A trial of YF476 in patients with type II gastric carcinoids

这是一项评价YF 476治疗II型胃类癌和/或ECL细胞增生/异型增生的有效性和安全性的II期、开放标签、初步试验。 本方案的目的是评估YF 476是否可以使内镜下可见的II型胃类癌的大小或数量减少25%;或者是否可以改善胃类癌和/或ECL细胞增生的组织学分级。 正在研究的其他作用包括：YF 476是否可以控制和维持胃酸产生;是否对血清生物标志物（即嗜铬粒蛋白水平）有任何影响;基于GERD-HRQL的反流/消化不良症状改善;以及，当添加到其他伴随药物中时，是否安全且耐受良好。找出YF 476治疗是否安全和有效地实现ZES患者的II型胃类癌肿瘤或胃ECL细胞的异常生长的消退。 由于频繁访问NIH的繁琐次数，该方案的累积一直很慢。 目前，已有两名患者入组，并且对药物耐受良好。前2名尚未完成研究的患者的初步结果似乎很有希望。

This is a Phase 2, open-label, pilot trial of the efficacy and safety of YF476 in the treatment of type II gastric carcinopids and /or ECLcell hyperplasia/dysplasia in patients with ZEs. Thee purpose of this protocol is to assess if YF476 can have a 25% reduction in the size or number of endoscopically visible type II gastric carcinoids; or if it can improve histological grade of gastric carcinoids and/or ECL cell hyperplasia. Other effects being studied are: if YF476 can control and maintain gastric acid production; if it has any effect on serum biomarker (ie; chromogranin level); improvement in reflux/dyspepsia symptoms based on GERD-HRQL; and, if it safe and well tolerated when added to other concomitant medications in ZEs patients. find out whether treatment with YF476 is safe and effective at achieving regression of type II gastric carcinoid tumors, or the abnormal growth of gastric ECL cells, in patients with ZES. Due to the cumbersome number of frequent visits to the NIH, accrual for this protocol has been slow. At this time, two patients are currently enrolled and have tolerated the drug well. Preliminary results from the first 2 patients, who have not yet completed the study, appear to be promising.