Experimental Therapeutics of Anti-Cancer Agents with Phase I Emphasis

描述（由申请人提供）：该项目包括基础科学家和临床研究人员的多学科团队，致力于为癌症患者寻找有效的新疗法。俄亥俄州州立大学综合癌症中心是一个真正全面的生物医学研究校园，与经验丰富的研究人员，包括来自医学，药学，公共卫生，护理和工程学院的教师密切合作。我们的实验治疗项目的研究人员几十年来一直从事I/II期癌症研究。我们的患者人群支持NCI申办的早期临床试验的稳健累积。每项临床试验都有一个科学家团队参与近实时的药代动力学、药效学和药物基因组学相关研究。我们与其他致力于实验疗法的中心进行了广泛的合作。在确定了新药的安全性和临床特征后，我们的研究人员继续开发战略性联合治疗方案。虽然我们的数据已被用于支持FDA的新药批准，但我们探索假设驱动的治疗试验。我们不仅仅是测试药物。未来的分子靶向治疗，患者肿瘤的基因组分析和相关预测生物标志物的鉴定将在CTEP设计的临床研究中进行探索。除了积极追求新的治疗药物，我们的多学科团队一直致力于教育下一代致力于实验治疗学的翻译科学家。我们的初级教师和博士后学员提供了机会，导致第一阶段的临床试验。我们的主要研究者包括内科肿瘤学家、血液学家、放射肿瘤学家、妇科肿瘤学家和外科肿瘤学家。重点是指导，允许初级研究人员在经验丰富的监督下主持研究。邀请基础科学家加入每个团队，制定意向书，设计临床试验，并参与发展治疗的科学发现。早期临床试验代表了我们改善患者生活的研究使命的长期重点。

DESCRIPTION (provided by applicant): This project encompasses a multi-disciplinary team of basic scientists and clinical investigators dedicated to finding effective new therapies for patiens with cancer. The Ohio State University Comprehensive Cancer Center is a truly comprehensive biomedical research campus with strong collaboration between the experienced investigators including faculty from the respective Colleges of Medicine, Pharmacy, Public Health, Nursing, and Engineering. Investigators in our Experimental Therapeutics Program have been engaged in phase l/ll cancer studies for decades. Our patient population supports robust accrual to NCI-sponsored early clinical trials. Each clinical trial engages a team of scientists with incorporatio of near real-time pharmacokinetics, pharmacodynamics, and pharmacogenomics correlative studies. We have collaborated extensively with other centers dedicated to experimental therapeutics. After defining the safety profile and clinical characteristics of novel agents, our investigators pursue the subsequent development of strategic combination regimens. While our data has been utilized in supporting new drug approvals by the FDA, we explore hypothesis-driven therapeutic trials. We do not simply test drugs. The future of molecular-targeted therapy, genomic profiling of a patient's tumor and the identification of relevant predictive biomarkers wil be explored in clinical studies designed with CTEP. In addition to vigorous pursuit of novel therapeutic agents, our multi-disciplinary team has been heavily engaged in educating the next generation of translational scientists dedicated to experimental therapeutics. Our junior faculty and post-doctoral trainees are provided with the opportunity to lead phase I clinical trials. Our principal investigators include medical oncologists, hematologists, radiation oncologists, gynecologic oncologists, and surgical oncologists. The emphasis is on mentoring allowing the junior investigators to chair the studies under experienced supervision. Basic scientists are invited to join each team in developing the letter of intent, designing the clinical trial, and the engaging in the scientific discovery of developmental therapy. Early clinical trials represent a longstanding emphasis of our research mission to improve patients' lives.