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    Summary
    EudraCT Number:2017-002822-19
    Sponsor's Protocol Code Number:B1371019
    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:2018-06-27
    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 number2017-002822-19
    A.3Full title of the trial
    A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA
    ESTUDIO ALEATORIZADO (1:1), DOBLE CIEGO, MULTICÉNTRICO Y CONTROLADO CON PLACEBO PARA EVALUAR LA QUIMIOTERAPIA INTENSIVA CON O SIN GLASDEGIB (PF-04449913) O LA AZACITIDINA (AZA) CON O SIN GLASDEGIB EN PACIENTES CON LEUCEMIA MIELOIDE AGUDA NO TRATADA PREVIAMENTE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA
    ESTUDIO QUE EVALUA LA QUIMIOTERAPIA INTENSIVA CON O SIN GLASDEGIB (PF-04449913) O AZACITIDINA (AZA) CON O SIN GLASDEGIB EN PACIENTES CON LEUCEMIA MIELOIDE AGUDA NO TRATADA PREVIAMENTE
    A.4.1Sponsor's protocol code numberB1371019
    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 SponsorPfizer Inc., 235 East 42nd Street, New York, NY 10017
    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 supportPfizer Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc.
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018007181021
    B.5.5Fax number0013037391119
    B.5.6E-mailclinicaltrials.govcallcenter@pfizer.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 nameglasdegib 25 mg tablet
    D.3.2Product code PF-04449913
    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 INNGLASDEGIB
    D.3.9.2Current sponsor codePF-04449913
    D.3.9.4EV Substance CodeSUB179278
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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: 2
    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 nameglasdegib 100 mg tablets
    D.3.2Product code PF-04449913
    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 INNGLASDEGIB
    D.3.9.2Current sponsor codePF-04449913
    D.3.9.4EV Substance CodeSUB179278
    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: 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.2.1.1.1Trade name Vidaza 25 mg/mL powder for suspension for injection
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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/3/07/509
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder for suspension 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 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/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: 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.2.1.1.1Trade name Daunorubicin 20 mg Powder for Injection
    D.2.1.1.2Name of the Marketing Authorisation holderZentiva
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Powder 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 INNDAUNORUBICIN
    D.3.9.1CAS number 20830-81-3
    D.3.9.4EV Substance CodeSUB06917MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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: 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.2.1.1.1Trade name ARA-cell® 100 mg Injection
    D.2.1.1.2Name of the Marketing Authorisation holdercell pharm GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical 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.3.9.3Other 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: 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.2.1.1.1Trade name Cytarabine 100 mg/ml solution for injection or infusion.
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi Oncology Plc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical 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.3.9.3Other 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.2.1.1.1Trade name Cytarabine 20 mg/ml solution for injection or infusion.
    D.2.1.1.2Name of the Marketing Authorisation holderHospira, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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.3.4Pharmaceutical 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.3.9.3Other 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: 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.2.1.1.1Trade name Cytarabine 100 mg/ml solution for injection or infusion.
    D.2.1.1.2Name of the Marketing Authorisation holderHospira, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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.3.4Pharmaceutical 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.3.9.3Other 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.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
    D.8 Placebo: 2
    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 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 demonstrate that glasdegib is superior to placebo in combination with azacitidine (non-intensive study) or cytarabine and daunorubicin (intensive study) in prolonging OS in subjects with untreated AML.
    Demostrar que glasdegib es superior al placebo en combinación con azacitidina (estudio no intensivo) y citarabina y daunorubicina (estudio intensivo) en la prolongación de la SG en sujetos con LMA no tratada.
    E.2.2Secondary objectives of the trial
    To compare fatigue score post-baseline as measured by MDASI-AML/MDS in both treatment arms;
    To compare glasdegib versus placebo in combination with azacitidine (non-intensive study) or ‘7+3’ (cytarabine and daunorubicin) in improving other clinical efficacy measures;
