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: 8350942
• 负责人: DAVID STEWART
• 金额: $ 76.66万
• 依托单位: UNIVERSITY OF TX MD ANDERSON CAN CTR
• 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/8350942
• 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 trial 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第二阶段和早期临床试验 NCI 赞助的药物，用于评估这些药物对其分子的生物学影响 目标，评估其他相关的生物学效应并确定临床相关 结果/相关性。主要重点应放在第二阶段研究、试点方案上 探索有前途的联合疗法，以及对治疗至关重要的高优先级研究 药物开发需要快速启动、完成和数据报告。美国国家癌症研究所-IND 待研究的药剂应包括以下内容： a) 由 制药行业并提供给NCI进行协作开发；和代理商 由学术研究人员和/或发育治疗计划（DTP）开发， DCTD、国家癌症研究所； b) 已完成部分或全部第一阶段测试的代理商，以及： c) 已知各自毒性的药物组合。