EARLY THERAPEUTICS DEVELOPMENT WITH PHASE II EMPHASIS

以第二阶段为重点的早期治疗开发

• 批准号: 8352528
• 负责人: CHARLES ERLICHMAN
• 金额: $ 94.02万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-23 至 2012-09-22
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8352528
• 关键词: Clinical Trials; Combined Modality Therapy; Contracts; Data Reporting; Development; Developmental Therapeutics Program; Drug Industry; Individual; Molecular Target; Outcome; Phase; Protocols documentation; Research Personnel; Testing; Toxic effect; clinically relevant; drug development; phase 2 study; therapeutic development

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.

该合同的目标是进行NCI赞助的药物的第2阶段和早期临床试验，以评估这些药物对它们的分子靶标的生物学效应，以评估其他相关的生物学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，探索有希望的组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，需要快速启动，完成和数据报告。 NCI-IND要研究的代理应包括以下内容：a）制药行业开发的代理商并向NCI提供合作开发；以及由学术研究人员和/或DCTD，NCI开发的代理商和/或开发治疗计划（DTP）； b）已经完成了某些或全阶段测试的药物，以及：c）已知个体毒性的药物组合。