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

TAS::75 0849::TAS 早期治疗开发，重点是 II 期

• 批准号: 8499157
• 负责人: DAVID R GANDARA
• 金额: $ 109.1万
• 依托单位: UNIVERSITY OF CALIFORNIA AT DAVIS
• 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/8499157
• 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.

该合同的目标是对 NCI 赞助的药物进行 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结果/相关性。主要重点应放在二期研究、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并需要快速启动、完成和数据报告的高优先级研究。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合作开发的药物；以及由学术研究人员和/或发展治疗计划 (DTP)、DCTD、NCI 开发的药物； b) 已完成部分或全部 I 期测试的药剂，以及： c) 已知各自毒性的药剂组合。