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: 8497528
• 负责人: CHARLES ERLICHMAN
• 金额: $ 119.13万
• 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 2013-09-22
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8497528
• 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。