YF476 and Type I Gastric Carcinoids (Norway)

Chronic Atrophic Gastritis Clinical Trial

Official title:

A Single Centre, Pilot Trial of YF476 in Patients With Chronic Atrophic Gastritis, Hypergastrinaemia and Type I Gastric Carcinoids

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01444014
• Other study ID #: T-015
• Secondary ID: 2010-023151-28
• Status: Terminated
• Phase: Phase 2
• First received: September 28, 2011
• Last updated: May 14, 2015
• Start date: June 2011
• Est. completion date: May 2012

Study information

• Verified date: May 2015
• Source: Trio Medicines Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 oophorectomy, 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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrophy
• Carcinoid Tumor
• Chronic Atrophic Gastritis
• Gastritis
• Gastritis, Atrophic
• Hypergastrinemia
• Type I Gastric Carcinoids

Intervention

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.

Locations

Country	Name	City	State
Norway	Institutt for kreftforskning og molekylaer medisin	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Trio Medicines Ltd.	Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual assessment of the number of gastric carcinoids.		2 years	No
Primary	Visual assessment of the size of gastric carcinoids		2 years	No
Primary	Visual assessment of the distribution of gastric carcinoids.		2 years	No
Secondary	Safety and tolerability of YF476, as judged by medical examinations, vital signs, ECG, safety tests of blood and urine, and adverse events.		2 years	Yes
Secondary	Histologic grading of biopsies.		2 years	No
Secondary	Plasma concentrations of YF476.		2 years	No
Secondary	Plasma or serum concentrations of biomarkers such as gastrin and chromogranin A (CgA)		2 years	No