NCI ET-CTN with Phase i Emphasis at UPCI

UPCI 重点关注 NCI ET-CTN 第一阶段

基本信息

批准号：
9071388
负责人：
EDWARD CHU
金额：
$ 97.34万
依托单位：
UNIVERSITY OF PITTSBURGH AT PITTSBURGH
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-03-25 至 2020-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9071388
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 Investigational Therapies Joints Kidney Laboratories Lead Leadership National Cancer Institute Pharmaceutical Preparations Phase Process Research Infrastructure Schedule Scheme Series Therapeutic Agents Therapeutic Clinical Trial Titrations University of Pittsburgh Cancer Institute antitumor effect base cancer care cancer therapy design drug development experience interest named group novel novel therapeutics programs study population targeted treatment therapeutic development treatment trial

项目摘要

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. RELEVANCE: As a Lead Academic Organization of the NCI Experimental Therapeutics Clinical Trials Network, the UPCI plans to leverage its significant experience and leadership in early-phase clinical drug development and facilitate the early-phase clinical development of novel therapeutic agents and combinations that are of high priority to the NCI and the national interest. The long-term goal of this effort is to guide future disease specific clinical trials tha may have the potential to change the standard of cancer care in the US and worldwide

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，在美国各地开展早期临床试验。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)，该计划代表 NCI 校内和校外团队/机构之间的联合早期治疗开发计划，优先考虑 NCI 驱动的靶向治疗药物的研发管线。 NCI 目前已制定一项综合计划，将 NCI 资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综合性综合计划，称为 NCI 实验治疗临床试验计划试验网络（ET-CTN）。匹兹堡大学癌症研究所 (UPC) 自 1990 年以来一直是 NCI 指定的综合癌症中心，UPCI 自 1999 年起参与 NCI-U01 I 期早期药物开发计划。我们现在提议成为新的项目的一部分NCI ET-CTN 作为主要学术组织，具有以下具体目标：(1) 使用 NCI-CTP IND 产品组合中的单一或组合新型药物进行早期实验性治疗临床试验； (2) 参与特定研究药物项目组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、时间表、暴露和生物/抗肿瘤作用之间的潜在关系； (4) 开发统计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、适应性设计和其他设计方案； (5) 调查患有肝和/或肾功能障碍的特殊研究人群； (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) 评估研究药物临床试验中的转化终点。相关性：作为 NCI 实验治疗临床试验网络的主要学术组织，UPCI 计划利用其在早期临床药物开发方面的丰富经验和领导力，促进新型治疗药物和组合的早期临床开发，这些药物和组合具有以下特点： NCI 和国家利益高度优先。这项工作的长期目标是指导未来的特定疾病临床试验，这些试验可能有可能改变美国和全世界的癌症护理标准