EARLY THERAPEUTICS DEVELOPMENT WITH PHASE II EMPHASIS

该合同的目标是进行NCI赞助的药物的第二阶段和早期临床试验，评估这些药物对其分子靶标的生物效应，评估其他相关的生物效应，并确定临床相关的结果/相关性。主要重点应放在第二阶段研究，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、需要快速启动、完成和数据报告的高优先级研究。拟研究的NCI-IND药物应包括：a)由制药行业开发并提供给NCI用于合作开发的药物；以及由学术研究人员和/或开发治疗计划(DTP)、DCTD、NCI开发的药物；b)已完成部分或全部第一阶段测试的药物；以及：c)已知个别毒性的药物组合。

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.