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    Summary
    EudraCT Number:2014-003065-15
    Sponsor's Protocol Code Number:WO29519
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-01-11
    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 number2014-003065-15
    A.3Full title of the trial
    A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PHASE III STUDY OF IDASANUTLIN, AN MDM2 ANTAGONIST, WITH CYTARABINE VERSUS CYTARABINE PLUS PLACEBO IN PATIENTS WITH RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML).
    ENSAYO DE FASE III, MULTICÉNTRICO, DOBLE CIEGO, ALEATORIZADO, CONTROLADO CON PLACEBO, DE IDASANUTLIN, UN ANTAGONISTA DE MDM2, CON CITARABINA FRENTE A
    CITARABINA MÁS PLACEBO EN PACIENTES CON LEUCEMIA MIELOIDE AGUDA (LMA) EN RECAÍDA O REFRACTARIA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Idasanutlin with Cytarabine versus Cytarabine plus Placebo in Patients with Relapsed or Refractory Acute Myeloid Leukemia.
    Ensayo de Idasanutlin con Citarabina frente a Citarabina mas placebo en pacientes con Leucemia Mieloide Aguda en recaida o refractaria.
    A.4.1Sponsor's protocol code numberWO29519
    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 SponsorRoche Farma, S.A., que representa en España a F. Hoffmann-La Roche Ltd.
    B.1.3.4CountrySwitzerland
    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 supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+3491325 73 00
    B.5.6E-mailglobal.rochegenentechtrials@roche.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/3/14/1328
    D.3 Description of the IMP
    D.3.1Product nameidasanutlin
    D.3.2Product code RO5503781/F13-01
    D.3.4Pharmaceutical form Film-coated 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 INNidasanutlin
    D.3.9.1CAS number 1229705-06-9
    D.3.9.2Current sponsor codeRO5503781
    D.3.9.4EV Substance CodeSUB167603
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 CYTARABINE
    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 nameCytarabine
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCYTARABINE
    D.3.9.1CAS number 147-94-4
    D.3.9.4EV Substance CodeSUB06880MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 placeboFilm-coated tablet
    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
    Relapsed or refractory acute myeloid leukemia.
    Leucemia mieloide aguda en recaída o refractaria
    E.1.1.1Medical condition in easily understood language
    Acute myeloid leukemia (AML) is a type of cancer that starts in the blood-forming cells of the bone marrow, characterised by an over-production of immature white blood cells.
    La leucemia mieloide aguda (LMA) es un tipo de cancer que comienza en las células precursoras de sangre de la medula espinal, caracterizado por una sobreproducción de globulos blancos inmaduros
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10000886
    E.1.2Term Acute 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
    Within the TP53 wild-type population:
    ? To compare overall survival (OS) in patients with relapsed or refractory AML who have been randomized to idasanutlin in combination with cytarabine versus those who have been randomized to cytarabine and placebo.
    En la población con TP53 no mutado:
    ? Comparar la supervivencia global (SG) entre los pacientes con leucemia mieloide aguda
    (LMA) en recaída o refractaria que hayan sido aleatorizados a recibir idasanutlin en
    combinación con citarabina y los que lo hayan sido a recibir citarabina y placebo.
    E.2.2Secondary objectives of the trial
    Within the all-patient population
    ? To compare OS in patients with relapsed or refractory AML who have been randomized to idasanutlin in combination with cytarabine versus those who have been randomized to cytarabine and placebo.
    Within the all-patient population and the TP53 wild-type population
    ? To compare
    - the proportions of complete remission (CR), and CR with incomplete platelet count recovery (CRp) between treatment arms
    - the proportions of overall remissions (CR, CRp, CR with incomplete blood count recovery [Cri]) between treatment arms
    - event-free survival (EFS) and leukemia-free survival (LFS) between treatment arms
    - the proportions of allogeneic hematopoietic stem cell transplant (HSCT) following response between treatment arms
    - the differences in disease and treatment related symptoms and health related quality of life
    ? To assess the safety between treatment arms
    ? To characterize the pharmacokinetics of both idasanutlin and cytarabine.
    Población de todos los pacientes
    ? Comparar la SG de los pacientes con LMA en recaída o refractaria entre los grupos de tratamiento
    En la población de todos los pacientes y la población con TP53 no mutado
    ? Comparar
    -Las proporciones de remisiones completas (RC) y remisiones completas con recuperaciones incompletas del recuento de plaquetas (RCp) entre los grupos de tratamiento.
    - Las proporciones de remisiones globales (RC, RCp, RC con
    recuperación incompleta del hemograma [RCi]) entre los grupos de tratamiento.
    -La supervivencia sin eventos (SSE) y sin leucemia (SSL) entre los grupos de tratamiento.
    - Las proporciones de alotrasplantes de células madre hematopoyéticas (alo-
    TCMH) tras la respuesta entre los grupos de tratamiento.
    -Las diferencias en cuanto a sintomas relacionados con el tratamiento y enfermedad y la calidad de vida relacionada con salud
    ? Para evaluar la seguridad entre los brazos de tratamiento
    ? Determinar la farmacocinética de idasanutlin y citarabina
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age >=18 years
    - Documented/confirmed 1st/2nd refractory/relapsed AML using World Health Organization classification, except acute promyelocytic leukemia
    - No more than 2 prior induction regimens (excl. prior HSCT) and one must have included cytarabine with an anthracycline (or anthracenedione)
    - Eastern Cooperative Oncology Group performance status of 0 to 1
    - Patient should be a potential candidate for allogeneic HSCT
    - Adequate hepatic and renal function.
