IGF::OT::IGF PHASE II TRIAL OF WEEKLY ERLOTINIB DOSING TO REDUCE DUADENAL POLYP BURDEN ASSOCIATED WITH FAMILIAL ADENOMATOUS POLYPOSIS
IGF::OT::IGF PHASE II TRIAL OF WEEKLY ERLOTINIB DOSING TO REDUCE DUADENAL POLYP BURDEN ASSOCIATED WITH FAMILIAL ADENOMATOUS POLYPOSIS
批准号:
9915384
负责人:
LIMBURG PAUL
金额:
$40.21万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2016
资助国家:
美国
项目状态:
已结题
起止时间:
2016-09-15 至 2021-06-28
关键词:
Adenomatous Polyposis ColiAdverse effectsAdverse eventAggressive FibromatosisAmerican Medical AssociationAnastomosis - actionAnusClinical TrialsDataDoseDuodenal AdenomaDuodenumEpidermal Growth Factor ReceptorErlotinibEsophagogastroduodenoscopyExanthemaExpression ProfilingGastrointestinal PolypGene ExpressionGenesIleal ReservoirsImmune responseJournalsNeoplasmsParticipantPhasePolypsPopulationPublishingSamplingSignal TransductionTimeTissuesclinical efficacycohortdifferential expressionfollow-uporal mucositisphase II trialpost interventionpre-clinicalprimary endpointrectalsecondary endpointstandard of carestatisticssuccessweek trial
中文摘要
先前的研究发现,厄洛替尼的使用与十二指肠肿瘤的显著消退有关。最近发表在《美国医学会杂志》上的一项研究;然而,有显著的不良反应,限制耐受性(如痤疮疹和口腔黏膜炎)。临床前和早期临床试验数据表明,间歇性、每周一次给药厄洛替尼(每日剂量的7倍)保持临床疗效,不良反应较少。
英文摘要
Previous studies have found that the use of erlotinib is associated with marked duodenal neoplasia regression. One study was recently published in the Journal of the American Medical Association; however, there were significant adverse effects that limited tolerability (i.e. acneiform rash and oral mucositis). Preclinical and early phase clinical trial data suggest that intermittent, once weekly dosing of erlotinib (seven times the daily dose) maintains clinical efficacy with fewer adverse effects.
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IGF::OT::IGF PHASE II TRIAL OF WEEKLY ERLOTINIB DOSING TO REDUCE DUADENAL POLYP BURDEN ASSOCIATED WITH FAMILIAL ADENOMATOUS POLYPOSIS
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批准号:9368952
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项目类别:
-
资助金额:$45.72万
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财政年份:2016
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负责人:LIMBURG PAUL
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依托单位:
海外基金