UCLA IRB (PENDING) "A PHASE I/II STUDIES OF BAY 43-9006 (SORAFENIB) IN COMBIN

加州大学洛杉矶分校 IRB（待定）“Bay 43-9006（索拉非尼）组合的 I/II 期研究

• 批准号: 7951564
• 负责人: TIMOTHY CLOUGHESY
• 金额: $ 2.37万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-04-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7951564
• 关键词: Antiepileptic Agents; BAY 54-9085; Biological Markers; Blood; CCI-779; Clinical; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Diagnosis; Dose; Drug Interactions; Drug Kinetics; Enzymes; Excision; Funding; Glioblastoma; Grant; Institution; Laboratory Study; Maximum Tolerated Dose; Measures; Molecular Target; Outcome; Patients; Pharmaceutical Preparations; Phase; Progression-Free Survivals; Protocols documentation; Recurrence; Research; Research Ethics Committees; Research Personnel; Resources; Safety; Signal Transduction Pathway; Source; Time; Tissues; United States National Institutes of Health; gliosarcoma; response; tumor

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. SPECIFIC AIMS: Phase I: 1. To define the maximum tolerated dose of R115777, OSI-774, or CCI-779 in combination with a fixed dose of BAY 43-9006, in patients with recurrent glioblastoma or gliosarcoma who are not taking enzyme-inducing antiepileptic drugs (EIAEDs). 2. To characterize the safety profile of the doublet combinations of R115777-BAY 43-9006, OSI-774-BAY 43-9006 and CCI-779-BAY 43-9006 in patients with recurrent glioblastoma or gliosarcoma. 3. To characterize the pharmacokinetics of these doublet combinations, evaluating single agent pharmacokinetics of each agent then the combination pharmacokinetics to determine drug-drug interactions. Phase II: 1. To determine the efficacy of each of the doublet combinations in patients with recurrent glioblastoma or gliosarcoma as measured by 6-month progression-free survival. 2. To determine the efficacy of each of the doublet combinations in patients with recurrent glioblastoma or gliosarcoma as measured by 12-month survival and objective tumor response. 3. To further characterize the safety profile of each of the doublet combinations. 4. To characterize the pharmacokinetics of each of the doublet combinations in a subset of the phase II patients to further define possible drug-drug interactions. 5. To perform exploratory correlative laboratory studies by examining tissue markers of signal transduction pathways by immunohistochemical analysis using tissue blocks obtained prior to initiation of protocol therapy, either from the time of diagnosis or subsequent tumor resection. 6. For the Molecular Targeted Combinations Correlative (MTC2) Study Initiative: To determine the relationship between tumor and blood biomarkers and clinical outcome of patients treated with the combination of targeted agents.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 具体目标： 第一阶段： 1. 确定未服用酶诱导抗癫痫药物 (EIAED) 的复发性胶质母细胞瘤或胶质肉瘤患者中 R115777、OSI-774 或 CCI-779 与固定剂量 BAY 43-9006 组合的最大耐受剂量。 2. 表征 R115777-BAY 43-9006、OSI-774-BAY 43-9006 和 CCI-779-BAY 43-9006 双联组合在复发性胶质母细胞瘤或胶质肉瘤患者中的安全性。 3.为了表征这些双重组合的药代动力学，评估每种药物的单药药代动力学，然后评估组合药代动力学以确定药物-药物相互作用。 第二阶段： 1. 通过 6 个月无进展生存期来确定每种双重组合对复发性胶质母细胞瘤或胶质肉瘤患者的疗效。 2. 通过 12 个月生存率和客观肿瘤反应来衡量，确定每种双重组合对复发性胶质母细胞瘤或胶质肉瘤患者的疗效。 3. 进一步表征每种双联体组合的安全性。 4. 表征 II 期患者子集中每种双联组合的药代动力学，以进一步确定可能的药物-药物相互作用。 5. 通过使用在开始方案治疗之前（从诊断时或随后的肿瘤切除时）获得的组织块，通过免疫组织化学分析检查信号转导途径的组织标记物，进行探索性相关实验室研究。 6. 分子靶向组合相关（MTC2）研究计划：确定肿瘤和血液生物标志物与接受靶向药物组合治疗的患者临床结果之间的关系。