Pilot trial of YF476 in patients with gastric carcinoids

Phase 1

• Conditions: Type I gastric carcinoids, chronic atrophic gastritis and hypergastrinaemia.; MedDRA version: 14.1Level: PTClassification code 10060377Term: HypergastrinaemiaSystem Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 14.1Level: LLTClassification code 10003685Term: Atrophic gastritisSystem Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 14.1Level: LLTClassification code 10017769Term: Gastric carcinoidSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2007-002916-24-GB
• Lead Sponsor: Trio Medicines Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-21
• Last Update Posted: 11 May 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

We include patients who meet the following criteria.

*Patients known to have gastric carcinoids associated with chronic atrophic gastritis and hypergastrinaemia, and who attend the out-patient clinic of the investigators;

*Men, post-menopausal women, pre-menopausal women who have been sterilised by tubal ligation, hysterectomy or bilateral oophrectomy, or pre-menopausal women using reliable contraception: condom and spermicide or intra-uterine device;

*Adults = 18 years;

*Good general health; and

*Able to give fully-informed, written consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

We exclude participants who meet the following 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 (see protocol);

*Previous treatment with somatostatin; or

*Participation in other clinical trials of unlicensed medicines within the previous 3 months.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To find out if YF476 is an effective medical treatment for type I gastric carcinoids.<br><br><br><br> ;Secondary Objective: To find out if YF476 has any important side effects in patients with type I gastric carcinoids.<br><br>To find out if YF476 affects biomarkers of ECL cell activity.;Primary end point(s): Visual assessment of the number, size and distribution of gastric carcinoids.<br> <br>;Timepoint(s) of evaluation of this end point: Visual assessment of the number, size and distribution of gastric carcinoids is carried out at 6 and 12 weeks after starting the initial 12 weeks' treatment; and at 24 and 52 weeks after starting the extended dosing period.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Effect of YF476 on biomarkers.<br><br>Safety and tolerability of long-term treatment with YF476.;Timepoint(s) of evaluation of this end point: Biomarker assessments after 3, 6, 9, and 12 weeks after starting the initial 12 weeks' treatment; and 12, 24, 36, and 52 weeks after starting the extended dosing period.<br><br>Assessment of adverse events and safety tests of blood and urine after 3, 6, 9, and 12 weeks after starting the initial 12 weeks' treatment; and 12, 24, 36, and 52 weeks after starting the extended dosing period.