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    Summary
    EudraCT Number:2016-001754-18
    Sponsor's Protocol Code Number:CLR_15_03
    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:2019-06-11
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2016-001754-18
    A.3Full title of the trial
    A Two-Part Phase 1/2 Study to Determine Safety, Tolerability, Pharmacokinetics, and Activity of K0706, a Novel Tyrosine Kinase Inhibitor (TKI), in Healthy Subjects and in Subjects with Chronic Myeloid Leukemia (CML) or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)
    Estudio de fase 1/2 de dos partes para determinar la seguridad, tolerabilidad, farmacocinética y actividad de K0706, un nuevo inhibidor de la tirosina cinasa (ITC), en pacientes sanos y pacientes con leucemia mieloide crónica (LMC) o leucemia linfoblástica aguda (LLA) positiva para el cromosoma Filadelfia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Determine Safety, Tolerability, Pharmacokinetics, and Activity of K0706 in Healthy Subjects and in Subjects with Chronic Myeloid Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
    Estudio para determinar la seguridad, tolerabilidad, farmacocinética y actividad de K0706 en pacientes sanos y pacientes con leucemia mieloide crónica o leucemia linfoblástica aguda positiva para el cromosoma Filadelfia
    A.4.1Sponsor's protocol code numberCLR_15_03
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02629692
    A.5.4Other Identifiers
    Name:IND NumberNumber:127347
    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 SponsorSun Pharma Advanced Research Company (SPARC) Limited
    B.1.3.4CountryIndia
    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 supportSun Pharma Advanced Research Company (SPARC) Limited
    B.4.2CountryIndia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSun Pharma Advanced Research Company (SPARC) Limited
    B.5.2Functional name of contact pointRosa Ayala Díaz
    B.5.3 Address:
    B.5.3.1Street AddressAv. Cordoba, s/n
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28041
    B.5.3.4CountrySpain
    B.5.4Telephone number34917792788 / 7792610
    B.5.6E-mailrosam.ayala@saludmadrid.org
    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 nameK0706
    D.3.2Product code K0706
    D.3.4Pharmaceutical form Capsule
    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 INNK0706
    D.3.9.2Current sponsor codeK0706
    D.3.9.3Other descriptive nameK0706
    D.3.9.4EV Substance CodeSUB184023
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number48
    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 nameK0706
    D.3.2Product code K0706
    D.3.4Pharmaceutical form Capsule
    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 INNK0706
    D.3.9.2Current sponsor codeK0706
    D.3.9.3Other descriptive nameK0706
    D.3.9.4EV Substance CodeSUB184023
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number24
    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 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 nameK0706
    D.3.2Product code K0706
    D.3.4Pharmaceutical form Capsule
    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 INNK0706
    D.3.9.2Current sponsor codeK0706
    D.3.9.3Other descriptive nameK0706
    D.3.9.4EV Substance CodeSUB184023
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number48
    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
    Chronic Myeloid Leukemia (CML) or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)
    Leucemia mieloide crónica (LMC) o leucemia linfoblástica aguda (LLA) positiva para el cromosoma Filadelfia
    E.1.1.1Medical condition in easily understood language
    Leukemia
    Leucemia
    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 10000845
    E.1.2Term Acute lymphoblastic leukemia
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10009015
    E.1.2Term Chronic myeloid leukemia
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10034877
    E.1.2Term Philadelphia chromosome positive
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of Part C of the study is to:
    • Evaluate the anti-leukemic efficacy of K0706 in subjects with CML-CP by cytogenetic outcomes and in subjects with, AP, BP and Ph+ ALL by hematologic outcomes
    El objetivo principal de la Parte C del estudio es:
    Evaluar la eficacia antileucémica de K0706 en pacientes con LMC-FC por los resultados citogenéticos y en pacientes con LLA en FA, FB y positiva para resultados hematológicos
    E.2.2Secondary objectives of the trial
    The secondary objectives of Part C of the study are to evaluate:
    • Anti-leukemic efficacy of K0706 by molecular outcomes
    • Time to first hematologic response
    • Duration of response
    • Progression free survival (PFS) and Overall survival (OS)
    • Population PK of K0706 with sparse sampling
    • Safety of K0706 in the enrolled subjects
    Los objetivos secundarios de la Parte C del estudio son:
    • La eficacia antileucémica de K0706 por los resultados moleculares
    • El tiempo hasta la primera respuesta hematológica
    • La duración de la respuesta
    • La supervivencia sin progresión (SSP) y la supervivencia general (SG)
    • La FC poblacional de K0706
    • La seguridad de K0706 en los pacientes inscritos
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Part C:
    1.Willing and able to give written/signed, and dated, informed consent (or by legally acceptable representative/impartial witness when applicable) and is available for the entire study
    2.Willing and able to comply with the scheduled visits, treatment plan, laboratory testing, study procedures, and restrictions, and be accessible for follow-up
    3.Subjects with CML in any phase or Ph+ ALL who are resistant and/or intolerant to ≥ 3 prior TKIs or are not eligible for 3rd TKI [e.g.: due to comorbidities, hypersensitivity to excipients, resistance/intolerance to at least 2 TKIs other than imatinib) or the TKIs are ineffective against mutations detected in the patient’s tumor)]
    4.Male or female aged ≥ 18 years
    5.Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
    6.Adequate organ and immune system function as indicated by the following laboratory values obtained ≤ 2 weeks prior to IMP administration.
