Overview

This trial is active, not recruiting.

Conditions chronic atrophic gastritis, hypergastrinaemia, type i gastric carcinoids
Treatment yf476
Phase phase 2
Sponsor Trio Medicines Ltd.
Collaborator Royal Liverpool University Hospital
Start date January 2011
End date July 2017
Trial size 10 participants
Trial identifier NCT01339169, 2007-002916-24, T-008

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 (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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
yf476 netazepide
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.

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients known to have gastric carcinoids associated with chronic atrophic gastritis and hypergastrinaemia, and who attend the outpatient clinic of the investigator; - Men, postmenopausal women, premenopausal women who have been sterilised by tubal ligation, hysterectomy or bilateral oophrectomy, or premenopausal women using reliable contraception: condom and spermicide or intrauterine device; - Adults ≥ 18 years; - Good general health; and - Able to give fully-informed, written consent. Exclusion Criteria: - Women who are pregnant, lactating or using a steroid contraceptive; - History of gastric surgery, apart from surgery for gastric carcinoids; - Evidence of Zollinger-Ellison syndrome; - Prolonged QTc interval (>450 msec); - Certain medicines and herbal remedies taken during the 7 days before visit 1; - Previous treatment with somatostatin; or - Participation in other clinical trials of unlicensed medicines within the previous 3 months.

Additional Information

Official title A Single Centre, Pilot Trial of YF476 in Patients With Chronic Atrophic Gastritis, Hypergastrinaemia and Type I Gastric Carcinoids
Principal investigator Mark Pritchard, PhD FRCP
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Trio Medicines Ltd..