UCLA IRB # 06-04-104 "A PHASE I/II, DUAL-CENTER, OPEN-LABEL TRIAL OF THE SAFE
UCLA IRB # 06-04-104 "A PHASE I/II, DUAL-CENTER, OPEN-LABEL TRIAL OF THE SAFE
批准号:
8167095
负责人:
TIMOTHY CLOUGHESY
金额:
$2.7万
依托单位国家:
美国
项目类别:
财政年份:
2009
资助国家:
美国
项目状态:
已结题
起止时间:
2009-12-01 至 2010-11-30
关键词:
AdultCombined Modality TherapyComputer Retrieval of Information on Scientific Projects DatabaseDeletion MutationDoseEpidermal Growth Factor ReceptorErlotinibFundingGrantInstitutionMalignant GliomaMolecularMutationOperative Surgical ProceduresPTEN genePatientsPhaseProgression-Free SurvivalsRecurrenceRelapseResearchResearch Ethics CommitteesResearch PersonnelResourcesRoleScheduleSirolimusSomatic MutationSourceTimeUnited States National Institutes of Healtharmmutantopen labelresponse
中文摘要
这个子项目是许多研究子项目中的一个
由NIH/NCRR资助的中心赠款提供的资源。子项目和
研究者(PI)可能从另一个NIH来源获得了主要资金,
因此可以在其他CRISP条目中表示。所列机构为
研究中心,而研究中心不一定是研究者所在的机构。
具体目标:
主要目标
本研究的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,这两种药物均以每日一次连续给药方案给予未接受EIAED的恶性胶质瘤成人患者;
本研究的II期部分将评估厄洛替尼和西罗莫司联合治疗在复发或复发时未接受手术的GBM/GS患者中的初步疗效(应答率[RR]、无进展生存期[PFS]和总生存期[OS])(剂量扩展组;
评价对厄洛替尼和西罗莫司联合治疗应答的分子决定因素,尤其是EGFR突变(vIII突变体和其他vIII体细胞突变以及PTEN突变/缺失)的作用。
英文摘要
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.
期刊论文(0)
专著(0)
科研奖励(0)
会议论文
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批准号:10590620
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资助金额:$60.57万
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财政年份:2022
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负责人:TIMOTHY CLOUGHESY
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依托单位:
Role of decorin and diffusion MRI in anti-VEGF efficacy for recurrent glioblastoma
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资助金额:$7.37万
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财政年份:2017
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依托单位:
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批准号:7951564
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项目类别:
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资助金额:$2.37万
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财政年份:2009
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负责人:TIMOTHY CLOUGHESY
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依托单位:
PHASE I/II STUDY OF OSI-774 (ERLOTINIB) AND CCI-779 (TEMSIROLIMUS) IN PATIENT
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批准号:8167082
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项目类别:
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资助金额:$0.07万
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财政年份:2009
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负责人:TIMOTHY CLOUGHESY
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依托单位:
UCLA IRB # 06-04-104 "A PHASE I/II, DUAL-CENTER, OPEN-LABEL TRIAL OF THE SAFE
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批准号:7951565
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项目类别:
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资助金额:$1.59万
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财政年份:2009
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负责人:TIMOTHY CLOUGHESY
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依托单位:
UCLA IRB # 06-04-016 "PHASE II TRIAL OF BEVACIZUMAB IN COMBINATION WITH TEMOZ
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批准号:8167096
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项目类别:
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资助金额:$14.11万
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财政年份:2009
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负责人:TIMOTHY CLOUGHESY
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依托单位:
UCLA IRB #05-12-061 "A PHASE I STUDY OF VORINOSTAT (SUBEROYLANILIDE HYDROXAMI
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批准号:7951558
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项目类别:
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资助金额:$0.22万
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财政年份:2009
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负责人:TIMOTHY CLOUGHESY
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依托单位:
UCLA IRB 08-09-042: PHASE I TRIAL OF AFLIBERCEPT (VEGF TRAP) WITH RADIATION THE
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批准号:8167134
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项目类别:
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资助金额:$0.99万
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财政年份:2009
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负责人:TIMOTHY CLOUGHESY
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依托单位:
UCLA IRB # 06-04-016 "PHASE II TRIAL OF BEVACIZUMAB IN COMBINATION WITH TEMOZ
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批准号:7951566
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项目类别:
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资助金额:$17.02万
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财政年份:2009
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负责人:TIMOTHY CLOUGHESY
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依托单位:
PHASE II SINGLE ARM TRIAL OF VEGF TRAP IN PATIENTS WITH RECURRENT TEMOZOLOMIDE-
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批准号:7951575
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项目类别:
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资助金额:$0.17万
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财政年份:2009
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负责人:TIMOTHY CLOUGHESY
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依托单位:
PHASE I/II STUDY OF OSI-774 (ERLOTINIB) AND CCI-779 (TEMSIROLIMUS) IN PATIENT
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批准号:7951542
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项目类别:
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资助金额:$3.53万
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财政年份:2009
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负责人:TIMOTHY CLOUGHESY
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依托单位:
CONSORTIUM THERAPEUTIC STUDIES OF PRIMARY CENTRAL NERVI*
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批准号:7724330
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项目类别:
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资助金额:$0.26万
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财政年份:2008
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负责人:TIMOTHY CLOUGHESY
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依托单位:
PHASE II TRIAL OF EMD 121974 FOR RECURRENT GLIOBLASTOMA: A CLINICAL TRIAL WIT
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项目类别:
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资助金额:$6.63万
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财政年份:2007
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负责人:TIMOTHY CLOUGHESY
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依托单位:
A BIOMARKER AND PHASE II STUDY OF GW 572016 IN RECURRENT MALIGNANT GLIOMA (NA
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批准号:7717990
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项目类别:
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资助金额:$0.14万
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财政年份:2007
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负责人:TIMOTHY CLOUGHESY
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依托单位:
CLINICAL TRIAL: A PHASE II TRIAL OF POLY-ICLC IN PATIENTS WITH RECURRENT ANAPLAS
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批准号:7717972
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项目类别:
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资助金额:$0.18万
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财政年份:2007
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负责人:TIMOTHY CLOUGHESY
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依托单位:
UCLA IRB #05-12-061 "A PHASE I STUDY OF VORINOSTAT (SUBEROYLANILIDE HYDROXAMI
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批准号:7606832
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项目类别:
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资助金额:$1.2万
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财政年份:2007
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负责人:TIMOTHY CLOUGHESY
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依托单位:
CONSORTIUM THERAPEUTIC STUDIES OF PRIMARY CENTRAL NERVI*
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批准号:7627686
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项目类别:
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资助金额:$2.01万
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财政年份:2007
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负责人:TIMOTHY CLOUGHESY
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依托单位:
RECURRENT TEMOZOLOMIDE-RESISTANT MALIGNANT GLIOMAS
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批准号:7718036
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项目类别:
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资助金额:$0.36万
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财政年份:2007
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负责人:TIMOTHY CLOUGHESY
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依托单位:
海外基金