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    The EU Clinical Trials Register currently displays   31553   clinical trials with a EudraCT protocol, of which   5083   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2015-000140-42
    Sponsor's Protocol Code Number:2215-CL-0301
    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:2015-10-15
    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 number2015-000140-42
    A.3Full title of the trial
    A Phase 3 Open-Label, Multicenter, Randomized Study of ASP2215 versus Salvage Chemotherapy in Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) with FLT3 Mutation
    Estudio de fase 3 abierto, multicéntrico y aleatorizado de ASP2215 frente a quimioterapia de rescate en pacientes con leucemia mieloide aguda (LMA) recidivante o resistente con mutación en FLT3
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This is a phase 3, open-label, multicenter, randomized study to compare the efficacy and safety of ASP2215 therapy to salvage chemotherapy in FLT3-mutated AML subjects who are refractory to or have relapsed after first-line AML therapy.
    Este es un estudio de fase 3, abierto, multicéntrico, aleatorizado para comparar la eficacia y seguridad del tratamiento con ASP2215 frente a la quimioterapia de rescate en sujetos con leucemia mieloide aguda (LMA) con mutación en FLT3 y que son recidivantes o resistentes después de la primera línea de terapia de LMA.
    A.4.1Sponsor's protocol code number2215-CL-0301
    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 SponsorAstellas Pharma Global Development, Inc. (APGD)
    B.1.3.4CountryUnited States
    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 supportAstellas Pharma Global Development, Inc. (APGD)
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstellas Pharma Global Development, Inc. (APGD)
    B.5.2Functional name of contact pointTimothy Farber
    B.5.3 Address:
    B.5.3.1Street Address1 Astellas Way
    B.5.3.2Town/ cityNorthbrook, IL
    B.5.3.3Post code60062
    B.5.3.4CountryUnited States
    B.5.4Telephone number+34900 834223
    B.5.6E-mailRegistroEspanolDeEstudiosClinicos@druginfo.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 nameASP2215
    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 INNASP2215 hemifumarate
    D.3.9.2Current sponsor codeASP2215 hemifumarate
    D.3.9.3Other descriptive nameAS2582215-FMA and ELK-693M
    D.3.9.4EV Substance CodeSUB166897
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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.2.5The 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
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCytarabine
    D.3.9.3Other descriptive nameCYTARABINE
    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 number20
    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: 3
    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.2.5The 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 nameAzacitidine
    D.3.4Pharmaceutical form Powder for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAZACITIDINE
    D.3.9.1CAS number 320-67-2
    D.3.9.4EV Substance CodeSUB05624MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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.IMP: 4
    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.2.5The 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 nameMitoxantrone
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    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 INNMitoxantrone
    D.3.9.1CAS number 65271-80-9
    D.3.9.3Other descriptive nameMITOXANTRONE
    D.3.9.4EV Substance CodeSUB09012MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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.IMP: 5
    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.2.5The 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 nameEtoposide
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    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 INNEtoposide
    D.3.9.3Other descriptive nameETOPOSIDE
    D.3.9.4EV Substance CodeSUB07337MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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: 6
    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.2.5The 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/infusion
    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.3.9.3Other descriptive nameCYTARABINE
    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.IMP: 7
    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.2.5The 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 nameFilgrastim
    D.3.4Pharmaceutical form Solution for injection
    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 INNFILGRASTIM
    D.3.9.1CAS number 121181-53-1
    D.3.9.4EV Substance CodeSUB07627MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.3
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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: 8
    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.2.5The 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 nameFludarabine
    D.3.4Pharmaceutical form Concentrate for solution for injection/infusion
    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 INNFLUDARABINE PHOSPHATE
    D.3.9.1CAS number 75607-67-9
    D.3.9.4EV Substance CodeSUB13897MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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: 9
    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.2.5The 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/infusion
    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.3.9.3Other descriptive nameCYTARABINE
    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.IMP: 10
    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.2.5The 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 nameIdarubicin
    D.3.4Pharmaceutical form Powder for 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 INNIdarubicin
    D.3.9.3Other descriptive nameIDARUBICIN
    D.3.9.4EV Substance CodeSUB08111MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Relapsed or Refractory Acute Myeloid Leukemia
    Leucemia mieloide aguda recidivante o resistente
    E.1.1.1Medical condition in easily understood language
    AML is cancer of myeloid line of blood cells characterized by rapid growth of abnormal white blood cells that accumulate in bone marrow and interfere with production of normal blood cells.
    LMA es el cáncer de la línea mieloide de las células de la sangre caracterizado por un rápido crecimiento anormal de glóbulos blancos que se acumulan en la médula ósea
    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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to determine the clinical benefit of ASP2215 therapy in subjects with FMS-like tyrosine kinase (FLT3) mutated AML who are refractory to or have relapsed after first-line AML therapy as shown with overall survival (OS) compared to salvage chemotherapy.
    El objetivo principal es determinar el efecto clínico beneficioso del tratamiento con ASP2215 en sujetos con LMA con mutación en la tirosina quinasa similar al FMS (FLT3) que son resistentes al tratamiento de primera línea de la LMA o sufren recidiva, demostrado por la supervivencia global (SG), en comparación con quimioterapia de rescate.
    E.2.2Secondary objectives of the trial
    The key secondary objectives are to:
    - Determine the overall efficacy in event-free survival (EFS) of ASP2215 compared to salvage chemotherapy.
    - Determine the overall efficacy in complete remission (CR) rate of ASP2215 compared to salvage chemotherapy.

