NOVEL THERAPEUTICS

中北部癌症治疗小组的新型治疗委员会是一个新的委员会，旨在促进和协调将新型治疗方法以及反应和毒性预测因子引入NCCTG的疾病部位计划。该委员会的职责是通过与马约诊所癌症中心项目和其他组织项目的互动，促进新治疗研究的发展，将其纳入NCCTG的研究项目。委员会的具体目标是：1。为选定的Ib/II期临床试验提供建议并促进其发展。这些试验可能包括新药物与标准药物的组合或已批准药物的组合。2.与NCCTG的疾病中心委员会合作，开展选定的药代动力学药物研究，如基于人群的药代动力学、有限采样模型的检测、器官功能障碍中的药物处置以及老年人中的药物药代动力学/药效学。3.评价在马约诊所癌症中心和其他组织的研究项目中发现的反应和毒性的新标志物。这些标志物将在与实验室科学委员会和特定疾病现场主席的讨论中选择。拟议工作的意义在于，这些研究将建立从实验室到第一阶段再到第二阶段评价的逻辑进程。II期评价对于确认使用生物标志物在临床前模型中描述的机制至关重要，这些生物标志物已被确定为在I期试验期间可能适用于更广泛的临床试验。先前已经开展的工作和拟议的项目详见下文报告。

The Novel Therapeutics Committee of the North Central Cancer Treatment Group is a new committee designed to facilitate and coordinate the introduction of novel therapeutic approaches and predictors of response and toxicity into disease site programs of the NCCTG. The charge of the committee is to promote the development of novel therapeutic studies into the research programs of the NCCTG through interaction with the Mayo Clinic Cancer Center programs and programs at other organizations. The specific goals of the committee are: 1. To advice and facilitate development of selected phase Ib/II clinical trials. These trials could include combinations of novel agents with standard drugs or combinations of approved drugs. 2. To develop selected pharmacokinetic drug studies, such as population- based pharmacokinetics, testing of limited sampling models, drug disposition in organ dysfunction, and drug pharmacokinetics/pharmacodynamics in the elderly in collaboration with the disease site committees of the NCCTG. 3. To evaluate novel markers of response and toxicity that have been identified in research programs of the Mayo Clinic Cancer Center and other organizations. Such markers would be selected in discussions with the Laboratory Science Committee and specific disease site chairs. The significance of the work proposed is that the studies will build a logical progression from the laboratory through phase I into phase II evaluation. The phase II evaluation is critical to the confirmation of the mechanisms which have been delineated in the preclinical models using biomarkers that have been identified as potentially feasible to apply in broader clinical testing during phase I testing. Previous work that has already been undertaken and proposed projects are detailed in the report that follows.