    7.Subjects of childbearing potential must practice a medically acceptable method of birth control as judged by the Investigator (refer to protocol for details)
    8.Male subjects enrolled in the study should not father a child and are advised to prevent passage of semen to their sexual partner during intercourse using an acceptable method as detailed in the Inclusion criteria # 7 and judged by the Investigator for the duration of the study and for 3 months after the last IMP administration
    9.Female subjects of childbearing potential must have a negative pregnancy test (as confirmed by a negative urine pregnancy test with a sensitivity of less than 50 mIU/mL or equivalent units of human chorionic gonadotropin).
    10.Female subjects should be non-lactating and non-breast-feeding
    Parte C:
    1. Estar dispuesto y tener capacidad para otorgar el consentimiento informado por escrito y fechado (o mediante un representante legal/testigo imparcial cuando proceda) y estar
    disponible durante la totalidad del estudio
    2. Estar dispuesto y tener capacidad para cumplir con las visitas programadas, el plan del
    tratamiento, las pruebas analíticas, los procedimientos y las restricciones del estudio y estar
    accesible para el seguimiento
    3. Los pacientes con LMC en cualquier fase o LLA positiva para el cromosoma Filadelfia que
    son resistentes y/o no toleran ≥3 ITC previos o no son aptos para un 3.erITC(p. ej., debido a
    comorbilidades, hipersensibilidad a los excipientes, la resistencia/intolerancia a al menos 2
    ITC distintos de imatinib o los ITC son ineficaces contra las mutaciones detectadas en el
    tumor paciente)
    4. Varones o mujeres ≥ 18 años de edad
    5. Estado general de 0, 1 o 2 del Grupo oncológico cooperativo del este (ECOG)
    6. Función de los órganos y del sistema inmunitario adecuadas, indicadas por los siguientes
    valores analíticos obtenidos ≤2 semanas antes de la administración de PEI:
    7. Los pacientes en edad fértil deben practicar un método anticonceptivo aceptable desde el
    punto de vista médico (ver protocolo para más detalle)
    8. Los pacientes de sexo masculino incluidos en el estudio no deben engendrar un hijo y se les aconseja evitar la transferencia de semen a su pareja sexual durante las relaciones sexuales
    utilizando un método aceptable tal como se detalla el criterio de inclusión n.º 7 y a criterio del
    investigador durante todo el estudio y durante 3 meses después de la última administración del
    PEI
    9. Las pacientes en edad fértil deben tener un resultado negativo en la prueba de embarazo
    (según lo confirmado por un resultado negativo en la prueba de embarazo en orina con una
    sensibilidad de menos de 50 mUI/ml o unidades equivalentes de gonadotropina coriónica
    humana).
    10. Las pacientes no deben estar en periodo de lactancia y no deben estar dando el pecho
    E.4Principal exclusion criteria
    Part C:
    1.Presence of T315I mutations
    2.Any major surgery, as determined by the Investigator, within 14 days of IMP administration
    3.Inability to swallow oral medication
    4.Evidence of clinically significant organ dysfunction or any clinically relevant deviation from normal in physical examination, ECG findings, vital signs, or clinical laboratory test findings which in the opinion of the investigator may jeopardize the safety of the patient during the study or may interfere with the evaluation of the study medication.
