Phase 1 and 2 Molecular and Clinical Pharmacodynamic Trials ETCTN

1 期和 2 期分子和临床药效学试验 ETCTN

• 批准号: 10784838
• 负责人: A. Dimitrios Colevas
• 金额: $ 159.42万
• 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 2026-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10784838
• 关键词: Acceleration; Adherence; Aftercare; Bioinformatics; Biological Markers; Biopsy; Biostatistics Core; California; Cancer Center; Cancer Therapy Evaluation Program; Cell Cycle Regulation; Cities; Clinic; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Clinical Trials Network; Clinical Trials Support Unit; Collaborations; Combined Modality Therapy; Communication; Comprehensive Cancer Center; Contracts; Credentialing; DNA Repair; Data; Data Coordinating Center; Development; Disease; Dose; Drug Kinetics; Early Therapeutic-Clinical Trials Network; Eligibility Determination; Ensure; Environment; Fellowship; Funding; Goals; Image; Immunooncology; Individual; Infrastructure; Institution; Internet; Interventional radiology; Investigational Drugs; Investigational Therapies; Joints; Laboratories; Lead; Leadership; Letters; Malignant Neoplasms; Mentors; Mentorship; Methodology; Minority Groups; Molecular; Molecular Target; Monitor; National Cancer Institute; Normal tissue morphology; Organizational Affiliation; Outcome; Pathology; Patient Selection; Patients; Pharmaceutical Preparations; Pharmacodynamics; Pharmacogenomics; Pharmacology; Phase; Phase IV Clinical Trials; Policies; Prediction of Response to Therapy; Principal Investigator; Procedures; Productivity; Protocols documentation; Publishing; Recommendation; Recording of previous events; Research; Research Personnel; Resources; Safety; Science; Signal Transduction; Signal Transduction Pathway; Site; Therapeutic; Time; Toxic effect; Translational Research; U-Series Cooperative Agreements; Universities; Validation; Veins; cancer therapy; career; career development; design; early phase clinical trial; early phase trial; improved; innovation; insight; medical specialties; meetings; member; minority patient; multidisciplinary; neoplastic cell; non-invasive imaging; novel; novel anticancer drug; novel therapeutics; pre-clinical; programs; rare cancer; symposium; timeline; translational scientist; tumor; tumor immunology; tumor microenvironment

PROJECT SUMMARY As the California Cancer Consortium (CCC), four National Cancer Institute (NCI)-Designated Cancer Centers propose to participate in the NCI Experimental Therapeutics Clinical Trials Network (ETCTN) to conduct early phase clinical trials of experimental therapeutics. The CCC comprises City of Hope (COH, Lead Academic Organization [LAO]), the University of Southern California (USC, Affiliated Organization [AO]), the University of California, Davis (UCD, AO), and Stanford Cancer Institute (SCI, AO), and has a 25-year history as a multidisciplinary group conducting early phase clinical trials of NCI-sponsored investigational new drugs under previous U01 and UM1 Cooperative Agreements and N01 Contracts. Our multidisciplinary group of investigators will contribute to ETCTN Project Teams by leveraging the combined expertise of COH, UCD, USC, and SCI in 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 use the combined patient and scientific resources and expertise of UCD, COH, USC, and SCI to accomplish the following Specific Aims: (Aim 1) to use the existing relevant capabilities and scientific leadership of the CCC to enhance the ETCTN program; (Aim 2) to leverage the combined breadth of the clinical programs at COH, USC, UCD, and SCI NCI-Designated Comprehensive Cancer Centers to support the rapid completion of ETCTN trials; (Aim 3) to use the central Data Coordinating Center (DCC) and Biostatistics Core (BC) at COH to facilitate frequent communication within the CCC and with the NCI and ETCTN, provide rapid development and effective oversight of trials, and ensure adherence to policies and procedures; and (Aim 4) to optimize information gained from ETCTN clinical trials by including molecular characterization of patients’ malignancies and incorporating molecular pharmacodynamic endpoints and investigational imaging. These early phase studies will lead to recommended, biologically effective doses, greater understanding of the spectrum of normal tissue toxicity of agents, and initial estimates of efficacy. They will also provide mechanistic validation of the effects of the agents on critical tumor cell targets, correlate drug-related changes in tumor and host biologic markers with clinical outcome, and develop new insights into the therapeutic mechanisms of action of the compounds both in the laboratory and the clinic. As such, they will advance the ETCTN’s overall goal of accelerating the development of novel anticancer agents that capitalize on unique molecular features of individual tumors and identifying appropriate biomarkers to select patients who are most likely to respond to specific agents.

项目摘要 作为加利福尼亚癌症联盟（CCC），四个国家癌症研究所（NCI）指定的癌症中心 建议参加NCI实验疗法临床网络（ETCTN）进行早期进行 实验治疗的阶段试验CCC包括希望之城 组织[老挝]），南加州大学（USC，附属组织[AO]），大学 加利福尼亚州，戴维斯（UCD，AO）和斯坦福癌症研究所（SCI，AO），历史25年 多学科的组进行NCI赞助的研究新药的早期临床临床 以前的U01和UM1合作协议和N01合同。 通过利用COH，UCD和SCI的联合专业知识来为ETCTN项目团队做出贡献 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 周期调节，非侵入性成像和生物信息学以进行创新的实验室导演早期阶段 发育和药代动力学研究。 以及UCD，COH，USC和SCI的专业知识，以完成以下特定AMS ：（目标1） CCC的现有相关能力和科学领导力增强ETCTN计划（目标2） 利用COH，USC，UCD和SCI指定的临床计划的综合广度 全面的癌症中心以快速压实等。（目标3）使用中央数据 COH的协调中心（DCC）和生物统计学核心（BC），以促进频繁的通信 CCC以及NCI和ETCTN，提供快速发展和有效的试验监督，并确保 遵守政策和程序； 包括患者恶性肿瘤的分子表征并掺入分子药效学 终点和研究成像。 剂量，对药物正常组织的光谱的了解以及功效的初始估计。 他们还将提供机械验证药物对关键肿瘤细胞靶标的影响 具有临床结果的肿瘤和宿主生物标记的与药物有关的变化，并将新见解发展为 实验室和诊所组成的治疗机制 推进等等 单个肿瘤肿瘤的独特分子特征，并确定适当的生物标志物以选择患者 最有可能对特定代理作出反应。