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    Summary
    EudraCT Number:2015-002983-18
    Sponsor's Protocol Code Number:ICT-8
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-03-02
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2015-002983-18
    A.3Full title of the trial
    Efficacy Study of Inecalcitol in Combination with Decitabine in Acute Myeloid Leukemia Patients Unfit for Standard Chemotherapy
    Etude évaluant l’efficacité de l’inécalcitol en combinaison avec la décitabine chez les patients âgés de 65 ans et plus atteints d’une leucémie aiguë myéloïde nouvellement diagnostiquée et non candidats à une chimiothérapie d'induction standard
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy Study of Inecalcitol in Combination with Decitabine in Acute Myeloid Leukemia Patients Unfit for Standard Chemotherapy
    Etude évaluant l’efficacité de l’inécalcitol en combinaison avec la décitabine chez les patients âgés de 65 ans et plus atteints d’une leucémie aiguë myéloïde nouvellement diagnostiquée et non candidats à une chimiothérapie d'induction standard
    A.3.2Name or abbreviated title of the trial where available
    ICT-8
    ICT-8
    A.4.1Sponsor's protocol code numberICT-8
    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 SponsorHybrigenics S.A.
    B.1.3.4CountryFrance
    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 supportHybrigenics
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHybrigenics S.A.
    B.5.2Functional name of contact pointJean-François
    B.5.3 Address:
    B.5.3.1Street AddressDufour-Lamartinie
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75014
    B.5.3.4CountryFrance
    B.5.4Telephone number+33158103805/08
    B.5.5Fax number+33158103840
    B.5.6E-mailjfdufour@hybrigenics.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/3/15/1523
    D.3 Description of the IMP
    D.3.1Product nameinecalcitol
    D.3.2Product code HBX 34,701
    D.3.4Pharmaceutical form Tablet
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    Acute Myeloid Leukemia
    Leucémie Aigüe Myéloïde
    E.1.1.1Medical condition in easily understood language
    Acute Myeloid Leukemia
    Leucémie Aigüe Myéloïde
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10000886
    E.1.2Term Acute myeloid leukemia
    E.1.2System Organ Class 100000012984
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of the addition of inecalcitol to decitabine treatment on overall survival in previously untreated AML patients 65 years or more who are randomly assigned to receive decitabine with or without inecalcitol.
    Evaluer l'effet sur la survie globale de l'ajout de l'inécalcitol au traitement par decitabine chez des patients non traités âgés de 65 ans et plus, atteints d’une leucémie aiguë myéloïde.
    E.2.2Secondary objectives of the trial
    To evaluate:
    - Complete response
    - Event-free and relapse-free survival between treatment arms
    - Incidence and severity of toxicities
    - Incidence of infectious episodes
    Evaluer:
    - la réponse complète
    - la survie sans évènement et sans rechute entre les 2 bras de traitement
    - l'incidence et la sévérité des toxicités
    - l'incidence des épisodes infectieux
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Patients aged 65 to < 75 years with at least one non severe comorbidity ie disease or syndrome with mild to moderate clinical or diagnostic observations or lab abnormalities which could increase the risk of toxicity and/or early death of intensive chemotherapy in the opinion of the investigator and are not contra-indicated for non-intensive chemotherapy. (examples provided in section 5.3)
    or ≥ 75 years with or without any comorbidity at the time of the informed consent signature;
    •Newly diagnosed, untreated de novo or secondary AML according to WHO classification;
    •Fertile men agree to practice effective contraception during the study and for 3 months following treatment discontinuation;
    •Patients agree to comply with the study requirements and agrees to come to the clinic for required study visits;
    •Patients agree to follow medication restrictions during the study;
    •Patients have signed written informed consent.
    •Hommes ou femmes âgés de 65 à moins de 75 ans avec au moins une comorbidité non sévère (c’est-à-dire une maladie ou un syndrome avec des manifestations cliniques ou biologiques modérées qui, d’après l’investigateur, pourraient augmenter le risque de toxicité et/ou de décès prématuré d’une chimiothérapie intensive et ne sont pas contre-indiqués pour une chimiothérapie non-intensive (Cf exemples en section 5.3 du protocole)
    Ou patient âgé de 75 ou plus avec ou sans comorbidité associée au moment de la signature du consentement éclairé.
