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    Summary
    EudraCT Number:2015-002983-18
    Sponsor's Protocol Code Number:ICT-8
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-07-31
    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 ConcernedSpain - AEMPS
    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
    Estudio de eficacia de inecalcitol en combinación con decitabina en pacientes con leucemia mieloide aguda no aptos para quimioterapia estándar
    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
    Estudio de eficacia de inecalcitol en combinación con decitabina en pacientes con leucemia mieloide aguda no aptos para quimioterapia estándar
    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 organisationDynamic
    B.5.2Functional name of contact pointDepartamento de Ensayos Clínicos
    B.5.3 Address:
    B.5.3.1Street AddressAzcona, 31
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28028
    B.5.3.4CountrySpain
    B.5.4Telephone number+34914561105
    B.5.5Fax number+34914561126
    B.5.6E-mailensayosclinicos@dynasolutions.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.3.8 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 codeTX522
    D.3.9.3Other descriptive nameINECALCITOL
    D.3.9.4EV Substance CodeSUB33672
    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
    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
    Leucemia mieloide aguda
    E.1.1.1Medical condition in easily understood language
    Acute Myeloid Leukemia
    Leucemia mieloide aguda
    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.
    Evaluar el efecto de añadir inecalcitol al tratamiento con decitabina en la
    supervivencia global de pacientes con leucemia mieloide aguda previamente no
    tratados, de 65 años o más, aleatoriamente seleccionados para recibir decitabina
    con o sin inecalcitol.
    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
    Evaluar:
    - La respuesta completa
    - La supervivencia libre de evento y la supervivencia libre de recaída entre
    grupos de tratamiento
    - La incidencia y la gravedad de la toxicidad
    - La incidencia de episodios infecciosos
    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.
    •Pacientes de entre 65 a < 75 años con al menos una comorbilidad no severa, por ejemplo enfermedad o síndrome con observaciones de leves a moderadas clínicas o de diagnóstico, o anomalías de laboratorio que pudieran aumentar el riesgo de toxicidad y/o muerte prematura por quimioterapia intensiva según la opinión del investigador y que no están contraindicados para una quimioterapia no intensiva (en la sección 5.3 se exponen ejemplos).
    o ≥ 75 años con o sin ninguna comorbilidad en el momento de la firma del consentimiento informado;
    •Leucemia mieloide aguda de reciente diagnóstico, no tratada de novo o secundaria según la clasificación de la OMS;
    •Los hombres fértiles aceptan la práctica de una anticoncepción eficaz durante el estudio y durante los tres meses siguientes a la interrupción del tratamiento;
    •Los pacientes aceptan cumplir los requisitos del estudio y acudir a la clínica para las visitas que exige el estudio;
    •Los pacientes aceptan seguir las restricciones de medicación durante el estudio;
    •Los pacientes han firmado un consentimiento informado escrito.
    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.
    •Tratamiento previo o actual con quimioterapia para cualquier trastorno mieloide (salvo hidroxiurea) o con radioterapia para afecciones extramedulares en las dos semanas previas a la aleatorización;
    •Tratamiento previo con decitabina, azacitidina o citarabina;
    •Neoplasias previas durante 5 años con excepción de carcinoma de células basales o escamosas de la piel, o carcinoma "in situ" de la cérvix o de mama;
    •Leucemia mieloide crónica o leucemia promielocítica aguda;
    •Afección conocida del sistema nervioso central;
    •Paciente apto para trasplante de médula ósea o de célula madre;
    •Recuento de leucocitos ≥ 30.000/mm3;
    •Insuficiencia renal con aclaramiento de creatinina < 30 mL/min/1,73m² según la fórmula de Modificación de Dieta en la Enfermedad Renal;
    •Bilirrubina sérica ≥ 2,5 x límite superior normal y/o transaminasas AST y/o ALT ≥ 2,5 x límite superior normal;
    •Calcemia ≥ 2,65 mmol/L (106 mg/L) en la evaluación de la vista de selección (corregida con albuminemia);
    •Antecedentes de enfermedades conocidas por su asociación con trastornos del calcio: hiperparatiroidismo en curso, sarcoidosis;
    •Presencia o antecedentes de cálculos renales sintomáticos en los últimos 5 años;
    •Hipersensibilidad a algunos de los excipientes de la decitabina (dihidrogenofosfato de potasio (E340); hidróxido sódico (E524); ácido clorhídrico (para ajuste del pH) o al excipiente de los comprimidos de inecalcitol (lactosa);
    •Consumo actual de medicamentos conocidos por influir en el calcio sérico (como los diuréticos tiazídicos, la teriparatida, la calcitonina y los suplementos multivitamínicos con > 400 unidades internacionales de vitamina D o calcio);
    •Consumo actual de digitalis;
    •Consumo actual de medicamentos que podrían influir en la biodisponibilidad del inecalcitol (antiácidos con magnesio, resinas secuestradoras);
    •Consumo de cualquier otro medicamento o terapia experimental o suplementos de vitamina D en las 4 semanas previas a la aleatorización;
    •VIH conocido;
    •Pacientes aptos para terapia de inducción intensiva con intención curativa;
    •Insuficiencia cardíaca congestiva refractaria;
    •Infección activa resistente a tratamiento antiinfeccioso;
    •Enfermedad pulmonar documentada con capacidad de difusión (DLCO) ≤ 65%, o volumen máximo de aire espirado en el primer segundo (FEV1) ≤ 65%, o disnea en reposo o que requiera oxígeno, o cualquier neoplasia pleural o neoplasia pulmonar no controlada;
    •Cirrosis hepática Child-Pugh B o C, o hepatitis viral aguda;
    •Enfermedad mental actual que requiera hospitalización psiquiátrica, internamiento o tratamiento intensivo ambulatorio, o estado cognitivo actual que produzca dependencia (confirmada por especialistas) no controlada por el cuidador;
    •Neoplasia no controlada.
    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
    Supervivencia global definida como el periodo comprendido entre la aleatorización y la fecha de muerte por cualquier causa
    E.5.1.1Timepoint(s) of evaluation of this end point
    Each time during the study.
    A lo largo de todo el estudio
    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.
    Eficacia:
    - Proporción de pacientes que obtienen una respuesta completa compuesta según las recomendaciones del Grupo de Trabajo Internacional (IWG 2003), incluyendo CRi/CRp;
    - Supervivencia libre de evento definida como el periodo comprendido entre la aleatorización y la fecha de fallo del tratamiento, recaída o muerte por cualquier causa, lo primero que suceda.
    - La supervivencia libre de recaída sólo se define para pacientes que consiguen
    una remisión completa. Se define como el intervalo desde la primera fecha en que se documente el estado sin leucemia hasta la fecha de fallo del tratamiento, recaída o muerte por cualquier causa, lo primero que suceda.

    Seguridad:
    - Incidencia y características de todos los acontecimientos adversos y acontecimientos adversos graves según valoración clínica y de laboratorio conforme a la escala de criterios de toxicidad NCI/CTC AE, versión 4.0.
    - Incidencia, gravedad, duración y tiempo hasta que se produce la hipercalcemia.
    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.
    - Eficacia : tras 3 y 6 ciclos de tratamiento
    - Seguridad : de forma continua desde la firma del consentimiento informado y hasta 4 semanas tras la última dosis de tratamiento de estudio.
    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
    Belgium
    France
    Germany
    Spain
    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
    UVUP
    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 months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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 state7
    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 per the standard of care.
    Tratamiento según la práctica clínica habitual.
    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 Decision2017-09-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-31
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-10-23
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