PHASE I/II STUDY OF OSI-774 (ERLOTINIB) AND CCI-779 (TEMSIROLIMUS) IN PATIENT

OSI-774（埃洛替尼）和 CCI-779（替西罗莫司）在患者中的 I/II 期研究

• 批准号: 7951542
• 负责人: TIMOTHY CLOUGHESY
• 金额: $ 3.53万
• 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/7951542
• 关键词: Antiepileptic Agents; CCI-779; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Drug Kinetics; Enzymes; Epidermal Growth Factor Receptor; Erlotinib; Funding; Grant; Institution; Malignant Glioma; Maximum Tolerated Dose; Measures; Operative Surgical Procedures; Patients; Pharmaceutical Preparations; Phase; Progression-Free Survivals; Recurrence; Research; Research Personnel; Resources; Safety; Signal Pathway; Source; Specimen; United States National Institutes of Health; human FRAP1 protein; molecular phenotype; 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 (MTD) of OSI-774 (erlotinib; TarcevaTM) in combination with CCI-779 (temsirolimus) in patients with recurrent malignant glioma who are not taking enzyme-inducing anti-epileptic drugs (EIAEDs). 2. To characterize the safety profile of OSI-774 (erlotinib) and CCI-779 (temsirolimus). 3. To characterize the pharmacokinetics of OSI-774 (erlotinib) and CCI-779 (temsirolimus). Phase II: Primary Aim: 1. To determine the efficacy of OSI-774 (erlotinib) and CCI-779 (temsirolimus) in patients with recurrent malignant glioma as measured by 6-month progression-free survival. Secondary Aims: 1. Overall progression-free survival 2. Response Exploratory Aims: 1. To explore the association of response to treatment to the molecular phenotype of the tumor. 2. Determine whether OSI-774 (erlotinib) and CCI-779 (temsirolimus) inhibits EGFR and mTOR and the PI3K-AKT-mTOR and RAS-ERK signaling pathways in tumor specimens taken from malignant glioma patients undergoing surgery. 3. Tumor concentration of OSI-774 (erlotinib) and CCI-779 (temsirolimus).

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 具体目标 第一阶段： 1。在没有复发性恶性神经胶质瘤的患者中，将OSI-774（Erlotinib; Tarcevatm）的最大耐受剂量（MTD）与CCI-779（Temsirolimus）结合使用，这些患者未服用酶的抗杀菌药物（EIAEDS）。 2。表征OSI-774（Erlotinib）和CCI-779（Temsirolimus）的安全性。 3。描述OSI-774（Erlotinib）和CCI-779（Temsirolimus）的药代动力学。 第二阶段： 主要目的： 1。确定OSI-774（Erlotinib）和CCI-779（Temsirolimus）对复发性恶性神经胶质瘤患者的疗效，这是通过6个月的无进展生存率测量的。 次要目的： 1。总体无进展生存 2。响应 探索目的： 1。探索对治疗对肿瘤分子表型的反应的关联。 2。确定OSI-774（Erlotinib）和CCI-779（Temsirolimus）是否抑制EGFR和MTOR，PI3K-AKT-MTOR和RAS-ERK-MTOR和RAS-ERK信号途径中的肿瘤标本中的RAS-ERK信号通路。 3。OSI-774（Erlotinib）和CCI-779（Temsirolimus）的肿瘤浓度。