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YF476 and Type II Gastric Carcinoids

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Disease Information

Descriptive Information
Brief Title † YF476 and Type II Gastric Carcinoids
Official Title † A Pilot Trial of YF476, a Gastrin Antagonist, in Patients With Type II Gastric Carcinoids Associated With Zollinger-Ellison Syndrome
Brief Summary 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.
Detailed Description
Study Phase Phase 2
Study Type † Interventional
Study Design † Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary Outcome Measure † Regression of gastric carcinoids and/or ECL cell hyperplasia defined by physical measurements taken during endoscopy
Secondary Outcome Measure † Improvement in histological grade of gastric carcinoids/ECL cell hyperplasia defined by physical measurements taken during endoscopy
Condition † Zollinger-Ellison Syndrome
Intervention † DrugYF476
Study Arms / Comparison Groups 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.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 30
Start Date † April 2011
Completion Date January 2024
Primary Completion Date January 2024
Eligibility Criteria † Inclusion criteria: 1. Men; post-menopausal women; pre-menopausal women who have been sterilised by tubal ligation, hysterectomy or bilateral oophorectomy; or pre-menopausal women using one of the allowed methods of contraception: condom and spermicide or intra-uterine device. 2. Patients with serum gastrin >250 pg/mL. 3. Hepatic function: AST and ALT ≤2.0 x ULN; total bilirubin ≤1.0 x ULN. 4. Renal function: serum creatinine 6 months with stable or worsening carcinoids. 6. Inability to tolerate endoscopy, or refusal of endoscopy. 7. Physical findings, ECG (especially prolonged QTc interval >450 msec), or laboratory values at the pre-trial screening assessment that could interfere with the objectives of the trial or the safety of the subject. 8. Certain medicines and herbal remedies taken during the 7 days before visit 2. 9. Participation in a trial of an IMP within the previous 28 days. 10. Presence of drug or alcohol abuse. 11. History or baseline findings of: - type 1 diabetes mellitus; - pancreatitis (baseline amylase and/or >2.0 x ULN); - hepatitis B, hepatitis C or HIV; - malabsorption syndrome or inability to swallow or retain oral medicine; - major surgery 2; or - another cancer within 3 years except for basal carcinoma of the skin or cervical carcinoma in-situ. - Also, any clinically significant and uncontrolled major morbidity including but not limited to; serious cardiac disease (unstable angina, s/p myocardial infarction
Gender Both
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries †
Administrative Information
NCT ID † NCT02454075
Organization ID T-010
Secondary IDs †† 11-DK-0114
Responsible Party Sponsor
Study Sponsor † Trio Medicines Ltd.
Collaborators †† National Institutes of Health (NIH)
Investigators † : ,
Information Provided By
Verification Date May 2015
First Received Date † May 13, 2015
Last Updated Date May 21, 2015
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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