NCI ET-CTN with Phase i Emphasis at UPCI

UPCI 重点关注 NCI ET-CTN 第一阶段

• 批准号: 8725328
• 负责人: EDWARD CHU
• 金额: $ 85.07万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-03-25 至 2019-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8725328
• 关键词: Biological; Biological Markers; Cancer Therapy Evaluation Program; Clinical; Clinical Drug Development; Clinical Trials; Clinical Trials Design; Clinical Trials Network; Comprehensive Cancer Center; Data; Development; Development Plans; Disease; Dose; Drug Interactions; Extramural Activities; Functional disorder; Future; Goals; Hepatic; Institution; Joints; Kidney; Laboratories; Lead; Leadership; National Cancer Institute; Pharmaceutical Preparations; Phase; Population Study; Process; Research Infrastructure; Schedule; Scheme; Series; Therapeutic; Therapeutic Agents; Therapeutic Clinical Trial; Titrations; University of Pittsburgh Cancer Institute; base; cancer care; cancer therapy; design; drug development; experience; interest; named group; novel; novel therapeutics; programs; therapeutic development; therapeutic target; treatment trial

DESCRIPTION (provided by applicant): For more than 40 years, the NCI has supported a clinical trials infrastructure program to conduct early phase clinical trials across the US. As par of its efforts to enhance, facilitate, and expedite the process of early-phase drug development, the NCI created the NCI Experimental Therapeutics Program (NExT), which represents a joint early therapeutics development program between NCI intramural and extramural teams/institutions to prioritize a pipeline of NCI-driven targeted therapeutics. The NCI has now developed a comprehensive plan to transform the NCI-sponsored cooperative experimental therapeutics clinical trials program from a series of separate institutions conducting early-phase cancer treatment trials to a new consolidated, integrated Program, referred to as the NCI Experimental Therapeutics-Clinical Trials Network (ET-CTN). The University of Pittsburgh Cancer Institute (UPC) has been an NCI-designated comprehensive cancer center since 1990, and the UPCI has been involved in the NCI-U01 Phase I Early Drug Development Program since 1999. We now propose to be part of the new NCI ET-CTN as a Lead Academic Organization with the following specific aims: (1) to conduct early-phase experimental therapeutic clinical trials using single or combinations of novel agents from the NCI-CTP IND portfolio; (2) to participate on investigational agent-specific Project Teams to define the drug development plan; (3) to investigate the PK/PD aspects of the experimental agents and establish potential relationships between dose, schedule, exposure, and biological/antitumor effect; (4) to develop statistically appropriate clinical trial designs, including integral and integrated biomarker trials, accelerated titration, adaptive designs, and other design schemes; (5) to investigate special study populations with hepatic and/or renal dysfunction; (6) to evaluate data from related laboratory-based studies that assess drug-drug interactions; and (7) to evaluate translational endpoints in clinical trials of investigational agents.

描述（由申请人提供）：40多年来，NCI一直支持临床试验基础设施计划，在美国各地进行早期临床试验。作为加强、促进和加快早期药物开发过程的努力的一部分，NCI创建了NCI实验治疗计划（NExT），这是NCI内部和外部团队/机构之间的联合早期治疗开发计划，以优先考虑NCI驱动的靶向治疗。NCI现在已经制定了一项全面的计划，将NCI赞助的合作实验治疗临床试验计划从一系列进行早期癌症治疗试验的独立机构转变为一个新的合并的综合计划，称为NCI实验治疗-临床试验网络（ET-CTN）。匹兹堡大学癌症研究所（UPC）自1990年以来一直是NCI指定的综合性癌症中心，UPCI自1999年以来一直参与NCI-U 01 I期早期药物开发计划。我们现在建议成为新的NCI ET-CTN的一部分，作为牵头学术组织，具有以下具体目标：（1）使用NCI-CTP IND组合中的单一或组合新药进行早期实验性治疗临床试验;（2）参与研究药物特定项目团队，以确定药物开发计划;（3）研究实验药物的PK/PD方面，并建立剂量、方案、暴露和生物学/抗肿瘤作用之间的潜在关系;（4）开发统计学上适当的临床试验设计，包括整体和综合生物标志物试验，加速滴定，适应性设计，及其他设计方案;（5）调查肝和/或肾功能不全的特殊研究人群;（6）评价来自评估药物相互作用的相关实验室研究的数据;（7）评价研究药物临床试验中的转化终点。