YF476 and Type I Gastric Carcinoids

Trio Medicines

Status and phase: Completed; Phase 2

Conditions: Hypergastrinaemia; Chronic Atrophic Gastritis; Type I Gastric Carcinoids

Treatments: Drug: YF476

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01339169

2007-002916-24 (EudraCT Number)

T-008

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

YF476 treatment

Experimental group

Treatment:

Drug: YF476