Early Therapeutics Development with Phase II Emphasis

以 II 期为重点的早期治疗开发

• 批准号: 8844862
• 负责人: AMIT OZA
• 金额: $ 79.84万
• 依托单位: UNIVERSITY HEALTH NETWORK
• 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 2014-09-22
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8844862
• 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。