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    Summary
    EudraCT Number:2014-004347-12
    Sponsor's Protocol Code Number:ICT-10
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-06-19
    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 ConcernedFrance - ANSM
    A.2EudraCT number2014-004347-12
    A.3Full title of the trial
    Exploratory Study of Inecalcitol in Imatinib-Treated
    Residual Chronic Myeloid Leukaemia: INIM Study
    Etude exploratoire de l'inécalcitol dans la maladie résiduelle de la leucémie myéloïde chronique traitée par imatinib - étude INIM
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Exploratory Study of Inecalcitol in Imatinib-Treated
    Residual Chronic Myeloid Leukaemia: INIM Study
    Etude exploratoire de l'inécalcitol dans la maladie résiduelle de la leucémie myéloïde chronique traitée par imatinib - étude INIM
    A.3.2Name or abbreviated title of the trial where available
    INIM study
    étude INIM
    A.4.1Sponsor's protocol code numberICT-10
    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 SA
    B.1.3.4CountryFrance
    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 supportHybrigenics SA
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHybrigenics SA
    B.5.2Functional name of contact pointJean-François Dufour-Lamartinie
    B.5.3 Address:
    B.5.3.1Street Address3-5 impasse Reille
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75014
    B.5.3.4CountryFrance
    B.5.4Telephone number33158103805/08
    B.5.5Fax number33158103840
    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 No
    D.2.5.1Orphan drug designation number
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNinecalcitol
    D.3.9.1CAS number 163217-09-2
    D.3.9.2Current sponsor codeHBX 34,701
    D.3.9.3Other descriptive nameTX522
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    Residual disease in Chronic Myeloid Leukaemia
    E.1.1.1Medical condition in easily understood language
    Residual disease in Chronic Myeloid Leukaemia
    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 18.0
    E.1.2Level LLT
    E.1.2Classification code 10009015
    E.1.2Term Chronic myeloid leukemia
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of inecalcitol in combination with imatinib in chronic myeloid leukaemia patients with molecular residual disease on imatinib monotherapy.
    E.2.2Secondary objectives of the trial
    To determine:
    - duration of response
    - progression free survival
    - proportion of responders during inecalcitol treatment and 2 years after discontinuation of inecalcitol and imatinib
    - bone remodeling effect
    - safety of inecalcitol in combination with imatinib
    - quality of life
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Men or women aged of at least 18 years at the time of informed consent signature;
    • Patients have signed written informed consent;
    • ECOG performance status < 2;
    • Patients with Philadelphia chromosome positive chronic phase CML and M BCR-ABL transcript positivity (e13a2 ou e14a2);
    • Treatment with imatinib for more than 2 years (a history of treatment with interferon is tolerated);
    • Patient in complete cytogenetic response with BCR-ABL/ABL status between 0.1% International Scale (IS) and 0.01% IS and no BCR-ABL checkpoint in the last six months better than Molecular Response MR4 (i.e. BCR-ABL ratio < 0.01% IS);
    • Women of child bearing potential have a negative pregnancy test prior to first dose and agree to practice effective contraception during the study;
    • Fertile men agree to practice effective contraception during the study;
    • Patients agree to comply with the study requirements and agree to come to the clinic for required study visits;
    • Patients agree to follow medication restrictions during the study;
    E.4Principal exclusion criteria
    • Expression of unusual BCR-ABL transcripts (other than e13a2 or e14a2)
    Pregnant or lactating women;
    • Participating in another clinical trial with any investigative drug within 30 days prior to study enrolment(except from OPTIM imatinib);
    • Treatment with interferon within the last 24 months;
    • Imatinib dose modification within the last 3 months;
    • Prior history of haematopoietic stem cell transplantation;
    • Impaired renal function with creatinine clearance < 30 ml/min/1.73m² according to the MDRD formula;
    • Hypercalcemia (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;
    • Current use of drugs known to influence serum calcium (such as thiazide diuretics, teriparatide, bisphosphonates, and 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);
    • Patients with a chronic condition which is not well controlled that, according to the investigator, would interfere with the completion of the study;
    • Use of any other experimental drug, therapy or vitamin D supplementation within 30 days of first inecalcitol administration;
    • Patients with a mental deficiency preventing proper understanding of trial protocol requirements;
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of responders defined as patients achieving at least MR4.5 (i.e. detectable disease ≤ 0.0032 % BCR-ABL IS or undetectable disease with cDNA with ≥32,000 ABL1 transcripts) at any time within 12 months after the initiation of inecalcitol.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 6 months and then at least every 3 months or every month for patient achieving MR4,5.
    E.5.2Secondary end point(s)
    - Efficacy:
    • Duration of the response evaluated by BCR-ABL/ABL ratio;
    • Progression free survival defined as the time from the date of first inecalcitol treatment dose until the date of the first documentation of progressive disease or death;
    • Proportion of responders 2 years after inecalcitol discontinuation evaluated by BCR-ABL/ABL ratio;
    • Duration of response after inecalcitol and imatinib discontinuation evaluated by BCR-ABL/ABL ratio performed every 3 months;
    • Bone remodeling by measurement of C-telopeptide, osteocalcin, calcitonin and PTH every 3 months during inecalcitol treatment period;
    • Quality of life evaluated by EORTC QLQ-CX24 questionnaire every 6 months during the study;

    - 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;
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Efficacy : at 6 months and every 3 months afterwards
    - Safety : continuously from informed consent form signature and up to 4 weeks after the last IMP intake.
    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 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 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 concerned5
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months2
    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: 54
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 54
    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 state54
    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 international recommandation such as the European LeukemiaNet.
    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 Decision2014-12-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-04-30
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