    To estimate the duration of response in both treatment arms;
    To estimate the time to response in both treatment arms in the Non-intensive study only;
    To compare Event-free Survival (EFS) in both treatment arms;
    To compare PRO measurements in both treatment arms;
    To evaluate the overall safety profile in both treatment arms;
    To evaluate laboratory abnormalities in both treatment arms;
    To characterize the PK of glasdegib;
    To characterize treatment effects on the QTc interval
    Comparar la puntación de fatiga posinicial según se mide mediante el cuestionario MDASI-LMA/MDS en ambos grupos de tratamiento;
    Comparar glasdegib frente a placebo en combinación con azacitidina (estudio no intensivo) o ‘7+3’ (citarabina y daunorubicina) en la mejora de otras medidas de eficacia clínica;
    Estimar la duración de la respuesta en ambos grupos de tratamiento;
    Estimar el tiempo hasta la respuesta en ambos grupos de tratamiento exclusivamente en el estudio no intensivo;
    Comparar la supervivencia sin acontecimientos (SSA) en ambos grupos de tratamiento;
    Comparar las medidas de RNP en ambos grupos de tratamiento;
    Evaluar el perfil de seguridad global en ambos grupos de tratamiento;
    Evaluar las anomalías de laboratorio en ambos grupos de tratamiento;
    Caracterizar la farmacocinética (FC) de glasdegib;
    Caracterizar los efectos del tratamiento sobre el intervalo QTc
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Banked biospecimens will be collected from subjects for exploratory research relating to the drug and AML. Protocol version is Amendment 3 dated on 1 March 2018.
    The primary purpose is to examine DNA; however, the biospecimen may also be used to study other molecules (eg, RNA, proteins, and metabolites).
    Se recogeran muestras biológicas conservadas de los sujetos para investigación exploratoria relacionada con la medicación y con la leucemia mieloide aguda (LMA). La versión del Protocolo es la Enmienda 3 de fecha 1 de marzo de 2018.
    El objetivo principal es examinar el ADN; sin embargo, esta muestra biológica conservada puede también ser usadas para estudiar otras moléculas (pej. el ARN, las proteínas y los metabolitos).
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the Intensive and Non-Intensive study (unless where indicated):
    1. Subjects with untreated AML according to the World Health Organization (WHO) 2016 Classification, including those with:
    AML arising from MDS or another antecedent hematologic disease (AHD).
    AML after previous cytotoxic therapy or radiation (secondary AML).
    2. ≥18 years of age (In Japan, ≥20 years of age).
    3. Adequate Organ Function as defined by the following:
    Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) ≤ 3 x upper limit of normal (ULN), excluding subjects with liver function abnormalities due to underlying malignancy.
    Total serum bilirubin ≤2 x ULN (except subjects with documented Gilbert’s syndrome).
    Estimated creatinine clearance ≥30 mL/min as calculated using the standard method for the institution.
    4. QTc interval ≤470 msec using the Fridericia correction (QTcF).
    5. All anti-cancer treatments (unless specified) should be discontinued ≥ 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational anticancer agents, hormones, anagrelide or cytokines.
    For control of rapidly progressing leukemia, all-trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib.
    6. Serum or urine pregnancy test (for female subjects of childbearing potential) with a minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin (hCG) negative at screening.
    7. Male and female subjects of childbearing potential and at risk for pregnancy must agree to use at least one highly effective method of contraception throughout the study and for 180 days after the last dose of azacitidine, cytarabine, or daunorubicin; and the last dose
    of glasdegib or placebo, whichever occurs later.
    8. Female subjects of non-childbearing potential must meet at least 1 of the following criteria:
    a. Have undergone a documented hysterectomy and/or bilateral oophorectomy;
    b. Have medically confirmed ovarian failure; or
    c. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state.
    All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.
    9. Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.
    10. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
    11. Subjects who are willing and able to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures (including bone marrow [BM] assessments).
    Los sujetos deben cumplir la totalidad de los siguientes criterios de inclusión para ser aptos para su inclusión en el estudio intensivo y no intensivo (a menos que se indique lo contrario):
    1. Los sujetos con LMA no tratados según la Clasificación de la Organización Mundial de la Salud (OMS) de 2016, incluidos aquellos con:
    LMA surgida de MDS u otra enfermedad hematológica previa (EHP).
    LMA tras tratamiento citotóxico o radioterapia previa (LMA secundaria).
    2. ≥18 años de edad (en Japón, ≥20 años de edad).
    3. Tener una función orgánica adecuada según lo definido por los siguientes criterios:
    Aspartato aminotransferasa (AST) sérica y alanina aminostransferasa (ALT) sérica ≤3 veces el límite superior de la normalidad (LSN), excluyendo a los