    The secondary objectives are to:
    Evaluate the safety and efficacy of ASP2215 therapy versus salvage chemotherapy in terms of:
    - leukemia-free survival (LFS)
    - duration of remission
    - composite complete remission (CRc) rate
    - transplantation rate
    - patient reported fatigue (Brief Fatigue Inventory [BFI])
    - adverse events (AEs), safety labs, vital signs, ophthalmologic exams, electrocardiograms
    Los objetivos secundarios clave son:
    - Determinar la eficacia global en la supervivencia libre de episodios (SLE) de ASP2215 en comparación con la quimioterapia de rescate.
    - Determinar la eficacia global en la tasa de remisión completa (RC) de ASP2215 en comparación con la quimioterapia de rescate.

    Los objetivos secundarios son:
    Evaluar la seguridad y la eficacia del tratamiento con ASP2215 en comparación con la quimioterapia de rescate en cuanto a:
    - supervivencia libre de leucemia (SLL)
    - duración de la remisión
    - tasa de remisión completa compuesta (RCc)
    - tasa de trasplante
    - cansancio comunicado por el paciente (Cuestionario abreviado sobre cansancio [BFI])
    - acontecimientos adversos (AA), valores analíticos de seguridad, constantes vitales, exploraciones oftalmológicas, electrocardiogramas
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Retrospective PGx Sub-study (Optional).

    Please refer to section 12.5 of the protocol
    Subestudio FG retrospectivo (opcional)

    Refiérase a la sección 12.5 del Protocolo
    E.3Principal inclusion criteria
    Subject is eligible for the study if all of the following apply:
    1. Institutional Review Board-/Independent Ethics Committee-approved written Informed Consent and privacy language as per national regulations (e.g., Health Insurance Portability and Accountability Act Authorization for United States sites) must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
    2. Subject is considered an adult according to local regulation at the time of signing informed consent.
    3. Subject has a diagnosis of primary AML or AML secondary to myelodysplastic syndrome (MDS) according to World Health Organization classification [Swerdlow et al, 2008] as determined by pathology review at the treating institution.
    4. Subject is refractory to or relapsed after first-line AML therapy (with or without HSCT).
    - Refractory to first-line AML therapy is defined as:
    a) Subject did not achieve CR/CRi/CRp under initial therapy. A subject eligible for standard therapy must receive at least 1 cycle of an anthracycline containing induction block in standard dose for the selected induction regimen. A subject not eligible for standard therapy must have received at least 1 complete block of induction therapy seen as the optimum choice of therapy to induce remission for this subject as per investigators assessment.
    - Untreated first hematologic relapse is defined as:
    a) Subject must have achieved a CR/CRi/CRp (criteria as defined by [Cheson et al, 2003], see Section 5.3) with first line treatment and has hematologic relapse.
    5. Subject is positive for FLT3 activating mutation in bone marrow or whole blood as determined by central lab. In the investigator?s opinion, a subject with rapidly proliferative disease and unable to wait for the central lab results can be enrolled based on local tests.
    6. Subject has an ECOG performance status <= 2.
    7. Subject is eligible for preselected salvage chemotherapy according to investigator assessment.
    8. Subject must meet the following criteria as indicated on the clinical laboratory tests:
    - Serum aspartate aminotransferase and alanine aminotransferase ? 2.5 x upper limit of normal
    (ULN)
    - Serum total bilirubin ? 1.5 x ULN
    - Serum creatinine ? 1.5 x ULN or an estimated glomerular filtration rate of > 50 mL/min as
    calculated by the Modification of Diet in Renal Disease equation.
    9. Subject is suitable for oral administration of study drug.
    10. Female subject must either:
    * Be of nonchild bearing potential:
    - postmenopausal (defined as at least 1 year without any menses) prior to screening, or
    - documented surgically sterile (at least 1 month prior to screening)
    * Or, if of childbearing potential,
    - Agree not to try to become pregnant during the study and for 45 days after the final study drug administration
    - And have a negative urine pregnancy test at screening
    - And, if heterosexually active, agree to consistently use 2 forms of highly effective birth control (at least 1 of which must be a barrier method) starting at screening and throughout the study period and for 45 days after the final study drug administration.
    11. Female subject must agree not to breastfeed at screening and throughout the study period and for 45 days after the final study drug administration.
    12. Female subject must not donate ova starting at screening and throughout the study period and for 45 days after the final study drug administration.
    13. Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control? (at least 1 of which must be a barrier method) starting at screening and continue throughout the study period and for 105 days after the final study drug administration.
    * Highly effective forms of birth control include:
    - Consistent and correct usage of established oral contraception
    - Established intrauterine device or intrauterine system
    - Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository (spermicidal foam/gel/film/cream/suppository is not applicable to sites in Japan)
    - Calendar-based contraceptive methods (Knaus-Ogino or rhythm method applicable to sites in Japan only)
    14. Male subject must not donate sperm starting at screening and throughout the study period and for 105 days after the final study drug administration.
    15. Subject agrees not to participate in another interventional study while on treatment.

