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: 8544374
• 负责人: DANIEL M SULLIVAN
• 金额: $ 73.51万
• 依托单位: H. LEE MOFFITT CANCER CTR & RES INST
• 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/8544374
• 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.

本合同的目的是对NCI申办的药物进行II期和早期临床试验，以评价这些药物对其分子靶点的生物学效应，评价其他相关生物学效应，并确定临床相关结局/相关因素。重点应放在2期研究、探索有前景的联合治疗的试点方案以及对药物开发至关重要且需要快速启动、完成和数据报告的高优先级研究上。待研究的NCI-IND药物应包括以下内容：a）由制药行业开发并提供给NCI进行合作开发的药物;以及由学术研究者和/或开发治疗计划（DTP）、DCTD、NCI开发的药物; B）已完成部分或全部I期测试的药物，以及：c）已知个体毒性的药物组合。