YF476 and Type II Gastric Carcinoids
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ClinicalTrials.gov Identifier: NCT02454075 |
Recruitment Status
:
Enrolling by invitation
First Posted
: May 27, 2015
Last Update Posted
: October 18, 2017
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Sponsor:
Trio Medicines Ltd.
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Trio Medicines Ltd.
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Zollinger-Ellison Syndrome | Drug: YF476 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
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 |
Study Start Date : | April 2011 |
Estimated Primary Completion Date : | January 2024 |
Estimated Study Completion Date : | January 2024 |
Resource links provided by the National Library of Medicine

MedlinePlus related topics:
Carcinoid Tumors
Genetic and Rare Diseases Information Center resources:
Carcinoid Tumor
Zollinger-Ellison Syndrome
Neuroendocrine Tumor
Neuroepithelioma
U.S. FDA Resources
Arm | Intervention/treatment |
---|---|
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.
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Drug: YF476
Gastrin receptor antagonist
Other Name: Netazepide
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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.
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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- 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.
- Patients with serum gastrin >250 pg/mL.
- Hepatic function: AST and ALT ≤2.0 x ULN; total bilirubin ≤1.0 x ULN.
- Renal function: serum creatinine <1.0 x ULN.
- Haematologic function: Hb ≥10.0 g/dL; WBC ≥3.5 x 10e9 /L; ANC ≥1.5 x 10e9 /L; platelets ≥100 x 10e9 /L.
- Coagulation parameters: INR or PT ≤1.0 x ULN; PTT ≤1.0 x ULN.
- Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire trial.
- Willingness to give fully-informed, written consent.
Exclusion criteria:
- Patients under 18 years.
- Women who are pregnant, lactating or using a steroid contraceptive.
- Prior gastric resection or bypass.
- Planned gastrinoma resection during the study period.
- Patients on somatostatin analogues, except for those on therapy for >6 months with stable or worsening carcinoids.
- Inability to tolerate endoscopy, or refusal of endoscopy.
- 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.
- Certain medicines and herbal remedies taken during the 7 days before visit 2.
- Participation in a trial of an IMP within the previous 28 days.
- Presence of drug or alcohol abuse.
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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 <28 days prior to enrolment;
- ECOG performance staus >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 <1 month); respiratory disease (advanced COPD or pulmonary fibrosis); uncontrolled hypertension; or active systemic infection.
No Contacts or Locations Provided
Responsible Party: | Trio Medicines Ltd. |
ClinicalTrials.gov Identifier: | NCT02454075 History of Changes |
Obsolete Identifiers: | NCT01322542 |
Other Study ID Numbers: |
T-010 11-DK-0114 ( Other Identifier: NIH number ) |
First Posted: | May 27, 2015 Key Record Dates |
Last Update Posted: | October 18, 2017 |
Last Verified: | October 2017 |
Keywords provided by Trio Medicines Ltd.:
YF476 netazepide gastric carcinoids Zollinger-Ellison syndrome |
Additional relevant MeSH terms:
Syndrome Carcinoid Tumor Zollinger-Ellison Syndrome Gastrinoma Disease Pathologic Processes Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
Paraneoplastic Endocrine Syndromes Paraneoplastic Syndromes Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Peptic Ulcer Duodenal Diseases Intestinal Diseases Stomach Diseases Carcinoma, Islet Cell Pancreatic Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Pancreatic Diseases |