    Waivers to the inclusion criteria will NOT be allowed.
    El sujeto es elegible para el estudio si cumple todos los criterios siguientes:
    1. Deberán obtenerse el consentimiento informado por escrito y la declaración relativa a la privacidad aprobados por el comité ético de investigación clínica (CEIC), de conformidad con la legislación nacional (p. ej., autorización según la Ley estadounidense sobre transferencia y responsabilidad de seguros sanitarios en los centros de EE UU) del sujeto o de su representante legal autorizado antes de realizar cualquiera de los procedimientos relacionados con el estudio (incluida la retirada de la medicación prohibida, si procede).
    2. El sujeto es mayor de edad según la legislación local en el momento en que se firma el consentimiento informado.
    3. El sujeto tiene un diagnóstico de LMA primaria o de LMA secundaria a un síndrome mielodisplásico (SMD) según la clasificación de la Organización Mundial de la Salud [Swerdlow y cols., 2008], determinado mediante estudio anatomopatológico en el centro que lo trata.
    4. El sujeto muestra resistencia o recidiva después del tratamiento de primera línea de la LMA (con o sin TCPH).
    -La resistencia al tratamiento de primera línea de la LMA se define como:
    a. La ausencia de RC/RCi/RCp con el tratamiento inicial. Un sujeto elegible para el tratamiento convencional deberá recibir al menos 1 ciclo de un bloque de inducción que contenga una antraciclina en la dosis habitual para el régimen de inducción seleccionado. Un sujeto no elegible para el tratamiento convencional deberá haber recibido al menos 1 bloque completo del tratamiento de inducción considerado laopción terapéutica óptima para inducir remisión en este sujeto según la valoración del investigador.
    -La primera recidiva hematológica no tratada se define como:
    a. El sujeto tiene que haber conseguido una RC/RCi/RCp (criterios según la definición de [Cheson y cols. 2003], véase la sección 5.3) después del tratamiento de primera línea y presentar recidiva hematológica.
    b.
    5. El sujeto da positivo para la mutación activadora en FLT3 en médula ósea o en sangre entera según el laboratorio central. A criterio del investigador, cuando un sujeto presente enfermedad en proliferación rápida y no pueda esperarse a tener los resultados del laboratorio central, se podrá incluir al sujeto basándose en los análisis locales.
    6. El sujeto tiene un estado funcional del ECOG <= 2.
    7. El sujeto es elegible para la quimioterapia de rescate preseleccionada según la valoración del investigador.
    8. El sujeto deberá cumplir los criterios siguientes en los análisis clínicos:
    - Alanina aminotransferasa (ALT) y aspartato aminotransferasa (AST) en suero <= 2,5 x límite superior de la normalidad (LSN)
    - Bilirrubina total en suero <= 1,5 x LSN
    - Creatinina sérica <= 1,5 x LSN o índice de filtración glomerular estimado > 50 ml/min, calculada mediante la ecuación de modificación de la dieta en la nefropatía.
    9. El sujeto admite la administración oral del fármaco del estudio.
    10. Las mujeres deberán:
    *No estar en edad fértil:
    - ser posmenopáusicas (haber estado al menos 1 año sin menstruación) antes de la selección o
    - haber sido esterilizadas quirúrgicamente (al menos 1 mes antes de la selección)
    * O, si están en edad fértil,
    - Comprometerse a no intentar quedarse embarazadas durante el estudio y en los 45 días siguientes a la última administración del fármaco del estudio
    - Y dar negativo en una prueba de embarazo en orina realizada en la selección
    - Y, en caso de actividad heterosexual, comprometerse a utilizar de modo constante 2 métodos anticonceptivos muy eficaces? (de los que al menos 1 deberá ser un método de barrera) desde la selección y durante todo el período del estudio y en los 45 días siguientes a la última administración del fármaco del estudio.
    11. Las mujeres deberán comprometerse a evitar la lactancia materna en la selección, durante todo el período del estudio y en los 45 días siguientes a la última administración del fármaco del estudio.
    12. Las mujeres deberán abstenerse de donar óvulos en la selección, durante todo el período del estudio y durante los 45 días siguientes a la última administración del fármaco del estudio.
    13. Los pacientes varones y sus cónyuges/parejas femeninas en edad fértil deberán utilizar 2 métodos anticonceptivos muy eficaces (de los que al menos uno deberá ser un método de barrera) desde la selección, durante todo el período del estudio y durante los 105 días siguientes a la última administración del fármaco del estudio.
    14. Los pacientes varones deberán abstenerse de donar semen desde la selección, durante todo el período del estudio y durante los 105 días siguientes a la última administración del fármaco del estudio.
    15. El sujeto se compromete a no participar en otro estudio de intervención mientras esté recibiendo tratamiento.
    NO se permitirán excepciones a los criterios de inclusión.
    E.4Principal exclusion criteria
    Subject will be excluded from participation if any of the following apply:

