NCT01444014

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 30, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

May 15, 2015

Status Verified

May 1, 2015

Enrollment Period

11 months

First QC Date

September 28, 2011

Last Update Submit

May 14, 2015

Conditions

Chronic Atrophic GastritisHypergastrinemiaType I Gastric Carcinoids

Keywords

YF476netazepidehypergastrinaemiagastric carcinoids

Outcome Measures

Primary Outcomes (3)

  • Visual assessment of the number of gastric carcinoids.

    2 years

  • Visual assessment of the size of gastric carcinoids

    2 years

  • Visual assessment of the distribution of gastric carcinoids.

    2 years

Secondary Outcomes (4)

  • Safety and tolerability of YF476, as judged by medical examinations, vital signs, ECG, safety tests of blood and urine, and adverse events.

    2 years

  • Histologic grading of biopsies.

    2 years

  • Plasma concentrations of YF476.

    2 years

  • Plasma or serum concentrations of biomarkers such as gastrin and chromogranin A (CgA)

    2 years

Study Arms (1)

YF476

EXPERIMENTAL
Drug: YF476

Interventions

YF476DRUG

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.

Also known as: netazepide
YF476

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institutt for kreftforskning og molekylaer medisin

Trondheim, Norway

Location

MeSH Terms

Conditions

Gastritis, Atrophic

Interventions

YF 476

Condition Hierarchy (Ancestors)

GastritisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Study Officials

  • Helge Waldum, MD PhD

    St Olav's Hospital/NTNU

    PRINCIPAL INVESTIGATOR

  • Malcolm Boyce, BSc FRCP FFPM

    Trio Medicines Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2011

First Posted

September 30, 2011

Study Start

June 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

May 15, 2015

Record last verified: 2015-05

Locations

NO(1)