IGF::OT::IGF PHASE II TRIAL OF WEEKLY ERLOTINIB DOSING TO REDUCE DUADENAL POLYP BURDEN ASSOCIATED WITH FAMILIAL ADENOMATOUS POLYPOSIS

IGF::OT::IGF 每周给药厄洛替尼以减少与家族性腺瘤性息肉病相关的十二指肠息肉负担的 II 期试验

• 批准号: 9368952
• 负责人: LIMBURG PAUL
• 金额: $ 45.72万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-15 至 2018-09-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9368952
• 关键词: Adenomatous Polyposis Coli; Adverse effects; Adverse event; Aggressive Fibromatosis; American Medical Association; Anastomosis - action; Anus; Clinical Trials; Data; Dose; Duodenal Adenoma; Epidermal Growth Factor Receptor; Erlotinib; Esophagogastroduodenoscopy; Exanthema; Gastrointestinal Polyp; Gene Expression; Genes; Ileal Reservoirs; Immune response; Journals; Molecular Profiling; Neoplasms; Participant; Phase; Polyps; Population; Publishing; Sampling; Signal Transduction; Time; Tissues; clinical efficacy; cohort; differential expression; follow-up; oral mucositis; phase II trial; post intervention; pre-clinical; rectal; standard of care; statistics; success

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.

先前的研究发现，厄洛替尼的使用与明显的十二指肠肿瘤回归有关。 一项研究最近发表在《美国医学协会杂志》上。然而，存在限制耐受性（即弓形性皮疹和口腔粘膜炎）的显着不利影响。 临床前和早期临床试验数据表明，每周erlotinib（每日剂量的七倍）每周给予间歇性均保持临床疗效，而不良反应较少。