    1. Subject was diagnosed as acute promyelocytic leukemia.
    2. Subject has BCR-ABL-positive leukemia (chronic myelogenous leukemia in blast crisis).
    3. Subject has AML secondary to prior chemotherapy for other neoplasms (except for MDS).
    4. Subject is in second or later hematologic relapse or has received salvage therapy for refractory disease.
    5. Subject has clinically active central nervous system leukemia.
    6. Subject has been diagnosed with another malignancy, unless disease-free for at least 5 years. Subjects with treated nonmelanoma skin cancer, in situ carcinoma or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed. Subjects with organ-confined prostate cancer with no evidence of recurrent or progressive disease are eligible if hormonal therapy has been initiated or the malignancy has been surgically removed or treated with definitive radiotherapy.
    7. Subject has received prior treatment with ASP2215 or other FLT3 inhibitors (with the exception of sorafenib used in first-line therapy regimen as part of induction, consolidation and/or maintenance).
    8. Subject has clinically significant abnormality of coagulation profile, such as disseminated intravascular coagulation.
    9. Subject has had major surgery within 4 weeks prior to the first study dose.
    10. Subject has radiation therapy within 4 weeks prior to the first study dose.
    11. Subject has congestive heart failure New York Heart Association (NYHA) class 3 or 4 or subject with a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram performed within 1 month prior to study entry results in a left ventricular ejection fraction that is >= 45%
    12. Subjects with mean Fridericia-corrected QT interval (QTcF) > 450 ms at Screening based on central reading.
    13. Subjects with Long corrected QT interval (QTc) Syndrome at Screening.
    14. Subjects with hypokalemia and hypomagnesemia at Screening (defined as values below lower limit of normal [LLN]).
    15. Subject requires treatment with concomitant drugs that are strong inducers of cytochrome P450 (CYP) 3A.
    16. Subject requires treatment with concomitant drugs that are strong inhibitors or inducers of P-glycoprotein (P-gp) or substrates of multidrug and toxin extrusion protein 1 (MATE1) with the exception of drugs that are considered absolutely essential for the care of the subject.
    17. Subject requires treatment with concomitant drugs that target serotonin 5-hydroxytryptamine receptor 1 (5HT1R) or 5-hydroxytryptamine receptor 2B (5HT2BR) or sigma nonspecific receptor with the exception of drugs that are considered absolutely essential for the care of the subject.
    18. Subject has an active uncontrolled infection.
    19. Subject is known to have human immunodeficiency virus infection.
    20. Subject has active hepatitis B or C or other active hepatic disorder.
    21. Subject has any condition which, in the investigator?s opinion, makes the subject unsuitable for study participation.
    22. Subject has active clinically significant GVHD or is on treatment with systemic corticosteroids for GVHD.

