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Phase I Trials of Anti-Cancer Agents

抗癌药物的一期试验

基本信息

批准号：
7914670
负责人：
MICHAEL R GREVER
金额：
$ 33.15万
依托单位：
OHIO STATE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-09-01 至 2013-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7914670
关键词：
Antineoplastic Agents Apoptosis Basic Science Biological Assay Biological Sciences Biomedical Research Cancer Center Cancer Patient Cancer Therapy Evaluation Program Cell Cycle Regulation Cell Survival Childhood Clinic Clinical Clinical Research Clinical Trials Clinical assessments Comprehensive Cancer Center Conduct Clinical Trials Correlative Study Data Dentistry Development Disease Dose Drug Administration Schedule Drug Kinetics Engineering Evaluation Exposure to Faculty Functional Imaging Functional disorder Goals Hepatic Histones Human Individual Intention Interdisciplinary Study Investigation Investigational Drugs Investigational Therapies Joints Kidney Knowledge Laboratories Laboratory Study Malignant - descriptor Malignant Neoplasms Measurement Medicine Methylation Mission Molecular Molecular Genetics Molecular Target Monoclonal Antibodies National Cancer Institute New Agents Nurses Ohio Outcome Patients Pharmaceutical Preparations Pharmacodynamics Pharmacogenomics Pharmacy facility Phase Phase I Clinical Trials Play Population Post-Translational Protein Processing Process Protocols documentation Public Health Recommendation Regulation Research Design Research Personnel Role Safety Schedule Scheme Scientist Signal Pathway Signal Transduction Pathway Therapeutic Therapeutic Agents Therapeutic Human Experimentation Time Toxic effect Treatment Protocols Universities Variant Veterinary Medicine angiogenesis base cancer therapy clinical effect college critical period design experience man named group neoplastic cell novel novel therapeutics patient safety physical science pre-clinical programs response therapeutic target tumor

项目摘要

DESCRIPTION (provided by applicant): Phase I studies play a critical role in the development of new cancer therapies. These trials are the initial interface between basic and clinical research for "first in human" studies. Successful therapeutic research embodies an iterative process between the clinic and the laboratory during this critical period of initial development. Whereas in the past, phase I trials focused strictly upon defining the toxicity and pharmacokinetics of new agents, the current emphasis requires that more information is efficiently procured without compromising the analysis of safe and effective administration. This mandate requires real-time procurement of pharmacokinetics, pharmacodynamics, and pharmacogenomics as well as meticulous clinical assessment. In this application, both clinical and basic science investigators of The Ohio State University Comprehensive Cancer Center (OSUCCC) join in a collaborative approach to conduct phase I trials of new cancer therapeutic agents and regimens. Investigators will cooperate closely with the National Cancer Institute in developing correlative studies to evaluate clinical outcomes in the context of basic science observations. The present application builds upon approximately 30 years of experience and the scientific strength of the OSUCCC in conducting clinical trials with pertinent biologic measurements. Trials will target agents and strategies with which our faculty has prior preclinical experience and/or cellular and molecular networks under study in their laboratories. The Experimental Therapeutics Program at OSUCCC has expertise in signal transduction pathways, angiogenesis, cell cycle control, selective induction of tumor cell apoptosis, monoclonal antibodies, molecular genetics, histone protein modification, DMA methylation and other basic targeted therapeutic strategies. The Ohio State University represents one of the most comprehensive biomedical research campuses in the world dedicated to interdisciplinary research. Respective scientists associated with experimental therapy of cancer form a critical mass within the Colleges of Medicine and Public Health, Pharmacy, Biological Sciences, Mathematical and Physical Sciences, Veterinary Medicine, Engineering, Dentistry, and Nursing. This is a Phase I clinical trials program designed to achieve the ultimate goals of expedient (yet thorough) dose-finding trials in man with the intention of providing safe and effective new therapy to benefit patients with malignant diseases.

描述（由申请人提供）：I期研究在开发新的癌症疗法中发挥关键作用。这些试验是基础研究和临床研究之间的初始接口，用于“首次人体”研究。成功的治疗性研究体现了临床和实验室之间的迭代过程，在这一关键时期的初步发展。而在过去，I期试验严格集中在定义新药物的毒性和药代动力学，目前的重点是需要更多的信息，有效地采购，而不影响安全和有效的管理分析。这项任务要求实时采购药代动力学、药效学和药物基因组学以及细致的临床评估。在这项申请中，俄亥俄州州立大学综合癌症中心（OSUCCC）的临床和基础科学研究人员共同合作，进行新癌症治疗药物和方案的I期试验。研究人员将与国家癌症研究所密切合作，开展相关研究，以在基础科学观察的背景下评估临床结局。本申请建立在OSUCCC在利用相关生物测量进行临床试验方面的约30年经验和科学实力的基础上。试验将针对药物和策略，我们的教师在他们的实验室中研究之前的临床前经验和/或细胞和分子网络。OSUCCC的实验治疗项目在信号转导途径，血管生成，细胞周期控制，选择性诱导肿瘤细胞凋亡，单克隆抗体，分子遗传学，组蛋白修饰，DMA甲基化和其他基本靶向治疗策略方面具有专长。俄亥俄州州立大学是世界上最全面的生物医学研究校园之一，致力于跨学科研究。与癌症的实验治疗相关的各个科学家在医学和公共卫生，药学，生物科学，数学和物理科学，兽医，工程，牙科和护理学院内形成了临界质量。这是一项I期临床试验项目，旨在实现在人体中进行的权宜（但彻底）剂量探索试验的最终目标，旨在提供安全有效的新疗法，使恶性疾病患者受益。