    5.Positive exclusion tests: urine pregnancy tests (if applicable), HIV
    6.History of any relevant allergy/hypersensitivity (including known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the IMP or its excipients)
    7.Known history of active hepatitis B or hepatitis C
    8.Received an investigational agent within 30 days of IMP administration
    9.Subjects on sensitive substrates of CYP2C8 with a narrow therapeutic index, or on strong inhibitors or inducers of major CYP enzymes, should be avoided or used with caution in this trial
    10.Use of concomitant medication that might influence the results of the study prior to IMP administration/or anticipated need any time during the study
    11.Known or suspected history of significant drug or alcohol abuse as judged by the Investigator
    12.Radiotherapy within 21 days or cytotoxic chemotherapy or Vincristine within 7 days (for Ph+ ALL only); interferon or Cytarabine or immunotherapy within 14 days prior to the first IMP administration visit
    13.Active central nervous system (CNS) disease as evidenced by cytology or pathology.
    14.Malabsorption syndrome or other illness that could affect oral absorption of the IMP
    15.Clinically significant, uncontrolled, or active cardiovascular disease
    16.Uncontrolled intercurrent illness
    17.Subjects eligible and willing to undergo bone marrow transplant
    18.Autologous or allogeneic stem cell transplant ≤ 3 months prior to Screening
    19.Another primary malignancy within the past 3 years or earlier.
    20.Any contraindications for repeated bone marrow sample collection
    21.Prior exposure to K0706 therapy as a participant in Part B of the protocol

    Other criteria may apply (refer to protocol)
    Parte C:
    1. Presencia de mutación T315I
    2. Cualquier operación de cirugía mayor, según lo determinado por el investigador, en el plazo
    de 14d antes de la adm del PEI
    3. Incapacidad para tragar la medicación por VO
    4. Evidencia de disfunción orgánica clínicamente significativa o cualquier desviación
    clínicamente relevante respecto a la normalidad en la exploración física, resultados de ECG,
    constantes vitales, o de pruebas analíticas que en opinión del investigador pueda
    poner en peligro la seguridad del paciente durante el estudio o pueda interferir con la
    evaluación del fármaco del estudio.
    5. Resultado+ en las pruebas de exclusión: pruebas de embarazo en orina (si procede),
    VIH
    6. Antecedentes de alergia/hipersensibilidad relevantes (incluidas reacc de hipersensibilidad inmediata o retardada o idiosincrásica a fármacos químicamente relacionados con el PEI o con sus excipientes)
    7. Antecedentes conocidos de hepatitis B o C activa
    8. Haber recibido un fármaco en investigación en los 30d previos a la adm del PEI
    9. Los pacientes que tomen sustratos del CYP2C8 sensibles con un índice terapéutico estrecho, o inhibidores o inductores potentes de las ppales enzimas de CYP deben evitarlos o
    emplearlos con precaución en este ensayo
    10. Uso de medicación concomitante que podría influir en los resultados del estudio antes de la
    adm del PEI o necesidad prevista en cualquier momento durante el estudio
    11. Antecedentes conocidos o sospecha de antecedentes de abuso de drogas o alcohol
    significativo a criterio del investigador
    12. Radioterapia o quimioterapia citotóxica en un plazo de 21 días o vincristina en un plazo de 7 días (para la LLA positiva para el cromosoma
    Ph solamente); interferón o citarabina o inmunoterapia en los 14 días anteriores a la
