Therapy Evaluation Core

治疗评估核心

• 批准号: 10305363
• 负责人: Jann N. Sarkaria
• 金额: $ 17.53万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10305363
• 关键词: Animals; Brain Neoplasms; Clinical; Clinical Research; Clinical Trials; Clinical Trials Network; Collaborations; Data; Data Analyses; Data Collection; Decision Making; Development; Dose; Drug Kinetics; Evaluation; Glioblastoma; Goals; Human; Modeling; Operative Surgical Procedures; Patients; Pharmacodynamics; Pharmacology; Phase; Phase 0/1 Clinical Trial; Regimen; Research Personnel; Research Support; Safety; Sampling Studies; Schedule; Scientist; Statistical Data Interpretation; Testing; Therapeutic; Therapy Evaluation; Translations; Work; bench to bedside; combinatorial; data management; data quality; design; drug candidate; drug distribution; early phase clinical trial; efficacy evaluation; experimental study; in vivo; innovation; novel; novel therapeutic intervention; novel therapeutics; pharmacokinetics and pharmacodynamics; preclinical evaluation; preclinical study; quality assurance; research clinical testing; treatment strategy; tumor

PROJECT DESCRIPTION/ABSTRACT – THERAPY EVALUATION CORE The goal of our Center of Innovation for Brain Tumor Therapeutics is to nominate only the most promising novel treatment strategies for late-stage clinical testing. This will be accomplished through careful pre-clinical evaluation of potential drug candidates for adequate brain tumor distribution, optimization of dose and schedule for combinatorial regimens, and rigorous efficacy analyses. Combined with careful evaluation of pharmacokinetics (PK) and pharmacodynamics (PD), these studies will be used to establish a PK→PD→efficacy model to predict whether the novel regimen is likely to have adequate distribution and efficacy in human GBM. These predictions then will be tested in Phase 0/I clinical trials in which the safety, tolerability, drug distribution and on-target effects will be tested. Integration of human PK/PD data into our model then will be used to help inform decision making for whether to move specific novel therapies into more advanced Phase II or III clinical trial testing. To accomplish this, the Therapy Evaluation Core and the Pharmacology Core will work closely to support the research being performed within the Projects and the broader Glioblastoma Therapeutics Network (GTN). The scope of work for the Therapy Evaluation Core can be categorized in the two aims described below. Specific Aim 1: Develop, manage and execute in vivo studies in tumor-bearing animals Specific Aim 2: Develop and manage early-phase clinical trial studies

项目描述/摘要-治疗评价核心 我们的脑肿瘤治疗创新中心的目标是只提名最有前途的 用于后期临床试验的新治疗策略。这将通过仔细的临床前 评价潜在候选药物以充分分布脑肿瘤，优化剂量和时间表 用于组合方案和严格的功效分析。结合仔细评估 这些研究将用于确定PK→PD→疗效 模型来预测新方案是否可能在人GBM中具有足够的分布和功效。 然后，这些预测将在0/I期临床试验中进行测试，其中安全性，耐受性，药物分布 并将测试靶向效果。然后将人类PK/PD数据整合到我们的模型中， 为是否将特定的新疗法转入更先进的II期或III期临床研究提供信息决策 试验测试。为实现这一目标，治疗评价核心和药理学核心将密切合作， 支持在项目和更广泛的胶质母细胞瘤治疗网络内进行的研究 （GTN）。治疗评价核心的工作范围可分为以下两个目标。 具体目标1：开发、管理和执行荷瘤动物体内研究 具体目标2：开发和管理早期临床试验研究