Phase I Molecular and Clinical Pharmacodynamic Trials ETCTN

I 期分子和临床药效试验 ETCTN

• 批准号: 9095678
• 负责人: PRIMO N. LARA
• 金额: $ 87.11万
• 依托单位: BECKMAN RESEARCH INSTITUTE/CITY OF HOPE
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-03-28 至 2020-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9095678
• 关键词: Area; Bioinformatics; Biological Markers; Blood; California; Cancer Center; Cell Cycle Regulation; City of Hope Comprehensive Cancer Center; Clinical; Clinical Drug Development; Clinical Trials; Clinical Trials Network; Collection; Communication; Comprehensive Cancer Center; Contracts; Correlative Study; Cytostatics; Data; Data Coordinating Center; Development; Drug Kinetics; Drug Targeting; Early Therapeutic-Clinical Trials Network; Effectiveness; Ensure; Funding; Image; Immunotherapeutic agent; Immunotherapy; Investigational Therapies; Laboratories; Lead; Malignant Neoplasms; Mentorship; Methodology; Methods; Molecular; Molecular Profiling; Molecular Target; Nature; Normal tissue morphology; Outcome; Patient-Focused Outcomes; Patients; Pattern; Pharmaceutical Preparations; Pharmacodynamics; Pharmacogenomics; Pharmacology; Phase; Phase I Clinical Trials; Phase II Clinical Trials; Phenotype; Pre-Clinical Model; Procedures; Process; Productivity; Public Health; Quality Control; Research Activity; Research Design; Research Infrastructure; Research Personnel; Resistance; Resources; Safety; Sampling; Signal Transduction; Site; Specimen; Staging; Statistical Methods; Structure; Therapeutic; Therapeutic Agents; Therapeutic Clinical Trial; Training; Translational Research; Tumor Markers; Tumor Tissue; U-Series Cooperative Agreements; Universities; base; cancer therapy; career; career development; clinically relevant; data management; design; drug development; individual patient; innovation; molecular subtypes; multidisciplinary; non-invasive imaging; novel; novel anticancer drug; novel therapeutics; oncology; phase 2 study; precision medicine; predicting response; programs; public health relevance; screening; targeted treatment; translational study; tumor

 DESCRIPTION (provided by applicant): The purpose of this Revision to our UM1 Cooperative Agreement is to enhance the NCI-supported early development of experimental cancer therapeutics by merging the Phase 2 clinical trials program with the Experimental Therapeutics Clinical Trials Network (ETCTN) that is currently focused on Phase 1 clinical trials. The California Cancer Consortium (CCC) consists of the City of Hope Comprehensive Cancer Center (COH, the "Lead Academic Organization," [LAO]), the University of California, Davis Cancer Center (UCD, Affiliated Organization [AO]), and the University of Southern California (USC)/Norris Comprehensive Cancer Center (USC, AO) and will add Stanford University Cancer Center (AO) with this Revision to our UM1. The CCC will integrate our extensive Phase 2 clinical trials program (currently funded through an NCI contract, "N01") into a single administrative structure participating in the ETCTN. Our multidisciplinary group of investigators will contribute to ETCTN agent-specific trans-network drug development "Project Teams" from the combined expertise of COH, UCD, USC, and SU in the areas of molecular pharmacology, pharmacokinetics, pharmacodynamics, pharmacogenomics, signal transduction, cell cycle regulation, non-invasive imaging, and bioinformatics to conduct innovative, laboratory-directed early phase developmental and pharmacokinetic studies. We propose to utilize the combined patient and scientific resources and expertise of UCD, COH, USC, and SU to accomplish the following Specific Aims: (Aim 1) to rapidly design, initiate and complete laboratory-driven Phase 2 clinical trials evaluating the safety and efficacy of NCI-sponsored agents, alone or in combination, in order to maximize the patient, scientific, and mentorship/career development resources of an established Consortium with demonstrated expertise in clinical drug development; (Aim 2) to employ a systematic approach to collection, processing, and storage of blood, normal and tumor tissue, and other relevant biologic samples for molecular and pharmacologic studies in the context of Phase 2 oncology trials; and (Aim 3) to develop scientific rationale for proposed trials using advanced preclinical models; to evaluate biologic effects of novel therapeutics (including immunotherapy) on their molecular or biologic targets; to incorporate appropriate study designs, imaging, and statistical methods for assessment of intermediate endpoints; and to correlate findings with clinically relevant outcomes in the Phase 2 setting. A single Data Coordinating Center located at the LAO currently manages participation (clinical trial management, patient accrual, and communication with multiple NCI components and staff) by the LAO and all CCC AOs for both NCI-Sponsored Phase 1 trials (under the current UM1) and Phase 2 trials (under the current N01 contract), which will make the incorporation of the current CCC Phase 2 program into the ETCTN structure seamless.

 描述（由申请人提供）：本次 UM1 合作协议修订的目的是通过将 2 期临床试验计划与实验治疗临床试验网络 (ETCTN) 合并，加强 NCI 支持的实验性癌症治疗的早期开发。目前专注于 1 期临床试验的加州癌症联盟 (CCC) 由希望之城综合癌症中心（COH，“领先学术组织”）组成。 [LAO]）、加州大学戴维斯癌症中心（UCD，附属组织 [AO]）和南加州大学 (USC)/诺里斯综合癌症中心 (USC，AO)，并将增加斯坦福大学癌症中心（通过对 UM1 的修订，CCC 将把我们广泛的 2 期临床试验计划（目前通过 NCI 合同“N01”资助）整合到参与 ETCTN 的单一管理结构中。研究小组将汇集 COH、UCD、USC 和 SU 在分子药理学、药代动力学、药效学、药物基因组学、信号转导、细胞周期等领域的专业知识，为 ETTCTN 药物特异性跨网络药物开发“项目团队”做出贡献我们建议利用 UCD、COH、USC 的综合患者和科学资源以及专业知识来进行创新的、实验室指导的早期发育和药代动力学研究。 SU 实现以下具体目标：（目标 1）快速设计、启动和完成实验室驱动的 2 期临床试验，评估 NCI 资助的药物单独或组合的安全性和有效性，以最大限度地提高患者的科学性和科学性。以及具有临床药物开发专业知识的已建立联盟的指导/职业发展资源（目标 2），采用系统方法收集、处理和储存血液、正常组织和肿瘤组织以及其他相关的分子生物样本；和药理学研究2 期肿瘤学试验的背景；以及（目标 3）使用先进的临床前模型为拟议的试验制定科学依据，以评估新疗法（包括免疫疗法）对其分子或生物靶点的生物效应，以纳入适当的研究设计、成像；以及用于评估中间终点的统计方法；并将结果与​​第 2 阶段环境中的临床相关结果相关联。目前，位于 LAO 的单一数据协调中心负责管理参与（临床试验管理、患者）。 LAO 和所有 CCC AO 对于 NCI 赞助的第一阶段试验（根据当前的 UM1）和第二阶段试验（根据当前的 N01 合同）进行应计费用以及与多个 NCI 部门和工作人员的沟通），这将使目前的CCC第二阶段计划无缝融入ETCTN结构。