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（由申请人提供）：早期临床试验的结果是建立第2阶段和第3阶段努力的基石，并估算了与药物作用的生物学基础有关的科学推断。这个新时代在药物发育中 - 分子靶向治疗的时代 - 代表者 - 早期研究的范式转变相对于不考虑潜在的肿瘤基因组学，生物学和免疫学的“常规”治疗方法的方法。转化终点，包括目标表达水平，参与度和下游效应子的调节水平正在尽早评估，并且使用新颖的生物标志物测定法和分子表征将重点放在早期患者选择上，以识别最有可能反应的患者。 NCI实验性治疗学 - 临床试验网络（ET-CTN）的最终目的是为开发新型抗癌药的开发定义更好的方法，这些方法利用了分子表征肿瘤的能力，并找到适当的生物标志物，以选择最有可能响应特定药物的患者。 ET-CTN的目标无法由任何单一的调查员或机构实现，并且需要具有互补专业知识的合作，多样化和忠实的成员。为了组装帮助ET-CTN实现目标所需的协同专业知识，在这个新的药物开发时代，已经成立了一个全面的团队来进行临床和转化研究。该团队的目标是1）对新型抗癌剂和组合进行精心控制的早期临床试验； 2）招募至少12％服务/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了非侵入性成像工具； 4）利用生物标志物分析和高级分子表征工具来识别与治疗反应和抗性相关的分子因素。该团队的成员具有一系列独特的补充专业知识，以及关于下一代癌症研究人员的合作研究和指导的类似理念。该合作伙伴关系被称为范德比尔特·洛格拉姆（Vanderbilt -lngram），卡尔马诺斯（Karmanos），耶鲁大学（Tgen Research Institute），耶鲁大学 - 早期的癌症治疗公司（Viktriy -ECTC）。这支维克特里团队致力于利用其专业知识领域，并最大程度地提高其协作关系，以改善癌症患者结局的最终任务。 相关性：该应用描述了一个多学科团队，该团队将进行早期癌症临床试验和相关翻译研究。这项工作将提供活动的剂量，时间表和早期证据，以指导后期试验，分子表征肿瘤，并找到适当的生物标志物，以更好地选择患者，以最终改善癌症患者的结果。