A trial of YF476 in patients with type II gastric carcinoids
A trial of YF476 in patients with type II gastric carcinoids
批准号:
8349968
负责人:
Stephen Wank
金额:
$7.58万
依托单位国家:
美国
项目类别:
财政年份:
--
资助国家:
美国
项目状态:
未结题
起止时间:
至
关键词:
Adverse eventAlgorithmsBiochemicalBiochemical MarkersBiological MarkersBiopsyBloodCarcinoid TumorCell DensityChromograninsDoseDyspepsiaDysplasiaEndoscopyEnrollmentEnterochromaffin-like CellsGastric AcidGastric Carcinoid TumorGastroesophageal reflux diseaseGrowthHyperplasiaMonitorOral cavityPatientsPharmaceutical PreparationsPhasePilot ProjectsPlasmaProductionProtocols documentationRefluxSafetySerumStomachSymptomsTestingTimeToxicologyUnited States National Institutes of HealthUrineVisitbasehealthy volunteerimprovedopen labelpilot trial
中文摘要
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英文摘要
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.
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