UM1 Supplement for Early Therapeutic Trials with Phase 2 Intent

UM1 补充用于具有 2 期目的的早期治疗试验

• 批准号: 9095812
• 负责人: MICHAEL R GREVER
• 金额: $ 86.13万
• 依托单位: OHIO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-03-28 至 2020-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9095812
• 关键词: Antineoplastic Agents; Appalachian Region; Biological Response Modifier Therapy; Blood; Bone Marrow Neoplasms; Cancer Burden; Cancer Center; Cancer Patient; Clinic; Clinical; Clinical Trials; Clinics and Hospitals; Comprehensive Cancer Center; Data; Data Collection; Development; Dose; Drug Kinetics; Evaluation; Generations; Goals; Grant; Hematologic Neoplasms; Image; Incidence; Institutes; Institution; Kentucky; Laboratory Research; Malignant Neoplasms; Maximum Tolerated Dose; Medical center; Metabolism; Modality; Molecular Target; National Cancer Institute; New Agents; Normal tissue morphology; Ohio; Outcome; Parents; Patients; Pharmaceutical Preparations; Pharmacodynamics; Pharmacy Schools; Phase; Phase II Clinical Trials; Population; Publications; Reporting; Research; Research Infrastructure; Resistance; Resources; Safety; Solid Neoplasm; Structure; Technology; Therapeutic; Therapeutic Agents; Therapeutic Trials; Tissues; Toxic effect; Translational Research; Underserved Population; Universities; University Hospitals; West Virginia; anticancer research; anticancer treatment; antitumor effect; base; cancer therapy; disadvantaged population; imaging modality; insight; member; mortality; named group; novel; novel anticancer drug; novel therapeutics; peer; predicting response; programs; public health relevance; therapeutic evaluation; treatment center

 DESCRIPTION (provided by applicant): The overall goal of this proposal is to provide a resource to the OSU UM1 (P.I. Michael Grever) for the conduct of Phase 2 clinical trials of National Cancer Institute (NCI) sponsored agents, to evaluate biologic effects of these agents on their molecular targets, to evaluate other relevant biologic effects, and to determine clinical relevant outcomes/correlates of efficacy and toxicity. The Ohio State University NCI-designated Comprehensive Cancer Center (OSUCCC) and its affiliated hospitals and clinics generate a resource of more than 5600 new analytic cancer patients per year. For this supplement proposal, the OSUCCC is partnering with other large cancer research and treatment centers in the State of Ohio: Seidman Cancer Center of University Hospitals Case Medical Center and The Cleveland Clinic Taussig Cancer Institute, consortium members of the NCI-designated Case Comprehensive Cancer Center at Case Western Reserve University (another 10,000 analytic new cancer patients per year) and the newly NCI-designated Markey Cancer Center (MCC) at the University of Kentucky (UK). With the latter institution that provides geographical proximity, we can now provide patients the opportunity for Phase 2 trials in a contiguous region (Ohio-Kentucky-West Virginia corridor) with access to novel therapeutics. It importantly incorporates a heavily underserved and special population (patients from the Central Appalachian Region) to the biological and therapeutic evaluation of novel targets. Access to a top rated school of pharmacy at UK, now strengthens further our translational science expertise.

 描述（由申请人提供）：本提案的总体目标是为 OSU UM1（P.I. Michael Grever）提供资源，以进行国家癌症研究所 (NCI) 资助的药物的 2 期临床试验，评估这些药物对其分子靶点的生物效应，评估其他相关的生物效应，并确定临床相关结果/疗效和毒性的相关性。俄亥俄州立大学 NCI 指定的综合癌症中心 (OSUCCC) 及其附属医院和诊所每年产生超过 5600 名新分析癌症患者的资源。对于此补充提案，OSUCCC 正在与俄亥俄州其他大型癌症研究和治疗中心合作：大学医院凯斯医疗中心的 Seidman 癌症中心和克利夫兰诊所 Taussig 癌症研究所、NCI 指定的凯斯西储大学凯斯综合癌症中心的联盟成员（每年另外分析 10,000 名新癌症患者）以及新近被 NCI 指定的俄亥俄大学马基癌症中心 (MCC)。 肯塔基州（英国）。凭借后一个机构提供的地理邻近性，我们现在可以为患者提供在邻近地区（俄亥俄州-肯塔基州-西弗吉尼亚州走廊）进行 2 期试验的机会，并获得新的治疗方法。重要的是，它将服务严重不足的特殊人群（来自阿巴拉契亚中部地区的患者）纳入新目标的生物学和治疗评估。进入英国顶级药学院，现在进一步加强了我们的转化科学专业知识。