    •Leucémie aigüe myéloïde de novo ou secondaire non-traitée, nouvellement diagnostiquée selon la classification WHO ;
    •Les hommes en âge de procréer acceptent de pratiquer une contraception efficace durant l’étude et pendant les trois mois suivant l’arrêt du traitement.
    •Les patients acceptent de se conformer aux requis de l’étude et de venir à l’hôpital pour les visites requises par le protocole.
    •Les patients acceptent de se conformer aux restrictions médicamenteuses durant l’étude.
    •Les patients ont signé un consentement éclairé.
    E.4Principal exclusion criteria
    •Prior or current treatment with chemotherapy for any myeloid disorder (excluding hydroxyurea) or radiotherapy for extramedullary involvement within 2 weeks of randomization;
    •Prior treatment with decitabine, azacitidine, or cytarabine;
    •Chronic myelogenous or acute promyelocytic leukaemia;
    •Prior malignancies for 5 years with exception of basal cell, squamous cell carcinoma of the skin, or carcinoma « in situ » of the cervix or breast;
    •Known CNS involvement;
    •Patient eligible to bone marrow or stem cell transplant;
    •WBC ≥ 30.000/mm3;
    •Impaired renal function with Creatinine clearance < 30 mL/min/1.73m², according to the MDRD formula;
    •Serum bilirubin ≥ 2.5 x ULN and/or AST and/or ALT ≥ 2.5 x ULN (upper limit of normal value);
    •Calcemia ≥ 2.65 mmol/L (106 mg/L) at screening assessment (corrected with albuminemia);
    •History of diseases known to be associated with calcium disorders: ongoing hyperparathyroidism, sarcoidosis….;
    •Presence or history of symptomatic kidney stones in the last 5 years;
    •Hypersensitivity to any of the excipients of decitabine (Potassium dihydrogen phosphate (E340) ; Sodium hydroxide (E524) ; Hydrochloric acid (for pH adjustment) or to the excipient of inecalcitol tablets (lactose);
    •Current use of drugs known to influence serum calcium (such as thiazide diuretics, teriparatide, calcitonin and multivitamin supplements containing > 400 IU of vitamin D or calcium);
    •Current use of digitalis;
    •Current use of drugs which could influence bioavailability of inecalcitol (such as magnesium-containing antacids, bile-resin binders);
    •Use of any other experimental drug or therapy or vitamin D supplementation within 4 weeks of randomization;
    •Known HIV;
    •Patients who are eligible for intensive induction therapy with curative intent;
    •Refractory congestive heart failure;
    •Active infection resistant to anti-infective therapy;
    •Documented pulmonary disease with DLCO ≤ 65% or FEV1 ≤ 65%, or dyspnea at rest or requiring oxygen, or any pleural neoplasm or uncontrolled lung neoplasm;
    • Liver cirrhosis Child B or C or acute viral hepatitis;
    • Current mental illness requiring psychiatric hospitalization, institutionalization or intensive outpatient management, or current cognitive status that produces dependence (as confirmed by the specialist) not controlled by the caregiver;
    • Uncontrolled neoplasia.
