YF476 and Type I Gastric Carcinoids (Norway)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01444014
Recruitment Status : Terminated (Difficulties with recruitment)
First Posted : September 30, 2011
Last Update Posted : May 15, 2015
Norwegian University of Science and Technology
Information provided by (Responsible Party):
Trio Medicines Ltd.

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.

Condition or disease Intervention/treatment Phase
Chronic Atrophic Gastritis Hypergastrinemia Type I Gastric Carcinoids Drug: YF476 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Centre, Pilot Trial of YF476 in Patients With Chronic Atrophic Gastritis, Hypergastrinaemia and Type I Gastric Carcinoids
Study Start Date : June 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Arm Intervention/treatment
Experimental: YF476 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.
Other Name: netazepide

Primary Outcome Measures :
  1. Visual assessment of the number of gastric carcinoids. [ Time Frame: 2 years ]
  2. Visual assessment of the size of gastric carcinoids [ Time Frame: 2 years ]
  3. Visual assessment of the distribution of gastric carcinoids. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. 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 ]
  2. Histologic grading of biopsies. [ Time Frame: 2 years ]
  3. Plasma concentrations of YF476. [ Time Frame: 2 years ]
  4. Plasma or serum concentrations of biomarkers such as gastrin and chromogranin A (CgA) [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01444014

Institutt for kreftforskning og molekylaer medisin
Trondheim, Norway
Sponsors and Collaborators
Trio Medicines Ltd.
Norwegian University of Science and Technology
Principal Investigator: Helge Waldum, MD PhD St Olav's Hospital/NTNU
Study Director: Malcolm Boyce, BSc FRCP FFPM Trio Medicines Ltd.

Responsible Party: Trio Medicines Ltd. Identifier: NCT01444014     History of Changes
Other Study ID Numbers: T-015
2010-023151-28 ( EudraCT Number )
First Posted: September 30, 2011    Key Record Dates
Last Update Posted: May 15, 2015
Last Verified: May 2015

Keywords provided by Trio Medicines Ltd.:
gastric carcinoids

Additional relevant MeSH terms:
Carcinoid Tumor
Gastritis, Atrophic
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Pathological Conditions, Anatomical
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases