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YF476 and Type I Gastric Carcinoids

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ClinicalTrials.gov Identifier: NCT01339169
Recruitment Status : Completed
First Posted : April 20, 2011
Last Update Posted : August 19, 2019
Sponsor:
Collaborator:
Royal Liverpool University Hospital
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. If they benefit from that treatment, they may take YF476 daily for up to another 52 weeks. They'll make several outpatient visits for tests, including checks on the safety of YF476. At some of the visits, they'll have a gastroscopy. At each gastroscopy, the gastric carcinoids will be measured and biopsies taken for laboratory tests.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
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
Actual Study Start Date : January 4, 2011
Actual Primary Completion Date : December 10, 2013
Actual Study Completion Date : December 10, 2013


Arm Intervention/treatment
Experimental: YF476 treatment 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. After that, patients that have benefited from treatment may take 50 mg YF476 once daily for an additional up to 52 weeks.
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 or chromogranin A (CgA). [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 oophrectomy, 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 ClinicalTrials.gov identifier (NCT number): NCT01339169


Locations
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United Kingdom
Royal Liverpool University Hospital
Liverpool, United Kingdom, L7 8XP
Sponsors and Collaborators
Trio Medicines Ltd.
Royal Liverpool University Hospital
Investigators
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Study Director: Malcolm Boyce, BSc FRCP FFPM Trio Medicines Ltd.
Principal Investigator: Mark Pritchard, PhD FRCP Royal Liverpool University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Trio Medicines Ltd.
ClinicalTrials.gov Identifier: NCT01339169    
Other Study ID Numbers: T-008
2007-002916-24 ( EudraCT Number )
First Posted: April 20, 2011    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019
Keywords provided by Trio Medicines Ltd.:
YF476
Hypergastrinaemia
netazepide
gastric carcinoids
Additional relevant MeSH terms:
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Carcinoid Tumor
Gastritis
Gastritis, Atrophic
Atrophy
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Pathological Conditions, Anatomical
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases