ViKTriY Early Clinical Trials Consortium (ECTC)

ViKTriY 早期临床试验联盟 (ECTC)

• 批准号: 8890125
• 负责人: PATRICIA M. LORUSSO
• 金额: $ 153.52万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-07-10 至 2019-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8890125
• 关键词: Address; Adult; Antineoplastic Agents; Area; Berlin; Biochemical Pathway; Bioinformatics; Biological; Biological Assay; Biological Markers; Biology; Biometry; Biopsy; Cancer Center; Cancer Patient; Clinical; Clinical Pharmacology; Clinical Research; Clinical Trials; Clinical Trials Design; Clinical Trials Network; Data; Decision Making; Development; Disease; Doctor of Medicine; Doctor of Philosophy; Dose; Dose-Limiting; Drug Kinetics; Drug effect disorder; Elements; Functional disorder; Genomics; Goals; Grant; Image; Imaging Device; Immune; Immunology; Institutes; Institution; Jordan; Lead; Leadership; Malignant Neoplasms; Maximum Tolerated Dose; Mentors; Mentorship; Minority; Mission; Molecular; Mutation; Organ; Outcome; Patient Selection; Patients; Pharmaceutical Preparations; Pharmacodynamics; Pharmacogenomics; Pharmacology; Phase; Phase I Clinical Trials; Philosophy; Population; Positioning Attribute; Principal Investigator; Proteomics; Recommendation; Recruitment Activity; Regimen; Relative (related person); Reporting; Research; Research Infrastructure; Research Institute; Research Personnel; Resistance; Schedule; Solid Neoplasm; Staging; The Vanderbilt-Ingram Cancer Center at the Vanderbilt University; Therapeutic; Therapeutic Clinical Trial; Toxic effect; Translational Research; Underrepresented Minority; Universities; Work; Yale Cancer Center; base; bench to bedside; cytotoxic; design; drug development; experience; improved; medical specialties; member; multidisciplinary; named group; next generation; non-invasive imaging; novel; novel therapeutics; programs; research facility; response; small molecule; success; targeted treatment; therapy development; tool; translational study; treatment response; trial design; tumor

DESCRIPTION (provided by applicant): Results from early phase clinical trials have been the cornerstone upon which Phase 2 and 3 efforts are constructed, and upon which scientific inference relative to the biological basis for drug action is imputed. This new era in drug development-an era of molecularly targeted treatments-represents a paradigm shift in how early phase studies are considered relative to the "conventional" approach of treating without consideration to underlying tumor genomics, biology and immunology. Translational endpoints, including levels of target expression, engagement, and modulation of downstream effectors are being assessed as early as possible, and increasing emphasis is being placed on early patient selection, utilizing novel biomarker assays and molecular characterization to identify patients most likely to respond. The ultimate purpose of the NCI Experimental Therapeutics-Clinical Trials Network (ET-CTN) is to define better approaches for 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. The goals of the ET-CTN cannot be achieved by any single investigator or institution and will require collaborative, diverse, and committed members with complementary expertise. To assemble the synergistic expertise required to assist ET-CTN in reaching its goals, a comprehensive team has been formed to perform clinical and translational research in this new era of drug development. This team aims to 1) conduct carefully-controlled early clinical trials of novel anticancer agents and combinations; 2) recruit at least 12% underserved/special populations; 3) study the clinical pharmacology, pharmacokinetics, pharmacodynamics, and pharmacogenomics of novel agents, and where appropriate, incorporate noninvasive imaging tools; and 4) utilize biomarker assays and advanced molecular characterization tools to identify molecular factors associated with treatment response and resistance. The members of this team have a unique set of complementary expertise and a similar philosophy regarding collaborative research and mentorship of the next generation of cancer investigators. This partnership has been termed the Vanderbilt-lngram, Karmanos, TGen Research Institute, Yale - Early Cancer Therapeutics Consortium (ViKTriY - ECTC). This ViKTriY team is committed to utilizing their areas of expertise and maximizing their collaborative relationships with the ultimate mission of improving outcomes for patients with cancer. RELEVANCE: This application describes a multidisciplinary team that will conduct early phase cancer clinical trials and correlative translational studies. This work will provide the dose, schedule, and early evidence of activity to guide later phase trials, molecularly characterize tumors, and find appropriate biomarkers for better patient selection for drug response to ultimately improve outcomes for cancer patients.

描述（由申请方提供）：早期临床试验的结果是构建II期和III期工作的基石，并在此基础上进行了与药物作用生物学基础相关的科学推断。药物开发的这个新时代--分子靶向治疗的时代--代表了一个范式的转变，即相对于不考虑潜在肿瘤基因组学、生物学和免疫学的“常规”治疗方法，如何考虑早期研究。翻译终点，包括目标表达水平，参与和下游效应物的调节正在尽可能早地进行评估，并且越来越重视早期患者选择，利用新的生物标志物测定和分子表征来识别最有可能应答的患者。NCI实验治疗-临床试验网络（ET-CTN）的最终目的是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，并找到合适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。ET-CTN的目标不能由任何单一的研究者或机构实现，需要具有互补专业知识的协作，多样化和忠诚的成员。为了汇集协助ET-CTN实现其目标所需的协同专业知识，成立了一个综合团队，在这个药物开发的新时代进行临床和转化研究。该团队的目标是：1）对新型抗癌药物和组合进行严格对照的早期临床试验; 2）招募至少12%的服务不足/特殊人群; 3）研究新型药物的临床药理学，药代动力学，药效学和药物基因组学，并在适当的情况下，结合非侵入性成像工具;和4）利用生物标记物测定和先进的分子表征工具来鉴定与治疗反应和抗性相关的分子因素。该团队的成员拥有一套独特的互补专业知识，以及关于合作研究和指导下一代癌症研究人员的类似理念。这种伙伴关系被称为Vanderbilt-Ingram，Karmanos，TGen研究所，耶鲁大学-早期癌症治疗联盟（ViKTriY-ECTC）。这个ViKTriY团队致力于利用他们的专业领域，并最大限度地发挥他们的合作关系，最终使命是改善癌症患者的预后。 相关性：该申请描述了一个多学科团队，将进行早期癌症临床试验和相关的转化研究。这项工作将提供剂量，时间表和活动的早期证据，以指导后期试验，分子表征肿瘤，并找到合适的生物标志物，以更好地选择患者进行药物反应，最终改善癌症患者的预后。