    sujetos con anomalías en la función hepática debido a la neoplasia maligna subyacente.
    Bilirrubina sérica total ≤2 veces el LSN (excepto sujetos con síndrome de Gilbert documentado).
    Aclaramiento de creatinina estimado ≥ 30 ml/min, calculado utilizando el método habitual del centro.
    4. Intervalo QTc ≤470 ms usando la corrección de Fridericia (QTcF).
    5. Todos los tratamientos antineoplásicos (a menos que se indique) se interrumpirán ≥ 2 semanas de la entrada en el estudio, por ejemplo: quimioterapia dirigida, radioterapia, fármacos antineoplásicos en investigación, hormonas, anagrelida o citocinas.
    Para el control de la leucemia de progresión rápida, pueden usarse ácido retinoico todo-trans (ATRA), hidroxiurea y/o leucoféresis antes y hasta 1 semana después de la primera dosis de glasdegib.
    6. Prueba de embarazo en suero u orina (para mujeres en edad fértil) con una sensibilidad mínima de 25 IU/l o unidades equivalentes de gonadotropina coriónica humana (hCG) negativa durante la selección.
    7. Los sujetos de ambos sexos fértiles, especialmente las mujeres en edad fértil, deben aceptar utilizar al menos un método anticonceptivo altamente eficaz durante el estudio y en los 180 días posteriores a la última dosis de azacitidina, citarabina o daunorubicina, y la última dosis de glasdegib o placebo, lo que suceda más tarde.
    8. Las pacientes que no estén en edad fértil deben cumplir al menos 1 de los criterios siguientes:
    a. haberse sometido a histerectomía u ovariectomía bilateral documentada;
    b. presentar insuficiencia ovárica médicamente confirmada; o
    c. haber alcanzado el estado posmenopáusico, definido como: cese de la menstruación periódica durante al menos 12 meses seguidos sin una causa
    patológica o fisiológica alternativa y con un nivel de hormona foliculoestimulante (FSH) sérica que confirme este estado posmenopáusico.
    Todas las demás mujeres (incluidas las que se hayan sometido a ligadura de trompas) se considerarán en edad fértil.
    9. Consentimiento para la obtención de una muestra de saliva para realizar un análisis comparador de la línea germinal, siempre que no lo prohíba la normativa local o la decisión del comité ético (CE).
    10. Constancia de un documento de consentimiento informado firmado y fechado personalmente que indique que se ha informado al paciente de todos los aspectos pertinentes del estudio.
    11. Sujetos dispuestos y capaces de cumplir con las visitas programadas del estudio, los planes de tratamiento, las pruebas analíticas y demás procedimientos del estudio (incluidas las valoraciones de médula ósea [MO]).
    E.4Principal exclusion criteria
    Subjects with any of the following characteristics/conditions will not be included in the
    study:
    1. Acute Promyelocytic Leukemia (APL) and APLwith PML-RARA, subjects (WHO 2016 classification).
    2. AML with BCR-ABL1 or t(9;22)(q34;q11.2) as a sole abnormality.
    Complex genetics may include t(9;22) cytogenetic translocation.
    3. Subjects with known active CNS leukemia.
    4. Participation in other clinical studies involving investigational drug(s) other than anti-cancer agents (Phases 1-4) within 4 weeks prior study entry and/or during study participation.
    5. Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.
    6. Subjects with another active malignancy on treatment with the exception of basal cell carcinoma, non-melanoma skin cancer, cervical carcinoma-in-situ. Other prior or concurrent malignancies will be considered on a case-by-case basis.
    7. Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias
    (including sustained ventricular tachyarrhythmia), left bundle branch block or bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms.
    8. Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML.
    9. Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only.
    10. Cumulative anthracycline dose equivalent of ≥550 mg/m2 of daunorubicin for the Intensive Chemotherapy Study only.
    11. Known malabsorption syndrome or other condition that may significantly impair absorption of study medication in the investigator’s judgment (eg, gastrectomy, lap band, Crohn’s disease) and inability or unwillingness to swallow tablets or capsules.
    12. Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers (Appendix 5).
    13. Concurrent administration of herbal preparations.
    14. Major surgery or radiation within 4 weeks of starting study treatment.
    15. Documented or suspected hypersensitivity to any one of the following:
    For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side-effects) or daunorubicin.
    For subjects assigned to non-intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol.
    16. Known active drug or alcohol abuse.
    17. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
    18. Pregnant females or breastfeeding female subjects.
    19. Known recent or active suicidal ideation or behavior.
    20. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
    No se incluirá en el estudio a ningún sujeto con alguna de las características o trastornos que se indican a continuación:
    1. Sujetos con leucemia promielocítica aguda (LPA) y LPA con el gen LPM-RARA (clasificación de la OMS de 2016).
    2. LMA con mutación BCR-ABL1 o t(9;22)(q34;q11.2) como única anomalía.
    Los complejos genéticos pueden incluir una translocación citogenética t(9;22).
