YF476 and Type I Gastric Carcinoids (Norway)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Norwegian University of Science and Technology
Information provided by (Responsible Party):
Trio Medicines Ltd.
ClinicalTrials.gov Identifier:
NCT01444014
First received: September 28, 2011
Last updated: NA
Last verified: September 2011
History: No changes posted
  Purpose

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 is a gastrin 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 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 Intervention Phase
Chronic Atrophic Gastritis
Hypergastrinaemia
Type I Gastric Carcinoids
Drug: YF476
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Trio Medicines Ltd.:

Primary Outcome Measures:
  • Visual assessment of the number of gastric carcinoids. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Visual assessment of the size of gastric carcinoids [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Visual assessment of the distribution of gastric carcinoids. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Histologic grading of biopsies. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Plasma concentrations of YF476. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: June 2011
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01444014

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

No publications provided

Responsible Party: Trio Medicines Ltd.
ClinicalTrials.gov Identifier: NCT01444014     History of Changes
Other Study ID Numbers: T-015
Study First Received: September 28, 2011
Last Updated: September 28, 2011
Health Authority: Norway: Norwegian Medicines Agency

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

ClinicalTrials.gov processed this record on October 21, 2014