    primera visita de administración del PEI
    13. Enfermedad activa del sistema nervioso central (SNC) demostrada mediante citología o
    informe patológico
    14. Síndrome de malabsorción u otra enfermedad que pueda afectar a la absorción oral del PEI
    15. Tener una enfermedad cardiovascular clínicamente significativa, incontrolada o activa
    16. Enfermedades intercurrentes no controladas
    17. Los pacientes deben ser aptos y estar dispuestos a someterse a un trasplante de médula ósea
    18. Trasplante autógeno o alotrasplante de células madre ≤3 m antes de la selección
    20. Otra neoplasia maligna primaria en los últimos 3a o más
    21. Cualquier contraindicación para la repetición de la recogida de muestra de médula ósea
    22. Exposición previa al tto con K0706 como participante en la parte B del protocolo.

    Otros criterios pueden aplicar (refiérase al protocolo)
    E.5 End points
    E.5.1Primary end point(s)
    Part C
    In subjects with CML-CP:
    - Major Cytogenetic Response (MCyR) rate (defined as the proportion of subjects who achieve a Complete Cytogenetic Response [CCyR]), or Partial Cytogenetic Response (PCyR) after the initiation of study treatment
    - For subjects entering the study in MCyR, it is defined as the proportion of subjects who maintain the MCyR after initiation of study treatment upto 24 weeks on study treatment

    In subjects with CML-AP or CML-BP or Ph+ALL
    - Major Hematologic Response (MaHR) rate (defined as the proportion of subjects who achieve a Complete Hematologic Response [CHR]), or No Evidence of Leukemia (NEL) response after the initiation of treatment,
    - For subject entering the study in MaHR, it is defined as the proportion of subjects who maintain the MaHR after initiation of study treatment upto 12 weeks on study treatment
    Parte C
    En pacientes con LMC-FC:
    oTasa de respuesta citogenética mayor (RCgM) (que se define como la proporción de pacientes que logran una respuesta citogenética completa [RCgC]) o de respuesta citogenética parcial (RCgP) después del inicio del tratamiento del estudio
    oPara los pacientes que entren en el estudio con RCgM, se define como la proporción de pacientes que mantienen la RCgM después del inicio del tratamiento del estudio hasta 24 semanas en el tratamiento del estudio
    En pacientes con LMC-FA o LMC-FB o LLA Ph+:
    oTasa de respuesta hematológica mayor (RHM) (que se define como la proporción de pacientes que logran una respuesta hematológica completa [RHC]) o respuesta sin evidencia de leucemia (SEL) tras el inicio del tratamiento
    oPara los pacientes que entren en el estudio con RHM, se define como la proporción de pacientes que mantienen la RHM después del inicio del tratamiento del estudio hasta 12 semanas en el tratamiento del estudio
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throghout the study duration
    Durante toda la duración del estudio
    E.5.2Secondary end point(s)
    Part C:
    • In subjects with CML-CP
    - Hematological responses: Proportion of subjects who achieve or maintain complete hematological response
    - Molecular responses: Proportion of subjects who achieve or maintain MMR
    • In subjects with CML-AP or CML-BP or Ph+ALL
    - Cytogenetic responses: Proportion of subjects who achieve CCyR, PCyR, confirmed MCyR
    - Molecular responses: Proportion of subjects who achieve or maintain MMR
    • In all subjects: Safety and tolerability in terms of incidence and severity of treatment emergent AEs
    • In all subjects: Time to response, duration of response, PFS and OS
    Parte C
    •En pacientes con LMC-FC:
    - Respuestas hematológicas: proporción de pacientes que logran o mantienen la respuesta hematológica completa
    - Respuestas moleculares: proporción de pacientes que logran o mantienen la RMM
    • En pacientes con LMC-FA o LMC-FB o LLA Ph+:
    - Respuestas citogenéticas: proporción de pacientes que logran la RCgC, la RCgP o la RCgM confirmada
    - Respuestas moleculares: proporción de pacientes que logran o mantienen la RMM
    • En todos los pacientes: seguridad y tolerabilidad en términos de incidencia e intensidad de los AA surgidos durante el tratamiento
    En todos los pacientes: tiempo hasta la respuesta, duración de la respuesta, SSP y SG
    E.5.2.1Timepoint(s) of evaluation of this end point
    For Part C: throghout the study duration
    Para la Parte C: durante toda la duración del estudio
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Part C: to evaluate the antileukemic efficacy
    Parte C: para evaluar la eficacia antileucémica.
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned8
    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
    France
    Germany
    Hungary
    Italy
    Korea, Republic of
    Poland
    Romania
    Russian Federation
    Spain
    Thailand
    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
    LPLV
    UPUV
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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: 42
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 41
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 51
    F.4.2.2In the whole clinical trial 89
    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)
    After a subject has completed the study or has withdrawn early from the study, usual treatment (as per the local standards of care) will be administered, if required, in accordance with the study center’s generally accepted medical practice and depending on the subject’s individual medical needs. The Sponsor will not have any role to play in further treatment and the treatment regimen followed will be outside the purview of the study protocol.
    Después de que un sujeto haya completado el estudio o se haya retirado temprano del estudio, se administrará el tratamiento habitual (según los estándares locales de atención), si es necesario, de acuerdo con la práctica médica generalmente aceptada del centro del estudio y dependiendo de la medicina individual del sujeto. El patrocinador no tendrá ningún papel que desempeñar en el tratamiento posterior y el régimen de tratamiento seguido estará fuera del alcance del protocolo del estudio
    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 Decision2019-09-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-25
    P. End of Trial
    P.End of Trial StatusOngoing
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