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 指定的丹娜—法伯癌症中心 (DF/HCC)。包括丹娜—法伯癌症研究所 (DFCI)/布莱根妇女医院 (BWH)、麻省总医院 (MGH) 和贝斯以色列女执事医疗中心 (BIDMC) 负责监督在这些地点进行的临床试验的各个方面。作为牵头学术组织 (LAO) 的 DF/HCC 提出的 UM1 合作协议申请的总体目标是提供临床和科学专业知识以及患者资源，以参与综合 NCI 实验治疗-临床试验网络 ( ET-CTN）。 DF/HCC 转化药理学和早期治疗试验 (TPETT) 计划在 1993 年以来实施的 NCI/CTEP I 期 U01 协议的支持下协调了 DF/HCC 的早期药物开发工作。在当前资助期间（2/ 1/2008 年至今），DF/HCC TPETT 计划的成员参与了 48 项 CTEP 资助的试验，总体累积了470 名患者（85 名/年）。 DF/HCC 还与其他 U01 中心（例如 MSKCC、MDACC 和 Karmanos 癌症研究所）合作进行 CTEP 试验。 DF/HCC ET-CTN 站点将由一个领导和指导委员会组成，负责监督监管、药代动力学、基因组、病理学、生物统计和职业发展等组成部分。 DF/HCC 将致力于与 NCI 和其他 ET-CTN 站点组建研究药物特异性跨网络项目团队，以制定药物开发计划并开展 CTEP 赞助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、成像和分子表征方面的专业知识将与基于团队的方法中的其他站点共享。还将强调对实验治疗学初级研究人员的指导培训。