Phase I Molecular and Clinical Pharmacodynamic Trials ET-CTN

I 期分子和临床药效试验 ET-CTN

• 批准号: 8725881
• 负责人: HEINZ JOSEF LENZ
• 金额: $ 90.07万
• 依托单位: BECKMAN RESEARCH INSTITUTE/CITY OF HOPE
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-03-28 至 2019-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8725881
• 关键词: Antineoplastic Agents; Area; Award; Bioinformatics; Biological Markers; California; Cancer Center; Cancer Therapy Evaluation Program; Cell Cycle Regulation; City of Hope Comprehensive Cancer Center; Clinic; Clinical; Clinical Trials; Clinical Trials Network; Collection; Complex; Comprehensive Cancer Center; Contracts; Correlative Study; Development; Dose; Drug Kinetics; Drug Targeting; Faculty; Fostering; Funding; Future; Goals; Guidelines; Histology; Human; In Vitro; Individual; Institution; Investigational Drugs; Laboratories; Laboratory Study; Lead; Learning; Malignant Neoplasms; Mentors; Methodology; Modeling; Molecular; Molecular Profiling; Molecular Target; National Cancer Institute; Normal tissue morphology; Outcome; Participant; Pathway interactions; Patients; Pattern; Pharmaceutical Preparations; Pharmacodynamics; Pharmacogenomics; Pharmacology; Phase; Phase I Clinical Trials; Pre-Clinical Model; Procedures; Process; Productivity; Qualifying; Recording of previous events; Research Design; Research Infrastructure; Research Personnel; Resistance; Resources; Sampling; Schedule; Science; Scientist; Signal Transduction; Site; Teacher Professional Development; Therapeutic; Therapeutic Clinical Trial; Time; Tissue Sample; Toxic effect; Training; Training Programs; U-Series Cooperative Agreements; Universities; Validation; Work; base; cancer therapy; career development; drug development; in vivo; innovation; insight; interest; member; multidisciplinary; neoplastic cell; non-invasive imaging; novel; pre-clinical; programs; response; success; translational study; tumor; tumor xenograft

DESCRIPTION (provided by applicant): The purpose of this UM1 Cooperative Agreement is to support participation by a consortium of three National Cancer Institute (NCl)-Designated Cancer Centers in a consolidated, integrated NCI Experimental Therapeutics-Clinical Trials Network (ET-CTN) to conduct early phase experimental therapeutics clinical trials. The Consortium of the City of Hope Comprehensive Cancer Center (COH, the "Lead Academic Organization," [LAO]), The University of Southern California (USC)/Norris Comprehensive Cancer Center (USC, Associate Organization [AO]) and the University of California, Davis Cancer Center (UCD, AO) has a 20-year history as a multidisciplinary group conducting early phase experimental therapeutics clinical trials of NCI-Sponsored Investigational New Drugs (INDs) under UOl Cooperative Agreements and NOI Contracts. In addition to working within our own Consortium, we have developed collegial arrangements with other U01 and N01 holders to take advantage of their specific expertise and more efficiently complete clinical trials. Our consortium will contribute to ET-CTN agent-specific trans-network drug development teams from the combined expertise of COH, USC, and UCD in the areas of molecular pharmacology, pharmacokinetics, pharmacodynamics, pharmacogenomics, signal transduction, cell cycle regulation, non-invasive imaging, and bioinformatics to conduct innovative, laboratory-directed early phase developmental and pharmacokinetic studies. These early phase studies will lead not only to the assignment of a recommended, biologically effective Phase II dose, and to an understanding of the spectrum of normal tissue toxicity for specific antineoplastic agents that are directed against novel molecular pathways, but will also provide a mechanistic validation of the effects of the agents on critical tumor cell targets, correlate drug-related alterations of tumr and host biologic markers with clinical outcome, and develop new insights into the therapeutic mechanism of action of the compounds both in the laboratory and the clinic. As such, they will advance the ET-CTN overall goal to define better approaches to the development of novel anticancer agents that capitalize on the ability to characterize tumors molecularly and find appropriate biomarkers to select patients most likely to respond to specific agents.

描述（由申请人提供）：本UM 1合作协议的目的是支持由三个国家癌症研究所（NCI）指定的癌症中心组成的联盟参与统一的、综合的NCI实验治疗-临床试验网络（ET-CTN），以进行早期实验治疗临床试验。希望之城综合癌症中心（City of Hope Comprehensive Cancer Center）（COH，“领导学术组织”，[LAO]），南加州大学（USC）/诺里斯综合癌症中心（南加州大学，联合组织[AO]）和加州大学戴维斯癌症中心（UCD，AO）作为一个多学科小组进行NCI的早期实验治疗临床试验已有20年的历史，根据UOI合作协议和NOI合同申办的研究性新药（IND）。除了在我们自己的联盟内工作外，我们还与其他U 01和N 01持有者建立了合议安排，以利用他们的专业知识，更有效地完成临床试验。我们的联盟将有助于ET-CTN代理特定的跨网络药物开发团队从COH，USC和UCD在分子药理学，药代动力学，药效学，药物基因组学，信号转导，细胞周期调控，非侵入性成像和生物信息学领域的综合专业知识进行创新，实验室指导的早期开发和药代动力学研究。这些早期研究将不仅导致分配推荐的、生物学有效的II期剂量，并理解针对新分子途径的特异性抗肿瘤剂的正常组织毒性谱，而且还将提供药物对关键肿瘤细胞靶点的作用的机制验证，将药物相关的肿瘤和宿主生物标志物的改变与临床结果相关联，并在实验室和临床中对化合物的治疗作用机制提出新的见解。因此，他们将推进ET-CTN的总体目标，以确定开发新型抗癌药物的更好方法，这些药物利用分子表征肿瘤的能力，并找到适当的生物标志物来选择最有可能对特定药物产生反应的患者。