Clinical Trial: YF476 and Type II Gastric Carcinoids

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: A Pilot Trial of YF476, a Gastrin Antagonist, in Patients With Type II Gastric Carcinoids Associated With Zollinger-Ellison Syndrome

Brief Summary: This study will evaluate whether treatment with YF476 is safe and effective in reducing the size of type II gastric carcinoid tumours, or limiting the abnormal growth of gastric ECL cells, in patients with Zollinger-Ellison syndrome.

Detailed Summary:
Sponsor: Trio Medicines Ltd.

Current Primary Outcome: Regression of gastric carcinoids and/or ECL cell hyperplasia defined by physical measurements taken during endoscopy [ Time Frame: Up to 10 years ]

Regression is defined as a 25% reduction in the size / number of endoscopically evident type II gastric carcinoids; or a reduction of 25% in the gastric ECL cell density.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Improvement in histological grade of gastric carcinoids/ECL cell hyperplasia defined by physical measurements taken during endoscopy [ Time Frame: Up to 10 years ]
    Reduction in the histological grade of the carcinoids/hyperplasia when compared to baseline.
  • Level of gastrin and chromogranin A (CgA) biomarkers measured in blood samples [ Time Frame: Up to 10 years ]
    Reduction in the levels of circulating gastrin and CgA biomarkers.
  • Control of gastric acid secretion assessed by changes in drug-controlled gastric acid analysis (acid control study) [ Time Frame: Up to 10 years ]
    Assessed by changes in drug-controlled gastric acid analysis.
  • Decrease in ECL cell-specific products assessed by quantitative PCR [ Time Frame: Up to 10 years ]
    Assessed by quantitiative PCR.
  • Improvement in reflux/dyspepsia symptoms using the GERD-HRQL instrument [ Time Frame: Up to 10 years ]
    Assessed by the GERD-HRQL instrument.
  • Safety and tolerability by monitoring adverse events [ Time Frame: Up to 10 years ]
    The treatment is safe and well tolerated when added to existing treatments for ZES.


Original Secondary Outcome: Same as current

Information By: Trio Medicines Ltd.

Dates:
Date Received: May 13, 2015
Date Started: April 2011
Date Completion: January 2024
Last Updated: May 21, 2015
Last Verified: May 2015