASIS
TAS::75 0849::TAS EARLY THERAPEUTICS DEVELOPMENT WITH PHASE II EMPHASIS
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