YF476 and Type II Gastric Carcinoids
This study is enrolling participants by invitation only.
Trio Medicines Ltd.
First Posted: May 27, 2015
Last Update Posted: October 18, 2017
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Trio Medicines Ltd.
This study will evaluate whether treatment with YF476 is safe and effective in reducing the size of type II gastric carcinoid tumours, or limiting the abnormal growth of gastric ECL cells, in patients with Zollinger-Ellison syndrome.
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Pilot Trial of YF476, a Gastrin Antagonist, in Patients With Type II Gastric Carcinoids Associated With Zollinger-Ellison Syndrome|
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources: Carcinoid Tumor Zollinger-Ellison Syndrome NeuroepitheliomaU.S. FDA Resources
Further study details as provided by Trio Medicines Ltd.:
Primary Outcome Measures:
- Regression of gastric carcinoids and/or ECL cell hyperplasia defined by physical measurements taken during endoscopy [ Time Frame: Up to 10 years ]Regression is defined as a 25% reduction in the size / number of endoscopically evident type II gastric carcinoids; or a reduction of 25% in the gastric ECL cell density.
Secondary Outcome Measures:
- Improvement in histological grade of gastric carcinoids/ECL cell hyperplasia defined by physical measurements taken during endoscopy [ Time Frame: Up to 10 years ]Reduction in the histological grade of the carcinoids/hyperplasia when compared to baseline.
- Level of gastrin and chromogranin A (CgA) biomarkers measured in blood samples [ Time Frame: Up to 10 years ]Reduction in the levels of circulating gastrin and CgA biomarkers.
- Control of gastric acid secretion assessed by changes in drug-controlled gastric acid analysis (acid control study) [ Time Frame: Up to 10 years ]Assessed by changes in drug-controlled gastric acid analysis.
- Decrease in ECL cell-specific products assessed by quantitative PCR [ Time Frame: Up to 10 years ]Assessed by quantitiative PCR.
- Improvement in reflux/dyspepsia symptoms using the GERD-HRQL instrument [ Time Frame: Up to 10 years ]Assessed by the GERD-HRQL instrument.
- Safety and tolerability by monitoring adverse events [ Time Frame: Up to 10 years ]The treatment is safe and well tolerated when added to existing treatments for ZES.
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||January 2024|
|Estimated Primary Completion Date:||January 2024 (Final data collection date for primary outcome measure)|
Experimental: Eligible patients
The dose will be 100 mg YF476 once daily. When 6 patients have completed 12 weeks' treatment with that dose, it may be increased to 150 or 200 mg once daily. Patients will have type II gastric carcinoids and/or ECL cell hyperplasia/dysplasia.
Gastrin receptor antagonist
Other Name: Netazepide
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