University of Arizona Cancer Prevention Clinical Trials Network (UA CP-CTNet)

项目总结 随着对癌症发生过程的分子理解的进展，人们对一种越来越多的 截取癌症发展早期阶段的药物数量，包括最近对 免疫预防。亚利桑那大学癌症预防临床试验网络(UA)的总体目标 CP-CTNet)将进行早期临床试验，以评估假定的预防药物的生物效果 并确定与临床相关的相关因素，以确定具有良好安全性的药物和初步的 最终的第三阶段试验的有效性。 UA CP-CTNet由来自不同专业的医生、统计学家、临床工作人员、数据 经理、病理学家、翻译科学家和其他在早期阶段具有丰富经验的人员 癌症预防药物的临床试验和在不同器官部位的翻译研究。 具体而言，UA CP-CTNet将： ·有效地设计和进行0/I/II期临床试验，以评估 影响多种慢性病的改变用途的药物，特性良好的营养制剂， 从转化研究中确定的区域/局部药物传递和免疫调节剂， 流行病学研究和/或临床研究。 ·描述可能的癌症预防药物对其临床活性和生物学效应 确定的分子/生化目标、免疫监测网络、相关的替代终点 以及在临床前研究中确定的其他生物效应标记物。 ·进一步发展对所研究和研究的制剂的癌症预防机制的科学见解 开发新的潜在标记作为反应的决定因素并用于选择 可能会从研究的试剂中获得不同的好处。 通过拟议的研究，我们期望进行严格设计的早期癌症预防临床 确定潜在预防药物的临床活性和生物效应的试验。这项研究 这些发现将进一步加深对癌症预防机制的科学见解，并开发新的潜力 生物标志物作为反应的决定因素。从这些早期阶段产生的科学和临床证据 癌症预防临床试验将为进一步的临床发展做出“不通过”的决定。 用于癌症预防的推定试剂。

PROJECT SUMMARY Advances in molecular understanding of the process of carcinogenesis have led to the study of an increasing number of agents to intercept the early phases of cancer development, including the recent interest in immunoprevention. The overall objective of University of Arizona Cancer Prevention Clinical Trials Network (UA CP-CTNet) is to perform early phase clinical trials to evaluate the biologic effects of putative preventive agents and to determine clinically relevant correlates in order to identify agents with good safety profiles and preliminary efficacy for definitive Phase III trials. The UA CP-CTNet consists of a team of physicians from diverse specialties, statisticians, clinical staff, data managers, pathologists, translational scientists, and other personnel with extensive experience in early phase clinical trials of cancer preventive agents and in translational research in various organ sites. Specifically, the UA CP-CTNet will: • Efficiently design and conduct Phase 0/I/II clinical trials to assess the cancer preventive potential of repurposed drugs that affect multiple chronic diseases, well-characterized nutraceutical agents, regional/topical drug delivery, and immune modulators, identified from translational research, epidemiological studies, and/or clinical research. • Characterize the clinical activity and biological effects of putative cancer preventive agents on their defined molecular/biochemical targets, the immune surveillance network, surrogate endpoints associated with carcinogenesis, and other biological effect markers identified in preclinical studies. • Develop further scientific insights into the mechanisms of cancer prevention by the agents studied and to develop novel potential markers as determinants of response and for selecting subpopulations who may differentially benefit from the studied agent. Through the proposed research, we expect to conduct rigorously designed early phase cancer prevention clinical trials that determine the clinical activity and biological effects of potential preventive agents. The research findings will further scientific insights into the mechanisms of cancer prevention and develop novel potential biomarkers as determinants of response. Scientific and clinical evidence generated from these early phase cancer prevention clinical trials will contribute significantly to “go-no go” decisions for further clinical development of putative agents for cancer prevention.