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    Summary
    EudraCT Number:2013-002063-26
    Sponsor's Protocol Code Number:METYX01
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-07-23
    Trial 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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-002063-26
    A.3Full title of the trial
    A prospective open-label Phase 2 study of METYRAPONE as a preoperative treatment in patients with ACTH-independent Cushing’s syndrome due to adrenal adenoma.
    Studio prospettico in aperto di fase II per valutare l’effetto di metopirone come trattamento preoperatorio in pazienti affetti da sindrome di Cushing ACTH-indipendente da adenoma surrenalico.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial with Metyrapone in Cushing's syndrome
    Trial clinico con Metopirone nella sindrome di Cushing
    A.3.2Name or abbreviated title of the trial where available
    METYX01
    METYX01
    A.4.1Sponsor's protocol code numberMETYX01
    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 SponsorS.C.D.U. MEDICINA INTERNA 1 Ospedale San Luigi Orbassano
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportHRA Pharma
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationS.C.D.U. MEDICINA INTERNA 1 Ospedale San Luigi Orbassano
    B.5.2Functional name of contact pointStudy Coordinator
    B.5.3 Address:
    B.5.3.1Street AddressRegione Gonzole 10
    B.5.3.2Town/ cityOrbassano
    B.5.3.3Post code10043
    B.5.3.4CountryItaly
    B.5.4Telephone number00390119026513
    B.5.5Fax number00390116705456
    B.5.6E-mailoncotrial.sanluigi@gmail.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 Yes
    D.2.1.1.1Trade name Matyrapone
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratorie HRA Pharma, Paris
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 nameMetyrapone
    D.3.2Product code Metyrapone
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    Cushing's syndrome
    Malattia di Cushing
    E.1.1.1Medical condition in easily understood language
    Cushing's disease
    Malattia di Cushing
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to assess the efficacy of METYRAPONE in attaining normalization of 24-h urinary free cortisol (UFC) excretion or a ≥50% decrease from baseline using the mean of 2 UFC measurements within 3 months of treatment.
    Valutare l’efficacia del metopirone (alla dose iniziale di 250 mg t.i.d. con successivi aggiustamenti posologici in tempi prefissati), nell’ottenere una normalizzazione della cortisoluria o una riduzione > 50% rispetto ai valori basali usando la media di 2 determinazioni di cortisolo urinario (CLU) nell’arco di 3 mesi di trattamento
    E.2.2Secondary objectives of the trial
    • time to response
    • dose-response relationship
    • effect of METYRAPONE on levels of serum cortisol, UFC, salivary cortisol, ACTH, 11-deoxicortisol, deoxycorticosterone, total testosterone, androstenedione, DHEA-S in terms of percent variation relative to baseline.
    • improvement of the clinical signs associated to hypercortisolism (blood pressure, body mass index, waist)
    • Valutare il tempo alla risposta.
    • Valutare la risposta in relazione alla dose.
    • Valutare l’effetto di metopirone sui livelli di cortisolo sierico, CLU, cortisolo salivare, ACTH,11-desossicortisolo, desossicorticosterone, testosterone totale, DHEAS, Androstenedione, in termini di variazione percentuale rispetto al basale.
    • Valutare il miglioramento dei segni clinici associati a ipercortisolismo: pressione arteriosa, indice di massa corporea, circonferenza vita.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    no sub-study exist
    non esistono sottostudi
    E.3Principal inclusion criteria
    Both sexes and age≥ 18 years

    - Confirmed diagnosis of ACTH-independent Cushing’s syndrome validated by all the following criteria:
    • two 24 h urinary collections for UFC at least 1.5 times the upper normal value, within 2 weeks prior to enrollment.
    • levels of serum ACTH lower than the normal range
    • CT-confirmed diagnosis of adrenal adenoma (size 2-4 cm, regular shape and margins, homogeneous density <10 HU). Unenhanced adrenal CT scan should be performed within 4 weeks prior to enrollment.
    • Adrenalectomy planned.


    - ECOG performance status ≤ 2
    • Entrambi i sessi ed età ≥ 18 anni
    • Diagnosi confermata di sindrome di Cushing ACTH-indipendente sostenuta da un adenoma surrenalico, comprovata da
    - Livelli di cortisolo libero urinario delle 24 ore superiori a 1.5 il limite superiore del range di normalità del laboratorio, in almeno due raccolte delle 24 ore, effettuate entro due settimane prima dell’arruolamento
    - ACTH plasmatico del mattino inferiore al range di normalità
    - Conferma alla TC surrenalica di adenoma surrenalico (diametro compreso tra 2-4 cm, con margini e forma regolari, densità omogenea inferiore alle 10 HU)
    - Pianificazione dell’ intervento di surrenectomia
    • ECOG performance status < 2
    E.4Principal exclusion criteria
    Patients who meet any of the following exclusion criteria are not eligible for enrollment.

    - Prior metyrapone therapy

    - Mitotane therapy within 6 months prior entering the study (mitotane levels should be undetectable prior to enrollment)

    - Cushing’s syndrome with ACTH levels that are not clearly suppressed

    - Hypercortisolism due to an adrenal tumor of uncertain dignity (suspicious for malignancy)
    • Precedente terapia con metopirone
    • Terapia con mitotano nei 6 mesi precedenti
    • Sindrome di Cushing con livelli di ACTH non chiaramente soppressi
    • Ipercortisolismo secondario a tumore surrenalico sospetto per malignità
    E.5 End points
    E.5.1Primary end point(s)
    Primary
    All patients will be included in the efficacy analysis. The primary efficacy variable is UFC.
    • Tutti i pazienti saranno inclusi nell’analisi di efficacia. La variabile primaria di efficacia è il CLU.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months
    3 mesi
    E.5.2Secondary end point(s)
    The secondary efficacy variables include other hormones (including serum and salivary cortisol levels), laboratory tests, and clinical signs and symptoms.
    Le variabili secondarie di efficacia includono altre valutazioni ormonali tra cui, cortisolo sierico e salivare, valutazioni di laboratorio e segni e sintomi clinici
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 months
    3 mesi
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    The aim of the study is to improve patient’s conditions in preparation to adrenalectomy through control of cortisol excess and its attendant complications.
    Lo scopo dello studio consiste nel migliorare le condizioni dei pazienti con sindrome di Cushing da adenoma surrenalico per prepararli al meglio all'intervento di surrenalectomia, controllando e riducendo la secrezione di cortisolo
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned8
    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 No
    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
    last visit of last subject
    ultima visita ultimo paziente arruolato
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 10
    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 No
    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 state15
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 15
    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)
    no plans
    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 Decision2013-09-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-12
    P. End of Trial
    P.End of Trial StatusOngoing
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