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    Summary
    EudraCT Number:2007-002916-24
    Sponsor's Protocol Code Number:T-008
    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:2010-06-21
    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 number2007-002916-24
    A.3Full title of the trial
    A single centre, pilot trial of YF476 in patients with chronic atrophic gastritis, hypergastrinaemia and type I gastric carcinoids
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pilot trial of YF476 in patients with gastric carcinoids
    A.3.2Name or abbreviated title of the trial where available
    YF476 and type I gastric carcinoids
    A.4.1Sponsor's protocol code numberT-008
    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.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTrio Medicines Ltd
    B.5.2Functional name of contact pointTrio Clinical Trial Info Desk
    B.5.3 Address:
    B.5.3.1Street AddressPO Box 53346
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeNW10 7XU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number004402089638708
    B.5.5Fax number004402089638665
    B.5.6E-mailtrioclintrials@hmrlondon.com
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/07/452
    D.3 Description of the IMP
    D.3.1Product nameYF476
    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 INNYF476
    D.3.9.1CAS number 155488-25-8
    D.3.9.2Current sponsor codeYF476
    D.3.9.3Other descriptive nameN/A
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Type I gastric carcinoids, chronic atrophic gastritis and hypergastrinaemia.
    E.1.1.1Medical condition in easily understood language
    These patients make antibodies that damage the stomach. This leads to a high level of gastrin, which makes certain cells in the stomach grow and, with time, turn into tumours (gastric carcinoids).
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10060377
    E.1.2Term Hypergastrinaemia
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10003685
    E.1.2Term Atrophic gastritis
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10017769
    E.1.2Term Gastric carcinoid
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To find out if YF476 is an effective medical treatment for type I gastric carcinoids.



    E.2.2Secondary objectives of the trial
    To find out if YF476 has any important side effects in patients with type I gastric carcinoids.

    To find out if YF476 affects biomarkers of ECL cell activity.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    We include patients who meet the following criteria.

    *Patients known to have gastric carcinoids associated with chronic atrophic gastritis and hypergastrinaemia, and who attend the out-patient clinic of the investigators;

    *Men, post-menopausal women, pre-menopausal women who have been sterilised by tubal ligation, hysterectomy or bilateral oophrectomy, or pre-menopausal women using reliable contraception: condom and spermicide or intra-uterine device;

    *Adults ≥ 18 years;

    *Good general health; and

    *Able to give fully-informed, written consent.
    E.4Principal exclusion criteria
    We exclude participants who meet the following 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 (see protocol);

    *Previous treatment with somatostatin; or

    *Participation in other clinical trials of unlicensed medicines within the previous 3 months.
    E.5 End points
    E.5.1Primary end point(s)
    Visual assessment of the number, size and distribution of gastric carcinoids.

    E.5.1.1Timepoint(s) of evaluation of this end point
    Visual assessment of the number, size and distribution of gastric carcinoids is carried out at 6 and 12 weeks after starting the initial 12 weeks' treatment; and at 24 and 52 weeks after starting the extended dosing period.
    E.5.2Secondary end point(s)
    Effect of YF476 on biomarkers.

    Safety and tolerability of long-term treatment with YF476.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Biomarker assessments after 3, 6, 9, and 12 weeks after starting the initial 12 weeks' treatment; and 12, 24, 36, and 52 weeks after starting the extended dosing period.

    Assessment of adverse events and safety tests of blood and urine after 3, 6, 9, and 12 weeks after starting the initial 12 weeks' treatment; and 12, 24, 36, and 52 weeks after starting the extended dosing period.
    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 Yes
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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.8.5The 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 No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    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 trial will end when the last subject has had their last visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 10
    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)
    The investigator will inform patients before they consent to take part in the study that they will not be able to continue YF476 after the end of the study unless there is evidence that YF476 eradicates their gastric carcinoids, in which case the sponsor would amend the protocol and seek approval for treatment with a low maintenance dose of YF476 of 10–25 mg daily. If the patient's gastric carcinoids are still present at the end of the study, there are alternative medical or surgical treatments.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2010-07-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-07-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-01-27
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