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    Summary
    EudraCT Number:2014-002418-22
    Sponsor's Protocol Code Number:T-016
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-04-16
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2014-002418-22
    A.3Full title of the trial
    Randomized, placebo-controlled trial of YF476, a gastrin receptor antagonist, in Barrett’s esophagus (10-505; T-016)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Netazepide (YF476) in patients with Barrett's oesophagus
    A.3.2Name or abbreviated title of the trial where available
    Netazepide (YF476) in patients with Barrett's oesophagus; version 1
    A.4.1Sponsor's protocol code numberT-016
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01298999
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTrio Medicines Ltd
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportTrio Medicines Ltd
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportColumbia University
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportCambridge University Hospital NHS Foundation Trust
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNetazepide (YF476)
    D.3.2Product code YF476
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNetazepide
    D.3.9.1CAS number 155488-25-8
    D.3.9.2Current sponsor codeYF476
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Barrett's oesophagus
    E.1.1.1Medical condition in easily understood language
    Damage and changes to the tissue lining the foodpipe
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10004137
    E.1.2Term Barrett's oesophagus
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level HLT
    E.1.2Classification code 10052778
    E.1.2Term Gastrointestinal mucosal dystrophies and secretion disorders
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level HLGT
    E.1.2Classification code 10017943
    E.1.2Term Gastrointestinal conditions NEC
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level SOC
    E.1.2Classification code 10017947
    E.1.2Term Gastrointestinal disorders
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To find out if YF476 decreases the levels of Ki67, a substance (biomarker) that indicates cellular growth and activity, in patients with Barrett's oesophagus.
    E.2.2Secondary objectives of the trial
    To assess the effect of YF476 on the levels of substances (biomarkers) linked to:
    • cancer of the oesophagus
    • the homone gastrin and its effects

    We also aim to find out if YF476 is safe in patients with Barrett’s oesophagus.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    BO patients, aged 18 years of age; histologically confirmed diagnosis of Barrett's oesophagus, without dysplasia; have taken a proton pump inhibitor (PPI) use at least once daily, for the past 12 months, and a stable dose of PPI for the past 3 months; otherwise in good health; up-to-date with all age-appropriate cancer screening tests and no cancer screening planned for the next 21 weeks; able to communicate with study personnel; reliable, willing, and likely to comply with the protocol; and willing to comply with the contraception requirements of the protocol, and consent to our informing their GP of their participation in the study.
    E.4Principal exclusion criteria
    We exclude participants who meet the following criteria:

    * histologically confirmed Barrett's oesophagus (BO) with dysplasia or cancer of the oesophagus; clinically relevant ECG findings; history of allergic reactions to medicines similar to YF476; have taken part in another clinical trial of an experimental medicine within the past 28 days; have taken certain medicines or herbal remedies during the 7 days before the start of the study; have a history of or baseline findings indicative of medical conditions related to gastrin, or medical conditions or procedures related to the gastro-intestinal system; have had any cancer (except non-invasive skin or cervical cancer) in the past 3 years; have had any other clinically significant disease — because they might increase the risk or confound the assessment of YF476; or

    * pregnant or breastfeeding; unwilling to comply with the contraception requirements of the protocol — because of the potential risk to the unborn or breastfed baby.

    Those criteria are designed to select patients with BO who are otherwise healthy and robust enough to recover quickly from any adverse effects of YF476.
    E.5 End points
    E.5.1Primary end point(s)
    Expression of Ki67 (a biomarker of cell growth and activity) in BO biopsies.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At baseline and at 12 weeks.
    E.5.2Secondary end point(s)
    Expression of CCK2R, DCAMKL1, COX-2 and p53 (biomarkers associated with oesophageal cancer).
    Plasma levels of CgA (that indicates how well the effect of gastrin is blocked).
    Serum gastrin levels (a marker of how well gastrin is blocked).
    Assessment of adverse events (to assess YF476 safety in patients).
    Changes in histology (what the cells look like) from tissue of the oesophagus.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Expression of CCK2R, DCAMKL1, COX-2 and p53: at baseline and at 12 weeks.
    Plasma levels of CgA: at baseline, at 6 and 12 weeks and at follow-up.
    Serum gastrin levels: at baseline, at 6 and 12 weeks and at follow-up.
    Assessment of adverse events: at 6 and 12 weeks and at follow-up.
    Changes in histology: at baseline and at 12 weeks.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the trial is defined as the last visit of the last subject, or completion of bioanalysis, whichever is later.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days17
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 11
    F.4.2.2In the whole clinical trial 22
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    If the results of the completed trial show that treatment with YF476 is beneficial to patients with BO, the investigators might seek permission from Cambridge University Hospitals (CUH) NHS Foundation Trust to treat patients, on a named patient basis, with YF476.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-10-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-10-10
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