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    Summary
    EudraCT Number:2013-003183-31
    Sponsor's Protocol Code Number:DSC/13/2984/05
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-06-22
    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 ConcernedFrance - ANSM
    A.2EudraCT number2013-003183-31
    A.3Full title of the trial
    A Randomized, Multicenter, Phase II study to Investigate Efficacy and Safety of ITF2984 in Acromegalic patients.
    Étude de phase II, randomisée et multicentrique, visant à étudier l’efficacité et la sécurité d’emploi du ITF2984 chez des patients atteints d’acromégalie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Acromegalia
    acromégalie
    A.4.1Sponsor's protocol code numberDSC/13/2984/05
    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 SponsorITALFARMACO S.p.A.
    B.1.3.4CountryItaly
    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 supportITALFARMACO S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationITALFARMACO S.p.A.
    B.5.2Functional name of contact pointClinical Scientist
    B.5.3 Address:
    B.5.3.1Street AddressVia dei Lavoratori, 54
    B.5.3.2Town/ cityCinisello Balsamo (MI)
    B.5.3.3Post code20092
    B.5.3.4CountryItaly
    B.5.4Telephone number+390264432521
    B.5.5Fax number+390264433554
    B.5.6E-mails.manzoni@italfarmaco.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameITF2984 diacetate
    D.3.2Product code ITF2984
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.9.3Other descriptive nameITF2984
    D.3.9.4EV Substance CodeSUB33237
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number500 to 2000
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Octreotide
    D.2.1.1.2Name of the Marketing Authorisation holderChemi S.p.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameOCTREOTIDE
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous 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
    Acromegaly
    Acromegalie
    E.1.1.1Medical condition in easily understood language
    Acromegaly
    Acromegalie
    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
    To investigate the effect of treatment on GH and IGF-1 concentrations.
    Étudier l’effet du traitement sur les concentrations de GH et d’IGF-1
    E.2.2Secondary objectives of the trial
    - To investigate the biochemical response of ITF2984, defined as a reduction in (random) GH < 1.0 mcg/l and/or normalization of IGF-1.
    - To investigate the biochemical response of ITF2984, defined as a reduction of GH to no more than 2.5 mcg/l and/or normalization of IGF-1.
    - To evaluate variation of signs and symptoms of acromegaly at the end of each month of treatment in comparison with basal status.
    - To investigate the pharmacokinetic (PK) profile of ITF2984 and Octreotide
    - To compare the effects on GH and IGF1 circulating levels of different doses of ITF2984
    - To compare the effects on GH and IGF1 circulating levels of ITF2984 and Octreotide
     Étudier la réponse biochimique du ITF2984, définie comme une diminution du taux (mesuré de façon aléatoire) de GH jusqu'à < 1,0 μg /l et/ou la normalisation du taux d’IGF-1.
    - Étudier la réponse biochimique du ITF2984, définie comme une diminution du taux de GH jusqu’à un taux ne dépassant pas 2,5 μg /l et/ou la normalisation du taux d’IGF-1.
    - Évaluer les modifications des signes et symptômes de l’acromégalie à la fin de chaque mois de traitement par rapport à l’examen initial.
    - Évaluer le profil pharmacocinétique (PK) du ITF2984 et de l’octréotide.
    - Comparer les effets des différentes doses de ITF2984 sur les taux de GH et d’IGF-1 en circulation
    - Comparer les effets du ITF2984 et de l’octréotide sur les taux de GH et d’IGF-1 en circulation
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Signed written informed consent.
    - Patients with active acromegaly due to a pituitary adenoma. Active acromegaly should be confirmed by 2h five point mean GH level higher than 5 mcg/liter, lack of suppression of GH nadir to less than 1 mcg/liter after oral glucose tolerance test, and elevated IGF-1 for age and sex-matched controls.
    - Patients aged between 18 to 80 years old inclusive.
    - Patients treated with previous surgery and/or medical therapy or previously untreated (de novo). For patients who had previously received medical therapy for acromegaly a washout periods before study entry of 3 months for long-acting formulation of somatostatin analogs and 2 weeks for octreotide sc must be foreseen. Partial responder means a significant decrease (>50%), without achievement of control of GH and/or IGF-1 levels and/or >20 % tumor shrinkage after at least 6 months of SRL therapy.
    - Patients with GH level and IGF-1 level for age and sex-matched controls out of range at baseline.
    - Consentement éclairé signé
    - Patients présentant une acromégalie active en raison d’un adénome hypophysaire. L’acromégalie active doit être confirmée par un taux moyen de GH mesuré par cinq points à 2 heures supérieur à 5 μg /l, une absence de freinage d’un nadir de GH à moins de 1 μg /litre après une épreuve d’hyperglycémie provoquée par voie orale, et un taux élevé d’IGF-1 par rapport aux sujets témoins de même âge et de même sexe.
    - Patients âgés de 18 à 80 ans (inclus).
    - Patients ayant déjà subi une chirurgie et/ou un traitement médical ou n’ayant jamais été précédemment traités (de novo). Pour les patients ayant précédemment reçu un traitement médical pour l’acromégalie, une période de sevrage de 3 mois pour un traitement par des analogues de la somatostatine à action prolongée, et de 2 semaines pour l’octréotide par voie s.c., doit être observée avant l’inclusion dans l’étude. Une réponse partielle est définie par une diminution significative (> 50 %), sans parvenir au contrôle des taux de GH et/ou d’IGF-1, et/ou une diminution tumorale > 20 % après au moins 6 mois de traitement par des ligands des récepteurs de la somatostatine.
