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）：NCI已有40多年的历史了，支持了一项临床试验基础设施计划，以在美国进行早期临床试验。随着其增强，促进和加快早期药物开发过程的努力，NCI创建了NCI实验性治疗计划（Next），该计划代表了NCI壁内和外部和机构之间的共同早期治疗性开发计划，以优先确定NCI驱动的目标治疗方法的优先级。 NCI现在已经制定了一项综合计划，以将NCI赞助的合作实验治疗临床试验计划转换为一系列独立的机构，这些机构将进行早期癌症治疗试验进行了早期癌症治疗试验，以新的合并，综合计划，称为NCI实验性治疗治疗方法临床试验（ET-CTN）。匹兹堡大学癌症研究所（UPC）自1990年以来一直是NCI指定的综合癌症中心，UPCI自1999年以来就参与了NCI-U01 I期早期药物开发计划。现在，我们现在建议将新的NCI ET-CTN作为新的领先学术组织的一部分，以实现以下特定的特定目标：（1）单一的实验：1（1）单次实验：1（1） NCI-CTP IND投资组合； （2）参与特定于研究代理的项目团队来定义药物开发计划； （3）研究实验剂的PK/PD方面，并在剂量，时间表，暴露和生物学/抗肿瘤效应之间建立潜在的关系； （4）开发统计上适当的临床试验设计，包括积分和集成生物标志物试验，加速滴定，自适应设计和其他设计方案； （5）调查具有肝和/或肾功能障碍的特殊研究人群； （6）评估来自相关实验室研究的数据，以评估药物与药物相互作用； （7）在研究剂的临床试验中评估转化终点。