UCLA IRB # 06-04-104 "A PHASE I/II, DUAL-CENTER, OPEN-LABEL TRIAL OF THE SAFE

加州大学洛杉矶分校IRB

• 批准号: 8167095
• 负责人: TIMOTHY CLOUGHESY
• 金额: $ 2.7万
• 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: 2009-12-01 至 2010-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8167095
• 关键词: Adult; Combined Modality Therapy; Computer Retrieval of Information on Scientific Projects Database; Deletion Mutation; Dose; Epidermal Growth Factor Receptor; Erlotinib; Funding; Grant; Institution; Malignant Glioma; Molecular; Mutation; Operative Surgical Procedures; PTEN gene; Patients; Phase; Progression-Free Survivals; Recurrence; Relapse; Research; Research Ethics Committees; Research Personnel; Resources; Role; Schedule; Sirolimus; Somatic Mutation; Source; Time; United States National Institutes of Health; arm; mutant; open label; response

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: Primary Objectives The phase I component of this study will determine the MTD and DLT of escalating doses of erlotinib in combination with sirolimus, both administered on a continuous once daily dosing schedule to adult patients with malignant glioma, who are not receiving EIAED; The phase II component of this study will evaluate preliminary efficacy (response rate [RR], progression free survival [PFS] and overall survival [OS]) of erlotinib and sirolimus combination therapy in GBM/GS patients who are not undergoing surgery at the time of recurrence or relapse (dose expansion arm; Evaluate molecular determinants of response to this combination of erlotinib and sirolimus, especially the roles of the mutation of EGFR (vIII mutant and other somatic mutations of vIII and mutation/deletion of PTEN.

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 具体目标： 主要目标 这项研究的I期部分将确定递增剂量的厄洛替尼与西罗莫司联合给药的MTD和DLT，这两种药物都是按每日一次的连续给药计划给没有接受EIAED治疗的成年恶性胶质瘤患者服用； 这项研究的第二阶段部分将评估埃罗替尼和西罗莫司联合治疗复发或复发时未接受手术的GBM/GS患者的初步疗效(应答率[RR]、无进展生存率[PFS]和总生存率[OS])(剂量扩展臂； 评估埃洛替尼和西罗莫司联合应用的分子决定因素，特别是表皮生长因子受体的突变(突变和的其他体细胞突变)以及PTEN的突变/缺失所起的作用。