权益分类	功能权益	普通用户	{{item.name}}会员
{{category.name}}	{{benefitItem.name}}

Phase 2 Clinical Trials Program for Experimental Therapeutics Clinical Trials Network

实验疗法临床试验网络二期临床试验计划

基本信息

批准号：
9094959
负责人：
ALEX A. ADJEI
金额：
$ 91.25万
依托单位：
MAYO CLINIC ROCHESTER
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：
2014-04-07 至 2020-02-29
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9094959
关键词：
Adoption African American Angiography Antineoplastic Agents Biological Biological Markers Biopsy Blood flow Brain Neoplasms CLIA certified Cancer Biology Cancer Center Cancer Patient Clinic Clinical Clinical Trials Clinical Trials Network Combined Modality Therapy Communities Comprehensive Cancer Center Dendritic Cells Diagnosis Doppler Ultrasonography Drug Kinetics Effectiveness Eligibility Determination Enrollment Future Genomics Goals Grant Herbert Irving Comprehensive Cancer Center Hispanic Americans Holden Comprehensive Cancer Center at the University of Iowa Image Investigational Therapies Iowa Laboratories Laboratory Study Lymphoma Malignant Neoplasms Maryland Mayo Clinic Cancer Center Measures Metabolic Mind Modality Molecular Profiling Molecular Target National Cancer Institute New Agents Normal tissue morphology Oncolytic viruses Outcome Ovary Pancreas Parents Pathology Pathway interactions Patients Peer Review Peptides Performance Peripheral Blood Mononuclear Cell Pharmacogenetics Phase Phase II Clinical Trials Phase III Clinical Trials Physiologic pulse Population Positron-Emission Tomography Protocols documentation Reaction Time Recording of previous events Research Safety Science Site Specialized Program of Research Excellence TNFRSF5 gene Testing Therapeutic Therapeutic Clinical Trial Time Toxic effect Translating Translational Research Tumor Tissue Universities Work cancer therapy cancer type design drug development experience malignant breast neoplasm member novel novel anticancer drug patient population patient safety phase 1 study phase 2 study potential biomarker pre-clinical programs public health relevance small molecule success targeted agent therapeutic evaluation tumor

项目摘要

DESCRIPTION (provided by applicant): This proposed UM1 phase 2 supplement brings together teams from NCI-designated comprehensive cancer centers at Mayo Clinic, University of Maryland, Columbia University, and the University of Iowa to collectively perform early phase clinical trials. Members of this proposed ETCTN team have accrued 3939 patients to phase 2 clinical trials from 2010 through 2014, demonstrated expertise in translational science, and established specialized facilities to develop biomarkers for clinical trials, including the Mayo Clinic Pathology Research Core and CLIA-certified University of Maryland Translational Genomic Laboratory. We now propose to conduct phase 2 clinical trials of NCI-sponsored anti-cancer agents to evaluate the clinical activity and biological impact of these agents on their molecular targets, elucidate other relevant biologic effects, and determine the correlation between clinical outcomes and relevant biomarkers and/or imaging endpoints. The goal of these studies is to not only determine, as efficiently as is compatible with patient safety, the effectiveness of new anticancer agents selected by the NCI or promising combination therapies and high- priority agents that are pivotal for drug development, but also facilitate the correlativ science needed to understand and properly develop these agents. The intent is to seamlessly move studies from phase 1 into phase 2 and to bring forward therapeutic approaches that can be incorporated into phase 3 clinical trials sponsored by other mechanisms. Studies will be designed using clinical endpoints that are appropriate for the therapeutic mechanism of the specific agent under study such as response, time to progression, progression- free rate at a point in time or survival. Importantly, alternative or secondary endpoints for the studies to be performed under this supplement may include changes in biomarker endpoints or imaging endpoints, including changes in blood flow and/or alterations in tumor metabolic activity. Accordingly, the specific aims of this proposal are to: i) determine the clinical activity, efficac and safety of novel anticancer agents and combinations selected by NCI for evaluation of therapeutic activity across a range of malignancies, whether chosen by histological subtype or molecular profile; ii) efficiently and seamlessly take promising therapies from phase 1 into phase 2 trials; iii) evaluate translational endpoints such as levels of expression and/or activity of molecular targets and/or downstream effectors pertinent to a given agent or pathway modulated by the agent under study; iv) identify and test potential biomarkers (with particular emphasis where possible on genomics and imaging) that may serve as predictors of efficacy or toxicity; and v) translate preclinical science and new discoveries from R01, SPORE or other peer reviewed mechanisms into clinical trials that leverage the expertise of the scientific community using a team science approach.