Experimental Therapeutics of Anti-Cancer Agents with Phase I Emphasis

以 I 期为重点的抗癌药物实验治疗

基本信息

批准号：
9027805
负责人：
ROBERT S. DIPAOLA
金额：
$ 95.71万
依托单位：
OHIO STATE UNIVERSITY
依托单位国家：
美国
项目类别：
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/9027805
关键词：
Antineoplastic Agents Basic Science Biological Assay Biomedical Research Blood Cancer Patient Cancer Therapy Evaluation Program Characteristics Clinical Clinical Investigator Clinical Research Clinical Trials Clinical Trials Design Clinical Trials Network Collaborations Comprehensive Cancer Center Correlative Study Data Development Developmental Therapeutics Program Disease Disease Progression Dose Drug Administration Schedule Drug Kinetics Effectiveness Eligibility Determination Engineering Evaluation Exposure to Faculty Functional Imaging Functional disorder Future Goals Gynecologic Oncologist Hematologic Neoplasms Hematologist Hepatic Image Analysis Individual Investigation Investigational Drugs Investigational Therapies Joints Kidney Knowledge Laboratories Laboratory Study Lead Letters Malignant Neoplasms Medical Oncologist Medicine Mentors Minority Mission Molecular Target National Cancer Institute National Clinical Trials Network New Agents New Drug Approvals Ohio Outcome Patients Pharmaceutical Preparations Pharmacodynamics Pharmacogenomics Pharmacy facility Phase Phase I Clinical Trials Physicians Population Postdoctoral Fellow Principal Investigator Protocols documentation Public Health Nurses Public Health Nursing Radiation Oncologist Recommendation Regimen Relapse Research Research Design Research Personnel Research Project Grants Resistance Safety Schedule Scheme Science Scientist Signal Pathway Solid Neoplasm Specimen Supervision Surgical Oncologist Testing Therapeutic Therapeutic Agents Therapeutic Trials Time Toxic effect Universities Variant base career development clinical effect college design drug testing experience genomic profiles improved molecular targeted therapies named group next generation novel novel anticancer drug novel therapeutics patient population patient safety phase I trial predictive marker programs response safety testing standard care tumor

项目摘要

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. RELEVANCE: This research project will identify new treatments for cancer patients. New agents that appear to be promising in the laboratory studies are introduced to cancer patients whose options are limited with standard treatment. In giving these new agents to cancer patients, the physicians observe the effects on the condition of the patient. Patients have blood drawn to test the safety and the effectiveness of these new treatments. If an agent is promising, further studies will be planned based on this information.

描述（由申请人提供）：该项目由基础科学家和临床研究人员组成的多学科团队组成，致力于为癌症患者寻找有效的新疗法。俄亥俄州立大学综合癌症中心是一个真正综合性的生物医学研究园区，经验丰富的研究人员（包括来自医学院、药学院、公共卫生学院、护理学院和工程学院的教员）之间开展了强有力的合作。我们实验治疗项目的研究人员几十年来一直从事 l/ll 期癌症研究。我们的患者群体支持 NCI 资助的早期临床试验的强劲增长。每个临床试验都由一组科学家参与，并结合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治疗的中心进行了广泛的合作。在确定新药的安全性和临床特征后，我们的研究人员将继续开发战略性联合治疗方案。虽然我们的数据已用于支持 FDA 批准新药，但我们仍在探索假设驱动的治疗试验。我们不只是测试药物。通过 CTEP 设计的临床研究将探索分子靶向治疗、患者肿瘤基因组分析以及相关预测生物标志物鉴定的未来。除了积极追求新型治疗药物外，我们的多学科团队还大力致力于培养致力于实验治疗学的下一代转化科学家。我们的初级教师和博士后实习生有机会领导一期临床试验。我们的主要研究人员包括肿瘤内科医生、血液科医生、放射肿瘤科医生、妇科肿瘤科医生和外科肿瘤科医生。重点是指导，让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各个团队，制定意向书、设计临床试验，并参与发育治疗的科学发现。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。相关性：该研究项目将为癌症患者确定新的治疗方法。在实验室研究中似乎有希望的新药物被引入到标准治疗选择有限的癌症患者中。在向癌症患者提供这些新药物时，医生会观察其对患者病情的影响。抽血来测试这些新疗法的安全性和有效性。如果一种药物有希望，将根据这些信息计划进一步的研究。