Pilot trial of YF476 in patients with gastric carcinoids; version 1

• Research type

  Research Study

• Full title

  A single centre, pilot trial of YF476 in patients with chronic atrophic gastritis, hypergastrinaemia and type I gastric carcinoids

• IRAS ID

  45888

• Contact name

  Mark Pritchard

• Sponsor organisation

  Trio Medicines Ltd

• Eudract number

  2007-002916-24

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The aim of the study is to find out if the experimental medicine, YF476, can make gastric carcinoids, a rare type of stomach tumour, shrink and disappear. Gastric carcinoids occur mainly in patients with chronic atrophic gastritis (CAG), a condition in which the acid-producing cells in the lining of the stomach can??t make acid. Acid production is controlled by gastrin, a hormone (chemical messenger) that??s released into the bloodstream. If the stomach can??t make acid, blood levels of gastrin rise. High blood levels of gastrin in patients with CAG can cause other cells (ECL cells) in the lining of the stomach to grow and, over the years, to give rise to gastric carcinoids. Gastric carcinoids are usually benign, but they can become malignant. Therefore, patients with CAG and gastric carcinoids have the inside of their stomach checked regularly, by gastroscopy, to see if the gastric carcinoids need removing surgically. A gastroscope is a thin (1 cm), flexible tube at end of which is a mini video camera, which enables the user to inspect the lining of the stomach and a ??snare?? to take samples of tissue (biopsies). YF476 is a gastrin antagonist (blocks the effects of gastrin), so it??s a potential new medical treatment for gastric carcinoids in patients with CAG. Up to 10 of these patients will take YF476 for up to 12 weeks. They??ll make up to seven outpatient visits for tests, including checks on the safety of YF476 and up to four gastroscopies. At each gastroscopy, the gastric carcinoids will be measured and biopsies taken for laboratory tests. Patients will take up to 24 weeks to finish the study.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  10/H0304/51

• Date of REC Opinion

  7 Jul 2010

• REC opinion

  Further Information Favourable Opinion