ViKTriY-PC Consortium Phase II Supplement

ViKTriY-PC 联盟第二阶段补充文件

• 批准号: 9095104
• 负责人: JORDAN D BERLIN
• 金额: $ 73.24万
• 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 2020-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9095104
• 关键词: Area; Award; Back; Basic Science; Biological Assay; Biological Markers; Biology; California; Cancer Center; Cancer Therapy Evaluation Program; Classification; Clinic; Clinical; Clinical Investigator; Clinical Trials; Clinical Trials Network; Data; Development; Discipline; Disease; Eligibility Determination; Evolution; Faculty; Generations; Genomics; Geographic Locations; Goals; Grant; Histologic; Immunology; Immunotherapy; Institution; Investigational Therapies; Knowledge; Leadership; Malignant Neoplasms; Mentors; Mentorship; Mission; Molecular; Monitor; National Cancer Institute; Parents; Patient Selection; Patients; Phase; Phase I/II Trial; Phase II Clinical Trials; Philosophy; Reporting; Research; Research Design; Research Infrastructure; Research Institute; Research Personnel; Resistance; San Francisco; Schedule; Science; Scientist; Selection for Treatments; Serum; Site; Staging; Stratification; Testing; Therapeutic; Therapeutic Clinical Trial; Translational Research; Translations; United States National Institutes of Health; Universities; Variant; Work; base; clinical investigation; design; drug development; imaging biomarker; improved outcome; member; multidisciplinary; next generation; novel; novel anticancer drug; novel marker; oncology; patient population; phase 2 study; public health relevance; student mentoring; tissue biomarkers; tool; translational medicine; tumor

 DESCRIPTION (provided by applicant): The new era in drug development 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. As these endpoints have become more common, the traditional classification of clinical trials as distinct Phase 1 or Phase 2 studies is often insufficient. Rather, these studies have become blended into an "early clinical trial" classification, and a wider range of expertise is necessary to conduct them. 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. While the original ET-CTN UM1 grant had a Phase 1 emphasis, this goal can be better achieved by expanding the scope of activities by merging Phase 2 clinical trials into the Network. This application is a revision to our parent ETCTN UM1 award (1UM1CA186689) with the purpose of describing our capabilities to conduct Phase 2 clinical trials. We have added 2 institutions to our original partnership, and have termed it Vanderbilt-Ingram, Karmanos, TGen Research Institute, Yale - Pacific Coast (University of California-San Diego and University of California-San Francisco) (ViKTriY - PC). As Phase 2 capabilities are added, our team aims to 1) leverage institutional science to develop Phase 2 trials using the CTEP portfolio in rare cancers, common cancers, and uncommon variants of common cancers; 2) incorporate serum, tissue and imaging biomarkers into novel Phase 2 trials to better understand the effects of novel agents either alone or in combination; 3) and develop fellows and junior faculty who are knowledgeable and proficient in conducting early phase clinical trials across the Phase 1 and 2 spectrum, and help them advance promising trials to Phase 3. 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 ViKTriY-PC team is committed to utilizing their areas of expertise and maximizing their collaborative relationships to conduct cutting- edge Phase 1 and 2 trials within the ET-CTN with the ultimate mission of improving outcomes for patients with cancer.

 描述（由申请人提供）：药物开发的新时代代表了相对于“传统”治疗方法如何看待早期研究的范式转变，而不考虑潜在的肿瘤基因组学、生物学和免疫学终点，包括转化终点。下游效应器的靶标表达、参与和调节正在被尽早评估，并且越来越重视早期患者选择，利用新型生物标志物测定和分子表征来识别最有可能对这些终点做出反应的患者。随着临床试验变得越来越普遍，传统的临床试验分类为不同的 1 期或 2 期研究往往是不够的，相反，这些研究已经融入“早期临床试验”分类，并且需要更广泛的专业知识来进行这些研究。 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，利用肿瘤分子特征的能力并找到合适的生物标志物来选择最有可能产生反应的患者。虽然最初的 ET-CTN UM1 资助重点是第一阶段，但通过将第二阶段临床试验合并到网络中来扩大活动范围可以更好地实现这一目标。该应用程序是对我们的母体 ETCTN UM1 的修订。奖项（1UM1CA186689），目的是描述我们进行 2 期临床试验的能力。我们在原来的合作伙伴关系中增加了 2 个机构，并将其命名为 Vanderbilt-Ingram、Karmanos、耶鲁大学 TGen 研究所 - 太平洋海岸（加州大学圣地亚哥分校和加州大学旧金山分校）（ViKTriY - PC）随着第二阶段功能的增加，我们团队的目标是 1) 利用机构科学来开发第二阶段试验。在罕见癌症、常见癌症和罕见癌症中使用 CTEP 产品组合；2) 将血清、成像变异和成像生物标志物纳入新的 2 期试验，以更好地了解新药物单独或组合的效果 3) 并开发；研究员和初级教师，他们知识渊博，精通在 1 期和 2 期范围内进行早期临床试验，并帮助他们将有希望的试验推进到 3 期。该团队的成员拥有一套独特的互补专业知识和类似的合作理念ViKTriY-PC 团队致力于利用他们的专业领域并最大限度地利用他们的合作关系，在 ET-CTN 内进行尖端的 1 期和 2 期试验，最终使命是改进癌症研究人员的研究和指导。患者的结果癌症。