    -Edad ? 18 años.
    -Primera o segunda LMA refractaria o en recaída documentada o confirmada según la
    clasificación de la Organización Mundial de la Salud, excepto leucemia promielocítica
    aguda.
    -No más de dos pautas de inducción previas (excluido un TCMH previo), una de las cuales
    tendrá que haber incluido citarabina con una antraciclina (o antracenodiona).
    -Estado funcional del Eastern Cooperative Oncology Group de 0 o 1
    -El paciente ha de ser un posible candidato a recibir un alo-TCMH.
    · Función hepática y renal adecuada
    E.4Principal exclusion criteria
    - Patients with CR1 duration of >1 year AND age <60 years
    - Patients with AML with myelodysplasia related changes, or AML that has developed as a consequence of an AHD
    - AML secondary to any prior chemotherapy unrelated to leukemia
    - Patients who have received more than two prior cytarabine containing induction regimens for AML
    - Patients who have relapsed within 90 days after therapy with intermediate-dose cytosine arabinoside (IDAC) or high-dose cytosine arabinoside (HiDAC) containing regimens
    - Patients who have received allogeneic HSCT within 90 days prior to randomization
    - Patients who have received immunosuppressive therapy for graft versus host disease (G versus HD) within 2 weeks prior to study start
    - Prior treatment with a Murine Double Minute 2 (MDM2) antagonist
    - Patients receiving any other investigational or commercial agents or therapies administered with the intention to treat their malignancy
    - Patients with a history of other malignancy within 5 years prior to screening
    - Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
    - Pregnant or breastfeeding patients.
    -Pacientes con una duración de la RC1 > 1 año Y una edad < 60 años.
    -Pacientes con LMA con cambios relacionados con mielodisplasia o LMA que se ha
    desarrollado como consecuencia de un trastorno hematológico previo (THP)
    -LMA secundaria a cualquier quimioterapia previa no relacionada con la leucemia.
    -Pacientes que hayan recibido más de dos pautas de inducción previas con citarabina para
    tratar la LMA.
    -Pacientes que hayan presentado recaída en los 90 días siguientes al tratamiento con
    pautas que contengan IDAC o HiDAC.
    -Pacientes que hayan recibido un alo-TCMH en los 90 días previos a la aleatorización.
    -Pacientes que hayan recibido tratamiento inmunodepresor por una enfermedad del injerto
    contra el huésped (EICH) en las 2 semanas previas al comienzo del estudio.
    -Tratamiento previo con un antagonista de MDM2.
    -Pacientes que hayan recibido cualquier otro fármaco o tratamiento en investigación o
    comercializado administrado con intención de tratar su neoplasia maligna
    -Pacientes con antecedentes de otra neoplasia maligna en los 5 años previos a la selección
    -Pacientes que presenten trastornos médicos graves o incontrolados u otros trastornos que
    pudieran afectar a su participación en el estudio
    -Pacientes embarazadas o en período de lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival (OS) in TP53 wild-type population.
    Supervivencia Global (SG) en la población con TP53 no mutado
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Interim analysis, after 120 patients enrolled
    - primary analysis, approximately 4.5 years after study start.
    -Analisis intermedio, después de 120 pacientes randomizados
    -Analisis primario, aproximadamente 4,5 años después del comienzo del estudio
    E.5.2Secondary end point(s)
    1. OS in the all-patient population
    2. CR and CRp proportions at the end of induction in the TP53 wild-type population
    3. Overall remission rate (ORR) (CR, CRp and CRi) proportion at the end of induction in the TP53 wild-type population
    4. EFS in the TP53 wild-type population
    5. LFS in the TP53 wild-type population
    6. Proportion of HSCT in the TP53 wild-type population
    7. CR and CRp proportions at the end of induction in the overall population
    8. ORR (CR, CRp and CRi) proportion at the end of induction in the overall population
    9. EFS in the overall population
    10. LFS in the overall population
    11. Proportion of HSCT in the overall population.
    1-SG en la población global
    2- Proporciones de RC y RCp al final del tratamiento de inducción en la población con TP53 no mutado
    3-Proporción de TRG (RC, RCp y RCi) al final del tratamiento de inducción en la población
    con TP53 no mutado.
    4-SSE en la población con TP53 no mutado.
    5-SSL en la población con TP53 no mutado.
    6-Proporción de TCMH en la población con TP53 no mutado.
    7-Proporciones de RC y RCp al final del tratamiento de inducción en la población global
    8-Proporción de TRG (RC, RCp y RCi) al final del tratamiento de inducción en la población global.
    9-SSE en la población global.
    10-SSL en la población global.
    11-Proporción de TCMH en la población global.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Interim analysis, after 120 patients enrolled
    - primary analysis, approximately 4.5 years after study start.
    -Analisis intermedio, después de 120 pacientes randomizados
    -Analisis primario, aproximadamente 4,5 años después del comienzo del 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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA56
    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
    Australia
    Austria
    Belgium
    Canada
    Finland
    France
    Germany
    Israel
    Italy
    Korea, Republic of
    Netherlands
    New Zealand
    Norway
    Russian Federation
    Spain
    Switzerland
    Taiwan
    United Kingdom
    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 years4
    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 years4
    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: 176
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 264
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 338
    F.4.2.2In the whole clinical trial 440
    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'.
    Ninguno.
    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 Decision2015-12-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-07
    P. End of Trial
    P.End of Trial StatusOngoing
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