A Phase 2 interventional study of YF476 in Chronic Atrophic Gastritis, Hypergastrinaemia and Type I Gastric Carcinoids, sponsored by Trio Medicines Ltd.. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-19.
Sponsored by Trio Medicines Ltd. · Phase 2, Interventional, and Treatment
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 (netazepide) is a gastrin receptor 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 daily for up to 12 weeks. If they benefit from that treatment, they may take YF476 daily for up to another 52 weeks. They'll make several outpatient visits for tests, including checks on the safety of YF476. At some of the visits, they'll have a gastroscopy. At each gastroscopy, the gastric carcinoids will be measured and biopsies taken for laboratory tests.
152 studies on the registry are indexed under Carcinoid Tumor; 16 are open to participants now.
This study's enrollment of 8 is below the median of 36 across 106 interventional studies indexed under Carcinoid Tumor.
Browse Carcinoid Tumor studies →Trio Medicines Ltd. is the lead sponsor of 14 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Drug: YF476
50 mg once daily for 12 weeks, with the option to increase to 75 mg or 100 mg once daily after 6 weeks, or decrease to 25 mg once daily, depending on response. After that, patients that have benefited from treatment may take 50 mg YF476 once daily for an additional up to 52 weeks.
Also known as: netazepide
Visual assessment of the number of gastric carcinoids.
Time frame: 2 years
Visual assessment of the size of gastric carcinoids.
Time frame: 2 Years
Visual assessment of the distribution of gastric carcinoids.
Time frame: 2 years
Safety and tolerability of YF476, as judged by medical examinations, vital signs, ECG, safety tests of blood and urine, and adverse events.
Time frame: 2 years
Histologic grading of biopsies.
Time frame: 2 years
Plasma concentrations of YF476.
Time frame: 2 years
Plasma or serum concentrations of biomarkers such as gastrin or chromogranin A (CgA).
Time frame: 2 years
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Trio Medicines Ltd.