    •Précédent traitement ou traitement en cours par chimiothérapie pour des atteintes myéloïdes (à l’exclusion de l’hydroxyurée) ou radiothérapie pour une atteinte extra médullaire dans les 2 semaines précédant la randomisation;
    •Antécédents de traitement par décitabine, azacitidine ou cytarabine ;
    •Leucémie myéloïde chronique ou leucémie aigüe promyélocytaire ;
    •Antécédent d’un autre cancer dans les 5 ans à l’exception de cancer basocellulaire, de carcinome des cellules squameuses de la peau ou de carcinome « in situ » du col de l’utérus ou du sein ;
    •Patient éligible à une transplantation de cellules souches de moelle osseuse;
    •Atteinte du système nerveux central connue ;
    •Globules blancs ≥ 30.000/mm3 ;
    •Fonction rénale diminuée avec une clairance de créatinine < 30 mL/min/1,73m² selon la formule MDRD ;
    •Bilirubine sérique ≥ 2.5 x LSN et/ou ASAT et/ou ALAT ≥ 2.5 x LSN (limite supérieure normale) ;
    •Calcium ≥ 2,65 mmol/l (106 mg/L) à l’évaluation du screening (corrigée par l’albuminémie) ;
    •Antécédent de maladie connue pour entraîner des anomalies du métabolisme phosphocalcique : hyperparathyroïdie en cours, sarcoïdose, … ;
    •Présence ou antécédent de lithiase rénale symptomatique dans les 5 ans ;
    •Hypersensibilité aux excipients de la decitabine (phosphate de potassium (E340), hydroxide de sodium (E524), acide chlorydrique (pour l’ajustement du pH) ou aux excipients des comprimés d’inécalcitol (lactose) ;
    •Traitement en cours par des médicaments connus pour modifier le taux de calcium sérique (tels que les diurétiques thiazidiques, le tériparatide, la calcitonine, les suppléments multi-vitaminiques contenant > 400 UI de vitamine D ou du calcium) ;
    •Traitement en cours par digitaliques ;
    •Traitement en cours par des médicaments susceptibles de modifier la biodisponibilité de l’inécalcitol (tels que les antiacides à base de magnésium, les chélateurs à base de résines)
    •Utilisation d’un traitement ou thérapie expérimental ou supplémentation en vitamine D dans les 4 semaines précédant la randomisation ;
    •VIH connu ;
    •Patients éligibles à une thérapie d’induction intensive à visée curative ;
    •Insuffisance cardiaque congestive réfractaire ;
    •Infection active résistante aux thérapies anti-infectieuses ;
    •Maladie pulmonaire documentée avec DLCO ≤ 65% ou FEV1 ≤ 65%, ou dyspnée au repos ou requérant de l’oxygène, ou néoplasme pleural ou néoplasme pulmonaire non-contrôlé ;
    •Cirrhose du foie Child B ou C ou hépatite virale aigue ;
    •Maladie mentale en cours nécessitant une hospitalisation en psychiatrie, un internement ou un suivi intensif en consultation externe, ou un état cognitif de dépendance (confirmé par un spécialiste) non-contrôlé par le personnel soignant ;
    •Néoplasie non contrôlée.
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival defined as the time from randomization to the date of death for any cause
    Survie globale définie comme le temps entre la randomisation et la date de décès quelle qu’en soit la cause.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Each time during the study.
    A tout moment au cours de l'étude.
    E.5.2Secondary end point(s)
    Efficacy:
    - Proportion of patients who obtain composite CR according to IWG 2003 recommendations including CRi/CRp;
    - Event-free survival defined as the time from the date of randomization to the date of treatment failure, relapse or death from any cause, whichever occurs first.
    - Relapse-free survival is defined only for patients achieving a complete remission. It is defined as the interval from the date of first documentation of leukemia-free state to the date of treatment failure, relapse or death from any cause whichever occurs first

    Safety:
    - Incidence and characteristics of all AE(s) and SAE(s) from clinical and laboratory assessment according to the NCI/CTC AE version 4.0 scale.
    - Incidence, severity, duration and time to occurrence of hypercalcemia.
    Efficacité :
    - Proportion de patients obtenant une rémission complète composite incluant réponse complète en absence de normalisation de la numération sanguine ou des plaquettes (CRi/CRp);
    - Survie sans évènement définie par le temps entre la date de randomisation et la date de première documentation d’échec au traitement, de rechute ou de décès quelle qu’en soit la cause ;
    - Survie sans rechute uniquement pour les patients obtenant une rémission complète définie par le temps entre la date de première documentation du statut sans leucémie et la date de première documentation d’échec au traitement, de rechute ou de décès quelle qu’en soit la cause.

    Tolérance:
    - Caractéristiques et incidence des EI(s) et EIG(s) de l’évaluation clinique et biologique selon l’échelle du NCI/CTC AE version 4.0 ;
    - Incidence, sévérité, durée et délai d’apparition des hypercalcémies.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Efficacy : after 3 and 6 cycles of treatment
    - Safety : continuously from informed consent form signature and up to 4 weeks after the last IMP intake.
    - Efficacité : après 3 et 6 cycles de traitement
    - Tolérance : en continu depuis la signature du consentement et jusqu'à 4 semaines après la dernière prise d'inécalcitol.
    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 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 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 Yes
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    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 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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 110
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 110
    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)
    Treatment according to investigator choice as no treatment is marketed for this group of patients.
    Selon l'appréciation de l'investigateur car il n'y a pas de traitement sur le marché pour cette population de patients.
    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 Decision2017-04-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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