    - Patients présentant des taux de GH et d’IGF-1 en dehors des limites des valeurs de référence au même âge et pour un même sexe lors de la visite de référence.
    E.4Principal exclusion criteria
    - Patients undergone pituitary surgery within the prior 6 months.
    - Patients who have received pituitary radiotherapy (within last 10 years).
    - Patients with compression of the optic chiasm causing any visual field defect.
    - Patients who require a surgical intervention for relief of any sign or symptom associated with tumor compression.
    - Patients with uncontrolled diabetes defined as having a fasting glucose > 150 mg/dL (8.3 mmol/L) or HbA1c ? 8% (Patients can be rescreened after diabetes is brought under adequate control).
    - Patients with significant cardiovascular morbidity within the three months preceding enrollment.
    - Symptomatic cholelithiasis, gallstone or chronic liver disease.
    - Clinically significant GI, renal or hepatic disease (in the opinion of investigator).
    - AST and/or ALT>2ULN.
    - Active HBV and/or active HCV infection.
    - Patients who have a history of alcohol or drug abuse in the six-month period prior to the enrollment visit.
    - Known hypothyroidism or hypocortisolism not adequately treated with a stable dose of thyroid or steroid hormone replacement therapy for at least the previous 3 months.
    - Known hypersensitivity to any of the study medications, or components thereof or a history of drug or other allergy that in the opinion of the Investigator contraindicates their participation.
    - Female patients who are pregnant or lactating, and female patient who are of childbearing potential or male patient with female partners of childbearing potential who do not accept the contraception requirements reported in the protocol.
    - Patients who have participated in any clinical investigation with an Investigational drug within 3 months before study entry.
    - Current or recent (< 2 months) therapy with pegvisomant or cabergoline.
    - Patients ayant subi une chirurgie de l’hypophyse au cours des 6 derniers mois.
    - Patients ayant reçu une radiothérapie hypophysaire (au cours de ces 10 dernières années)
    - Patients présentant une compression du chiasma optique entraînant une altération du champ visuel.
    - Patients chez qui une intervention chirurgicale est nécessaire pour soulager tout signe ou symptôme associé à une compression tumorale.
    - Patients présentant un diabète non contrôlé défini par une glycémie à jeun > 150 mg/dl (8,3 mmol/l) ou un taux de HbA1c ≥ 8 % (les patients peuvent être re-sélectionnés une fois que leur diabète est correctement contrôlé).
    - Patients ayant présenté une maladie cardiovasculaire significative au cours des trois mois précédant l’inclusion.
    - Lithiase biliaire symptomatique, calculs biliaires ou maladie hépatique chronique.
    - Maladie gastro-intestinale, rénale ou hépatique cliniquement significative (selon l’avis de l’investigateur).
    - ASAT et/ou ALAT > 2 LNS.
    - Infection active par le VHB et/ou le VHC.
    - Patients présentant des antécédents d’alcoolisme ou de toxicomanie au cours des 6 mois précédant la visite d’inclusion.
    - Hyperthyroïdie ou Hypocortisolisme connu(e) et insuffisamment contrôlé(e) par un traitement hormonal substitutif thyroïdien ou stéroïdien à dose stable au moins au cours des 3 derniers mois
    - Hypersensibilité connue à l’un des médicaments à l’étude ou à leurs composants, et antécédents d’allergie médicamenteuse ou de tout autre type d’allergie qui, de l’avis de l’investigateur, constituerait une contre-indication à la participation.
    - Patientes enceintes ou qui allaitent, et patientes en âge de procréer ou patients de sexe masculin ayant une partenaire en âge de procréer refusant les exigences en matière de contraception indiquées dans le protocole.
    - Patients ayant participé à une autre étude clinique sur un produit expérimental au cours des 3 mois précédant l’inclusion à l’étude.
    - Traitement en cours ou récent (< 2 mois) par pegvisomant ou cabergoline.

    E.5 End points
    E.5.1Primary end point(s)
    - Change of GH and/or IGF-1 levels at the end of each month of treatment.
    - Modification des taux de GH et/ou d’IGF-1 à la fin de chaque mois de traitement.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of each month of treatment
    à la fin de chaque mois de traitement
    E.5.2Secondary end point(s)
    - Number and percentage of patients with reduction of GH < 1.0 mcg/l and/or normalization of IGF-1 at the end of each month of treatment.
    - Number and percentage of patients with reduction in GH <2.5 mcg/l and/or normalization of IGF-1 at the end of each month of treatment.
    - Number and percentage of patients with improvement of signs and symptoms of acromegaly at the end of each month of treatment.
    - Nombre et pourcentage de patients présentant une diminution du taux de GH à < 1,0 mcg/l et/ou normalisation du taux d’IGF-1 à la fin de chaque mois de traitement.
    - Nombre et pourcentage de patients présentant une diminution du taux de GH à < 2,5 mcg/l et/ou normalisation du taux d’IGF-1 à la fin de chaque mois de traitement.
    - Nombre et pourcentage de patients présentant une amélioration des signes et des symptômes de l’acromégalie à la fin de chaque mois de traitement.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of each month of treatment
    à la fin de chaque mois de traitement
    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 Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    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
    LVLS
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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)
    None
    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 Decision2014-11-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-02-08
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