    3. Sujetos con leucemia del SNC activa conocida.
    4. Participación en otros estudios clínicos que incluyan fármacos en investigación distintos de fármacos antineoplásicos (fases 1-4) en las 4 semanas previas a la entrada en el estudio y/o durante la participación en el mismo.
    5. Sujetos que se sabe que son resistentes a las transfusiones de plaquetas o de glóbulos rojos empaquetados según las directrices de la institución, o paciente que rechaza tratamiento adyuvante con hemoderivados.
    6. Sujetos con otra neoplasia maligna activa en tratamiento a excepción de carcinoma basocelular, cáncer de piel no melanoma, carcinoma cervicouterino in situ. Otras neoplasias malignas previas o concurrentes se considerarán caso por caso.
    7. Cualquiera de los trastornos siguientes en curso o en los 6 meses previos: infarto de miocardio, síndrome de QT largo congénito, torsade de pointes (taquicardia ventricular en entorchado), arritmias sintomáticas (incluyendo taquiarritmia ventricular mantenida), hemibloqueo ventricular de la rama izquierda o bloqueo bifascicular, angina inestable, injerto de revascularización coronaria/periférica, insuficiencia cardíaca congestiva sintomática (ICC de clase III o IV según la Asociación de Cardiología de Nueva York), accidente cerebrovascular, accidente isquémico transitorio o embolia pulmonar sintomática así como bradicardia definida como <50 lpm.
    8. Sujetos con una infección sistémica activa, potencialmente mortal o clínicamente significativa no controlada no relacionada con la LMA.
    9. Los sujetos con fracción de eyección del ventrículo izquierdo (FEVI) <50 % quedan excluidos exclusivamente del estudio de quimioterapia intensiva.
    10. Dosis de antraciclina acumulada equivalente a ≥550 mg/m2 de daunorubicina exclusivamente para el estudio de quimioterapia intensiva.
    11. Síndrome de malabsorción conocido y otras afecciones que puedan alterar significativamente la absorción del medicamento del estudio en opinión del investigador (p. ej., gastrectomía, banda gástrica, enfermedad de Crohn) e incapacidad o falta de voluntad para tragar comprimidos o cápsulas.
    12. Necesidad de uso actual o previo de fármacos conocidos como inductores potentes de CYP3A4/5 (Apéndice 5).
    13. Administración concurrente de preparaciones fitoterápicas.
    14. Cirugía mayor o radiación en las 4 semanas previas al comienzo del tratamiento del estudio.
    15. Hipersensibilidad documentada o sospechosa a cualquier de los siguientes compuestos:
    Para los sujetos asignados a quimioterapia intensiva, hipersensibilidad documentada o sospechosa a citarabina (sin incluir fiebre o exantema debido al
    fármaco, incluidos efectos adversos cerebelosos conocidos) o a daunorubicina.
    Para los sujetos asignados a quimioterapia no intensiva, hipersensibilidad documentada o sospecha de la misma a azacitidina o manitol.
    16. Consumo activo conocido de estupefacientes o alcohol.
    17. Otra afección médica o psiquiátrica aguda o crónica, incluidas pensamientos o conductas suicidas recientes (en el último año) o activas, o anomalías analíticas que puedan aumentar el riesgo asociado a participar en el estudio o a la administración del producto en investigación o que puedan interferir en la interpretación de los resultados del estudio y que, en opinión del investigador, harían inadecuada la entrada del sujeto en el estudio.
    18. Mujeres embarazados o en periodo de lactancia.
    19. Pensamientos o conductas suicidas recientes o activas conocidas.
    20. Miembros del personal del centro de investigación implicados directamente en la realización del estudio, así como sus familiares, miembros del personal del centro supervisados de cualquier otro modo por el investigador o sujetos que sean empleados de Pfizer, incluidos sus familiares, implicados directamente en la realización del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival
    Supervivencia global
    E.5.1.1Timepoint(s) of evaluation of this end point
    For the intensive chemotherapy population a first interim analysis for efficacy and futility is planned when 50% of death events have occurred.A second interim analysis for efficacy and futility is planned when 70% of death events have occurred or upon completion of enrollment of intensive chemotherapy subjects, whichever is later.
    For the non-intensive chemotherapy population an interim analysis for efficacy and futility is planned when 60% of death events have
    occurred or upon completion of enrollment of non-intensive chemotherapy subjects, whichever is later.
    Para la problación de quimioterapia intensiva está planeado un primer análisis provisional de la eficacia y la futilidad cuando el 50 % de los acontecimientos de muerte hayan ocurrido. Un segundo análisis provisional de la eficacia y la futabilidad está planeado cuando el 70% de los acontecimientos de muerte hayan ocurrido o tras la finalización de la inclusión de los pacientes de quimioterapia intensiva, lo que suceda después. Para la problación de quimioterapia no intensiva está planeado un análisis provisional de la eficacia y la futilidad cuando el 60 % de los acontecimientos de muerte hayan ocurrido o tras la finalización de la inclusión de los pacientes de quimioterapia no intensiva, lo que suceda después.
    E.5.2Secondary end point(s)
    Fatigue score measured by the MDASI-AML/MDS questionnaire;