    Waivers to the exclusion criteria will NOT be allowed.
    Se excluirá del estudio a los sujetos que cumplan alguno de los criterios siguientes:
    1. Al sujeto se le ha diagnosticado leucemia promielocítica aguda.
    2. El sujeto tiene leucemia positiva para BCR-ABL (leucemia mielógena crónica en crisis blástica).
    3. El sujeto tiene LMA secundaria a quimioterapia previa para otras neoplasias (excepto para SMD).
    4. El sujeto tiene una segunda o posterior recidiva hematológica o ha recibido tratamiento de rescate por enfermedad resistente.
    5. El sujeto tiene leucemia en el sistema nervioso central clínicamente activa.
    6. Se ha diagnosticado al sujeto otro proceso maligno, a menos que lleve al menos 5 años libre de enfermedad. Los sujetos con cáncer de piel distinto del melanoma, carcinoma in situ o neoplasia intraepitelial de cuello uterino tratados, sea cual sea el tiempo libre enfermedad, son elegibles para este estudio si se ha completado el tratamiento definitivo del proceso. Los sujetos con cáncer de próstata limitado al órgano sin signos de enfermedad recurrente o progresiva son elegibles si han iniciado hormonoterapia o la neoplasia maligna se ha extirpado quirúrgicamente o se ha tratado con radioterapia definitiva.
    7. El sujeto ha recibido tratamiento previo con ASP2215 u otro inhibidor de FLT3 (a excepción del sorafenib usado en el régimen de tratamiento de primera línea como parte de la inducción, la consolidación o el mantenimiento).
    8. El sujeto tiene una anomalía de importancia clínica en las pruebas de coagulación, como coagulación intravascular diseminada.
    9. Se ha sometido al sujeto a cirugía mayor en las 4 semanas previas a la primera dosis del estudio.
    10. El sujeto ha recibido radioterapia en las 4 semanas previas a la primera dosis del estudio.
    11. El sujeto tiene insuficiencia cardíaca congestiva de clase 3 o 4 de la New York Heart Association (NYHA) o antecedentes de insuficiencia cardíaca congestiva de clase 3 o 4 de la NYHA, a menos que en un ecocardiograma de selección realizado en el mes previo a la entrada en el estudio se determine una fracción de eyección del ventrículo izquierdo >= 45%.
    12. El sujeto tiene un valor medio de intervalo QTcF > 450 ms en la selección, según la interpretación central.
    13. El sujeto tiene síndrome de prolongación del intervalo QT corregido (QTc) en la selección.
    14. El sujeto tiene hipopotasemia e hipomagnesemia en la selección (definidas como valores por debajo del límite inferior de la normalidad [LIN]).15. El sujeto tiene una infección no controlada activa.
    16. Se sabe que el sujeto tiene infección por el virus de la inmunodeficiencia humana.
    17. El sujeto sufre hepatitis B o C activa u otro trastorno hepático activo.
    18. El sujeto sufre cualquier proceso que, en opinión del investigador, hace que no sea adecuado para participar en el estudio.
    19. El sujeto presenta EICH activa clínicamente significativa o está recibiendo tratamiento con corticosteroides sistémicos para la EICH.
    NO se permitirán excepciones a los criterios de exclusión.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint:
    - Overall Survival
    Criterio de valoración principal de eficacia:
    - Supervivencia global
    E.5.1.1Timepoint(s) of evaluation of this end point
    Please refer to section E.5.1 and also the protocol.
    Refiérase a la sección E.5.1 y al protocolo
    E.5.2Secondary end point(s)
    Key Secondary Efficacy Endpoints:
    - EFS
    - CR

    Secondary Efficacy Endpoints:
    - LFS
    - Duration of remission
    - CRc (CR + CRi + CRp)
    - Transplantation
    - BFI
    Criterios de valoración de la eficacia secundarios clave.
    - SLE
    - RC

    Criterios de valoración de la eficacia secundarios:
    - SLL
    - Duración de la remisión
    - RCc (RC + RCi + RCp)
    - Trasplante
    - BFI
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to section E.5.2 and also the protocol.
    Refiérase a la sección E.5.1 y al protocolo
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of Life (QoL)
    Calidad de vida (QoL)
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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 EEA51
    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
    Canada
    France
    Germany
    Ireland
    Israel
    Italy
    Japan
    Korea, Republic of
    Netherlands
    Poland
    Spain
    Taiwan
    Turkey
    United Kingdom
    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
    Last Visit of Last Subject
    Última visita del último sujeto
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months2
    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
    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) Yes
    F.1.2.1Number of subjects for this age range: 240
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 129
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 121
    F.4.2.2In the whole clinical trial 369
    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)
    Standard of Care
    Tratamiento estándar
    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 Decision2015-11-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-11
    P. End of Trial
    P.End of Trial StatusOngoing
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