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

该合同的目标是进行第二阶段和早期临床试验 NCI申办的药物，以评价这些药物对其分子生物学效应 目标，以评价其他相关生物学效应并确定临床相关 结果/相关性。主要重点应放在第2阶段研究、 探索有前途的联合疗法，以及对以下方面至关重要的高优先级研究 药物开发，需要快速启动，完成和数据报告。NCI-IND 研究的制剂应包括以下内容：a）由 制药行业，并提供给NCI进行合作开发;和代理商 由学术研究者和/或发展治疗计划（DTP）开发， DCTD、NCI; B）已完成部分或全部I期试验的药物，以及：c） 已知单个毒性的药物组合。

The objectives of this contract are to conduct Phase 2 and early clinical trial 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.