VICKtOrY Early Clinical Trials Consortium

VICKtory 早期临床试验联盟

• 批准号: 10784848
• 负责人: PATRICIA M. LORUSSO
• 金额: $ 204.45万
• 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 2026-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10784848
• 关键词: Acceleration; Amendment; American Indians; Antineoplastic Agents; Area; Award; Back; Biological Assay; Biological Markers; Biology; California; Cancer Center; Cancer Patient; Cancer Therapy Evaluation Program; Catchment Area; Clinic; Clinical; Clinical Investigator; Clinical Research; Clinical Trials Network; Collaborations; Data; Development; Discipline; Disease; Drug Delivery Systems; Drug Kinetics; Early Therapeutic-Clinical Trials Network; Education; Eligibility Determination; Evolution; Faculty; Funding; Generations; Genomics; Geography; Goals; Health Service Area; Histologic; Immunology; Immunotherapy; Infrastructure; Institution; Investigation; Investigational Therapies; Knowledge; Laboratories; Leadership; Letters; Malignant Neoplasms; Mentors; Mentorship; Methods; Minority Groups; Mission; Molecular; Monitor; National Cancer Institute; Oklahoma; Oncology; Patient Recruitments; Patient Selection; Patient-Focused Outcomes; Patients; Pharmacodynamics; Pharmacopoeias; Phase; Philosophy; Population; Protocols documentation; Reporting; Research; Research Design; Research Personnel; Resistance; Rural Population; Science; Serum; Services; Site; Special Population; Stratification; Testing; Therapeutic; Toxic effect; Training; Translating; Translational Research; Translations; Universities; Variant; Work; Yale Cancer Center; bench to bedside; biomarker driven; cancer clinical trial; career; clinical investigation; clinical trial recruitment; design; drug development; early phase clinical trial; early phase trial; experience; imaging biomarker; improved outcome; member; multidisciplinary; next generation; novel; novel anticancer drug; novel marker; novel therapeutic intervention; novel therapeutics; patient biomarkers; patient population; patient subsets; phase II trial; rare cancer; recruit; resistance mechanism; response; rural Americans; skills; student mentoring; tissue biomarkers; tool; translational medicine; treatment optimization; trial design; tumor

The new era in cancer drug development represents a paradigm shift in how early phase studies are conducted 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 (ETCTN) is to develop new therapeutic options while also defining better approaches for the development of novel anticancer agents that capitalize on the ability to characterize tumors molecularly and by also finding appropriate biomarkers to select patients most likely to respond. As biomarker-driven trials become the cornerstone of early phase investigation, allowing for the study of potential mechanisms of response and resistance, incorporation of these biomarkers is lending itself to novel trial designs which incorporate fewer, and often rarer patient subsets, defining greater patient outcomes with smaller recruited populations. As a result, a unique network such as the ETCTN, consisting of multiple scientifically-driven sites and investigators with a vast array of expertise, is needed. The ETCTN allows investigators to test relevant bench-to-bedside findings, and through integrated analysis and the development of interdisciplinary teams, incorporates reverse translation to bring the bedside back to the bench. This application is a re-competition of our previous ETCTN UM1 award (1UM1CA186689), demonstrating both our progress over the past funding period as well as our capabilities to conduct early phase clinical trials. We have slightly amended our original partnerships which now include Vanderbilt-Ingram, University of California San Diego, Karmanos Cancer Institute, University of Oklahoma Stephenson Cancer Center (new) and the Yale Cancer Center (VICKtOrY). Our team aims to 1) leverage novel scientific discoveries for translation into early phase trials, using the CTEP pharmacopeia, in rare cancers, common cancers, and uncommon variants of common cancers; 2) incorporate serum, tissue and imaging biomarkers to better understand the effects of novel agents either alone or in combination; 3) train early career investigators to be knowledgeable and proficient in conducting early phase clinical trials by providing clinical research leadership opportunities and mentoring; and 4) include as a component of our early phase clinical trial recruitment, no less than 10% underserved/special populations. The members of our team have a unique set of complementary expertise and a similar philosophy regarding collaborative research and mentorship of the next generation of cancer investigators. VICKtOrY is committed to utilizing our areas of expertise, integrating the science at our institutions, and maximizing our collaborative relationships to conduct cutting-edge early phase trials within the ETCTN with the ultimate mission of improving outcomes for cancer patients.

