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:
  • 金额:
    $ 91.25万
  • 依托单位:
  • 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

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.
 描述(由适用提供):该拟议的UM1第2阶段补充剂汇集了NCI指定的综合癌症中心的团队,马里兰州大学,哥伦比亚大学和爱荷华大学共同执行早期临床试验。该拟议的ETCTN团队的成员从2010年至2014年开始累积3939名患者到2期临床试验,在转化科学方面具有专业知识,并建立了专门的设施,以开发用于临床试验的生物标志物,包括Mayo Clinic Patherology Research Core和Clia认证的Maryland Maryland University Maryland Translatitation Intrymic translatitation Intrationational Intrantication transicalitation。现在,我们建议对NCI赞助的抗癌药进行2阶段的临床试验,以评估这些药物对它们的分子靶标的临床活性和生物学影响,阐明其他相关的生物学效应,并确定临床结果与相关的生物标志物和/或或成像端点之间的相关性。这些研究的目的不仅是有效地确定与患者的安全兼容,还要确定由NCI或Promise组合疗法选择的新抗癌药物和对药物开发至关重要的高优先型药物的有效性,而且还促进了所需的相关科学需要了解并适当地发展这些药物。目的是将研究从1阶段将研究无缝地转移到第2阶段,并提出可以将治疗方法纳入其他机制赞助的第3阶段临床试验中。研究将使用适合于研究的特定药物的治疗机制的临床终点进行设计,例如响应,进展时间,在某个时间点或生存期间进行自由率。重要的是,在此补充剂下进行研究的替代或次要终点可能包括生物标志物终点或成像终点的变化,包括血液流动的变化和/或肿瘤代谢活性的改变。彼此之间,该提案的具体目的是:i)确定新型抗癌剂的临床活性,有效和安全性以及NCI选择的组合用于评估一系列恶性肿瘤的治疗活性,无论是通过组织学亚型选择还是分子谱选择; ii)有效并无缝将诺言疗法从1阶段进行到第2阶段试验中; iii)评估翻译终点,例如分子靶标的表达水平和/或活性,以及​​/或与所研究药物调节的给定试剂或途径有关的下游效应; iv)可以识别和测试潜在的生物标志物(在可能的情况下特别强调了基因组学和成像),可以作为有效性或毒性的预测指标; v)将R01,孢子或其他同行评审机制的临床前科学和新发现转化为临床试验,以使用团队科学方法来利用科学界的专业知识。

项目成果

期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)

暂无数据

数据更新时间:2024-06-01

ALEX A. ADJEI的其他基金

Clinical evaluation of combination oncolytic viro-immunotherapy for solid tumors
溶瘤病毒免疫联合疗法治疗实体瘤的临床评价
  • 批准号:
    9815079
    9815079
  • 财政年份:
    2018
  • 资助金额:
    $ 91.25万
    $ 91.25万
  • 项目类别:
Network Lead Academic Participating Site Grant from the Roswell Cancer Inst.
罗斯威尔癌症研究所的网络领导学术参与站点资助。
  • 批准号:
    8846079
    8846079
  • 财政年份:
    2014
  • 资助金额:
    $ 91.25万
    $ 91.25万
  • 项目类别:
NCI Experimental Therapeutics-Clinical Trials Network with Phase 1 Emphasis
NCI 实验治疗-临床试验网络,重点为 1 期
  • 批准号:
    9086290
    9086290
  • 财政年份:
    2014
  • 资助金额:
    $ 91.25万
    $ 91.25万
  • 项目类别:
Data & Safety Monitoring
数据
  • 批准号:
    7714444
    7714444
  • 财政年份:
    2008
  • 资助金额:
    $ 91.25万
    $ 91.25万
  • 项目类别:
Protocol-Specific Research Support
特定于协议的研究支持
  • 批准号:
    7714441
    7714441
  • 财政年份:
    2008
  • 资助金额:
    $ 91.25万
    $ 91.25万
  • 项目类别:
Protocol Review & Monitoring
方案审查
  • 批准号:
    7714440
    7714440
  • 财政年份:
    2008
  • 资助金额:
    $ 91.25万
    $ 91.25万
  • 项目类别:
Clinical Research Services
临床研究服务
  • 批准号:
    7714435
    7714435
  • 财政年份:
    2008
  • 资助金额:
    $ 91.25万
    $ 91.25万
  • 项目类别:
Protocol Review and Monitoring System
方案审查和监控系统
  • 批准号:
    7432964
    7432964
  • 财政年份:
    2007
  • 资助金额:
    $ 91.25万
    $ 91.25万
  • 项目类别:
Protocol Specific Research
协议特定研究
  • 批准号:
    7432966
    7432966
  • 财政年份:
    2007
  • 资助金额:
    $ 91.25万
    $ 91.25万
  • 项目类别:
Data and Safety Monitoring
数据和安全监控
  • 批准号:
    7432961
    7432961
  • 财政年份:
    2007
  • 资助金额:
    $ 91.25万
    $ 91.25万
  • 项目类别:

相似海外基金

Enhancing patient and organizational readiness for cardiovascular risk reduction among ethnic minority patients living with HIV
加强患者和组织为降低少数族裔艾滋病毒感染者的心血管风险做好准备
  • 批准号:
    9762974
    9762974
  • 财政年份:
    2018
  • 资助金额:
    $ 91.25万
    $ 91.25万
  • 项目类别:
Enhancing patient and organizational readiness for cardiovascular risk reduction among ethnic minority patients living with HIV
加强患者和组织为降低少数族裔艾滋病毒感染者的心血管风险做好准备
  • 批准号:
    10424753
    10424753
  • 财政年份:
    2018
  • 资助金额:
    $ 91.25万
    $ 91.25万
  • 项目类别:
Enhancing patient and organizational readiness for cardiovascular risk reduction among ethnic minority patients living with HIV
加强患者和组织为降低少数族裔艾滋病毒感染者的心血管风险做好准备
  • 批准号:
    10171414
    10171414
  • 财政年份:
    2018
  • 资助金额:
    $ 91.25万
    $ 91.25万
  • 项目类别:
Clinical Trials Network, Ohio Valley Node
临床试验网络,俄亥俄谷节点
  • 批准号:
    7498313
    7498313
  • 财政年份:
    2000
  • 资助金额:
    $ 91.25万
    $ 91.25万
  • 项目类别:
Clinical Trials Network, Ohio Valley Node
临床试验网络,俄亥俄谷节点
  • 批准号:
    7414664
    7414664
  • 财政年份:
    2000
  • 资助金额:
    $ 91.25万
    $ 91.25万
  • 项目类别: