Dana-Farber/Harvard Cancer Center ET-CTN with Phase I Emphasis

丹娜—法伯癌症研究所/哈佛大学癌症中心 ET-CTN，重点为 I 期

基本信息

批准号：
8725826
负责人：
KEITH T FLAHERTY
金额：
$ 140万
依托单位：
DANA-FARBER CANCER INST
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：
2014-03-13 至 2019-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8725826
关键词：
Advanced Malignant Neoplasm Agreement BCL1 Oncogene BRAF gene Biological Assay Biological Markers CDC2 Protein Kinase Cancer Biology Cancer Center Cancer Therapy Evaluation Program Cell Cycle Progression Cells Clinical Clinical Trials Clinical Trials Network Commit Computational Biology Conduct Clinical Trials DNA Damage Dana-Farber Cancer Institute Development Plans Diagnostic Discipline Disease Dose Drug Kinetics Epigenetic Process Evaluation Funding General Hospitals Genomics Histopathology Hospitals Image Immunohistochemistry Institutes Israel Joints K-Series Research Career Programs KRAS2 gene Laboratories Lead Leadership MEK inhibition Malignant Neoplasms Massachusetts Medical center Medicine Memorial Sloan-Kettering Cancer Center Mentors Modeling Molecular Molecular Target Mutation New Agents PARP inhibition Pathology Pathway interactions Patients Performance Pharmaceutical Preparations Pharmacodynamics Pharmacology Phase Public Health Research Research Personnel Resistance Resources Safety Schedule Signal Transduction Site Specimen Therapeutic Therapeutic Clinical Trial Therapy Clinical Trials TimeLine Training Translational Research U-Series Cooperative Agreements University of Texas M D Anderson Cancer Center Woman Work angiogenesis assay development base cancer therapy career development drug development exome immunoregulation improved inhibitor/antagonist member molecular imaging mutant patient population programs response transcriptome sequencing treatment strategy treatment trial tumor working group

项目摘要

DESCRIPTION (provided by applicant): The NCI-designated Dana-Farber/Harvard Cancer Center (DF/HCC).includes the Dana-Farber Cancer Institute (DFCI)/Brigham and Women's Hospital (BWH), Massachusetts General Hospital (MGH) and the Beth Israel Deaconess Medical Center (BIDMC) and functions in overseeing all aspects of clinical trials performed at these sites. The overall objective of this UM1 Cooperative Agreement application from the DF/HCC, which serves as the Lead Academic Organization (LAO), is to provide the clinical and scientific expertise and patient resources to participate in the integrated NCI Experimental Therapeutics-Clinical Trials Network (ET-CTN). The DF/HCC Translational Pharmacology and Early Therapeutic Trials (TPETT) Program has coordinated early phase drug development efforts at DF/HCC with support under an.NCI/CTEP Phase I U01 Agreement in place since 1993. During the current funding period (2/1/2008-present), members of the DF/HCC TPETT Program have participated in the conduct of 48 CTEP-sponsored trials with an overall accrual of 470 patients (85/year). The DF/HCC has also collaborated with other U01 sites, such as MSKCC, MDACC and Karmanos Cancer Institute, in the performance of CTEP trials. The DF/HCC ET-CTN site will consist of a Leadership and Steering Committee that will oversee regulatory, pharmacokinetic, genomic, pathology-based, biostatistical, and career development components. DF/HCC will be committed to the formation of investigational agent-specific trans-network Project Teams with the NCI and other ET-CTN sites to define drug development plans and conduct early phase therapeutic trials of CTEP-sponsored agents. Expertise of the DF/HCC ET-CTN in pharmacokinetics, pharmacodynamics, cancer biology, biomarker assay development, imaging and molecular characterizations will be shared with other sites in team-based approaches. Emphasis will also be placed on mentored training of junior investigators in experimental therapeutics.

描述（由申请人提供）：NCI指定的Dana-Farber/Harvard癌症中心（DF/HCC）包括Dana-Farber癌症研究所（DFCI）/Brigham and Brigham and妇女医院（BWH），马萨诸塞州马萨诸塞州（MGH）（MGH）（MGH）和Beth Israel Deaceess Medical Center（Bidecons Medical Center（BIDMC），这些方面都在这些方面以及这些方面杂乱无章站点。 DF/HCC的这项UM1合作协议应用的总体目标是作为主要学术组织（LAO），是提供临床和科学专业知识和患者资源，以参与NCI综合实验性治疗学 - 临床试验网络（ET-CTN）。 The DF/HCC Translational Pharmacology and Early Therapeutic Trials (TPETT) Program has coordinated early phase drug development efforts at DF/HCC with support under an.NCI/CTEP Phase I U01 Agreement in place since 1993. During the current funding period (2/1/2008-present), members of the DF/HCC TPETT Program have participated in the conduct of 48 CTEP-sponsored trials with an overall accrual of 470名患者（85/年）。 DF/HCC还与其他U01站点（例如MSKCC，MDACC和Karmanos癌症研究所）合作，以进行CTEP试验。 DF/HCC ET-CTN站点将由领导和指导委员会组成，该委员会将监督监管，药代动力学，基因组，基于病理，生物统计学和职业发展组成部分。 DF/HCC将致力于与NCI和其他ET-CTN站点组建研究代理特定的跨网络项目团队，以定义药物开发计划并进行CTEP赞助的药物的早期治疗试验。 DF/HCC ET-CTN在药代动力学，药效学，癌症生物学，生物标志物测定开发，成像和分子特征方面的专业知识将与其他基于团队的方法共享。重点还将放在对实验治疗的初级研究人员的指导培训上。