癌症药物开发的新时代代表了早期研究如何进行的范式转变 相对于不考虑潜在肿瘤基因组学、生物学的“传统”治疗方法 和免疫学终点，包括靶标表达、参与和调节的水平。 正在尽早评估下游影响，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重要的患者 NCI 实验治疗临床试验网络 (ETCTN) 的最终目的。 是开发新的治疗选择，同时定义更好的方法来开发新的药物 利用分子表征肿瘤的能力并通过寻找合适的抗癌药物 随着生物标志物驱动的试验成为早期的基石，以选择最有可能做出反应的患者。 阶段研究，允许研究潜在的反应和抵抗机制，合并 这些生物标志物有助于新颖的试验设计，其中纳入的患者数量更少，而且往往更稀有 子集，以更少的招募人群定义更好的患者结果，从而形成一个独特的网络。 例如 ETTCTN，由多个科学驱动的站点和拥有大量知识的研究人员组成 ETCTN 允许研究人员测试相关的临床结果，并通过 综合分析和跨学科团队的发展，结合逆向翻译，带来 床边回到替补席 此申请是我们之前的 ETCTN UM1 奖项的重新竞争。 (1UM1CA186689)，展示了我们在过去的资助期内取得的进展以及我们的能力 我们稍微修改了我们原来的合作伙伴关系，现在包括。 范德比尔特-英格拉姆、加州大学圣地亚哥分校、卡马诺斯癌症研究所、俄克拉荷马大学 史蒂芬森癌症中心（新）和耶鲁癌症中心 (VICKtOrY) 我们的团队旨在利用新颖的优势。 使用 CTEP 药典将科学发现转化为罕见癌症的早期试验， 常见癌症以及常见癌症的罕见变体；2) 结合血清、组织和影像学 生物标志物，以更好地了解新药物单独或联合使用的效果 3) 培训早期职业； 研究人员通过提供临床知识和能力来进行早期临床试验 研究领导机会和指导；4) 包括作为我们早期临床试验的一部分 招聘中，不少于 10% 的服务不足/特殊人群 我们团队的成员拥有独特的组合。 互补的专业知识和关于合作研究和指导的类似理念 VICKtOrY 致力于利用我们的专业领域，整合下一代癌症研究人员。 我们机构的科学，并最大化我们的合作，以尽早开展尖端研究 ETCTN 内的阶段试验的最终使命是改善癌症患者的治疗结果。

项目成果

Multicenter Phase II Trial of the PARP Inhibitor Olaparib in Recurrent IDH1- and IDH2-mutant Glioma.

PARP 抑制剂奥拉帕尼治疗复发性 IDH1 和 IDH2 突变胶质瘤的多中心 II 期试验。

• 发表时间: 2023-02
• 作者: Fanucci, Kristina;Pilat, Mary Jo;Shyr, Derek;Shyr, Yu;Boerner, Scott;Li, Jing;Durecki, Diane;Drappatz, Jan;Puduvalli, Vinay;Lieberman, Frank Scott;Gonzalez, Javier;Giglio, Pierre;Ivy, S Percy;Bindra, Ranjit S;Omuro, Antonio;LoRusso, Patrici
• 通讯作者: LoRusso, Patrici

Correction to: Phase I study combining the aurora kinase a inhibitor alisertib with mFOLFOX in gastrointestinal cancer.

更正：将极光激酶 a 抑制剂 alisertib 与 mFOLFOX 联合治疗胃肠道癌症的 I 期研究。

• 发表时间: 2018
• 影响因子: 3.4
• 作者: Goff, Laura W;Azad, Nilofer S;Stein, Stacey;Whisenant, Jennifer G;Koyama, Tatsuki;Vaishampayan, Ulka;Hochster, Howard;Connolly, Roisin;Weise, Amy;LoRusso, Patricia M;Salaria, Safia N;El;Berlin, Jordan D
• 通讯作者: Berlin, Jordan D

Inhibition of the PI3K/AKT/mTOR Pathway in Solid Tumors.

• DOI: 10.1200/jco.2014.59.0018
• 发表时间: 2016-09-30
• 期刊: Journal of clinical oncology : official journal of the American Society of Clinical Oncology
• 作者: P. LoRusso

Circulating Tumor DNA Dynamics Fail to Predict Efficacy of Poly(ADP-ribose) Polymerase/VEGFR Inhibition in Patients With Heavily Pretreated Advanced Solid Tumors.

循环肿瘤 DNA 动力学无法预测聚（ADP-核糖）聚合酶/VEGFR 抑制对经过大量预处理的晚期实体瘤患者的疗效。

• 发表时间: 2024-02
• 影响因子: 4.6
• 作者: Hu, Yiduo;Narayan, Azeet;Xu, Yunshan;Wolfe, Julia;Vu, Dennis;Trinh, Thi;Kantak, Chaitanya;Ivy, S Percy;Eder, Joseph Paul;Deng, Yanhong;LoRusso, Patricia;Kim, Joseph W;Patel, Abhijit A
• 通讯作者: Patel, Abhijit A

Clinical Activity and Safety of Cediranib and Olaparib Combination in Patients with Metastatic Pancreatic Ductal Adenocarcinoma without BRCA Mutation.

西地尼布和奥拉帕尼联合治疗无 BRCA 突变的转移性胰管腺癌患者的临床活性和安全性。

• 发表时间: 2021
• 作者: Kim, Joseph W;Cardin, Dana B;Vaishampayan, Ulka N;Kato, Shumei;Grossman, Steven R;Glazer, Peter M;Shyr, Yu;Ivy, S Percy;LoRusso, Patricia M
• 通讯作者: LoRusso, Patricia M