    Rate of CR (including CRMRD-negative as assessed by multiparametric flow cytometry), CRi as defined by the ELN recommendations (2017), MLFS, PR and CR with partial hematologic recovery (CRh) for the Non-intensive study only;

    Duration of response (defined as CRi or better or CRh or better if applicable)*;

    Time to response (CRi or better -or CRh or better)* in the non-intensive study only;

    Event-free Survival

    PROs as measured by the M.D. Anderson Symptom Inventory AML/MDS Module (MDASI-AML/MDS), EuroQoL 5 Dimension questionnaire 5-Level version (EQ-5D-5L), Patient Global Impression of Symptoms (PGIS) and Patient Global Impression of Change (PGIC);

    Adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE v.4.03), timing, seriousness and relationship to study therapy;

    Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v.4.03) and timing;

    PK of glasdegib;

    QTc interval
    Puntuación de fatiga medida mediante el cuestionario MDASI-LMA/MDS;

    Tasa de RC (incluyendo RCMRD-negativo según la valoración mediante citometría de flujo multiparamétrica), RCi según se define en las recomendaciones de la ELN (2017), MFLS (estado morfológico libre de leucemia), RP y RC con recuperación hematológica parcial (RCh) exclusivamente para el estudio no intensivo;

    Duración de la respuesta (definida como RCi o mejor o RCh o mejor, si procede)*;

    Tiempo hasta la respuesta (RCi o mejor o RCh o mejor)* exclusivamente en el estudio no intensivo;

    Supervivencia libre de acontecimientos;

    RNP según se mide mediante el módulo de LMA/MDS del inventario de síntomas de M.D. Anderson (MDASI-LMA/MDS), la versión del cuestionario EuroQoL de 5 dimensiones y 5 niveles (EQ-5D-5L), impresión global del paciente de síntomas (Global Impression of Symptoms, PGIS) e impresión global del paciente del cambio (Patient Global Impression of Change, PGIC);

    Acontecimientos adversos caracterizados según tipo, frecuencia, intensidad (clasificada según los CTCAE del NCI, versión 4.03), cronología, gravedad y relación con el tratamiento del estudio;

    Anomalías de laboratorio caracterizadas según tipo, frecuencia, intensidad (clasificada según los CTCAE del NCI, versión 4.03) y cronología;

    FC de glasdegib;

    Intervalo QTc
    E.5.2.1Timepoint(s) of evaluation of this end point
    Along the study
    A lo largo 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 Yes
    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 Yes
    E.6.12Pharmacoeconomic Yes
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA74
    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
    Czech Republic
    France
    Germany
    Greece
    Hungary
    Israel
    Italy
    Japan
    Korea, Republic of
    Mexico
    Poland
    Romania
    Russian Federation
    Spain
    Sweden
    Taiwan
    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
    End of Study in all participating countries is defined as Last Subject Last Visit.
    Final del Estudio en todos los paises participantes se define como la última visita del último sujeto "LVLS"
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days6
    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: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 320
    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 state41
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 364
    F.4.2.2In the whole clinical trial 720
    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)
    As part of the protocol, the patient will be treated up to 2 years post randomization with glasdegib or placebo until they withdrawal or progress. Further treatment will be off protocol and will rely on judgment of their treating physician.
    Como parte del protocolo, el paciente será tratado hasta un máximo de 2 años tras la aleatorización con glasdegib o placebo hasta discontinuación o progreso de la enfermedad. Los siguientes tratamientos serán fuera de protocolo y dependerán del criterio de su médico 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 Decision2018-06-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-30
    P. End of Trial
    P.End of Trial StatusOngoing
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