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    Summary
    EudraCT Number:2012-001355-38
    Sponsor's Protocol Code Number:AP24534-12-301
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-10-02
    Trial results View 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 number2012-001355-38
    A.3Full title of the trial
    A Phase 3 Randomized, Open-Label Study of Ponatinib versus Imatinib in Adult Patients with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
    Estudio Fase III, aleatorizado, abierto de Ponatinib frente a Imatinib en pacientes adultos con Leucemia Mieloide Crónica de nuevo diagnóstico en Fase Crónica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Not applicable
    A.3.2Name or abbreviated title of the trial where available
    Not applicable
    A.4.1Sponsor's protocol code numberAP24534-12-301
    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 SponsorARIAD Pharmaceuticals, Inc
    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 supportARIAD Pharmaceuticals, Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationARIAD Pharmaceuticals, Inc
    B.5.2Functional name of contact pointBao Le
    B.5.3 Address:
    B.5.3.1Street Address26 Landsdowne Street
    B.5.3.2Town/ cityCambridge, MA
    B.5.3.3Post code02139
    B.5.3.4CountryUnited States
    B.5.6E-mailbao.le@ariad.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberC (2010) 789
    D.3 Description of the IMP
    D.3.1Product namePonatinib
    D.3.2Product code AP24534
    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 INNponatinib
    D.3.9.1CAS number 943319-70-8
    D.3.9.2Current sponsor codeAP24534 HCI
    D.3.9.3Other descriptive namePONATINIB
    D.3.9.4EV Substance CodeSUB31624
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number45
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Glivec
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGlivec
    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 INNimatinib
    D.3.9.1CAS number 152459-95-5
    D.3.9.3Other descriptive nameIMATINIB
    D.3.9.4EV Substance CodeSUB25387
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 Yes
    D.2.5.1Orphan drug designation numberC (2010) 789
    D.3 Description of the IMP
    D.3.1Product namePonatinib
    D.3.2Product code AP24534
    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 INNponatinib
    D.3.9.1CAS number 943319-70-8
    D.3.9.2Current sponsor codeAP24534 HCI
    D.3.9.3Other descriptive namePONATINIB
    D.3.9.4EV Substance CodeSUB31624
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 Glivec
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGlivec
    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 INNimatinib
    D.3.9.1CAS number 152459-95-5
    D.3.9.3Other descriptive nameIMATINIB
    D.3.9.4EV Substance CodeSUB25387
    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.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 in Chronic Phase
    Leucemia Mieloide Crónica en Fase Crónica
    E.1.1.1Medical condition in easily understood language
    not applicable
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of ponatinib with imatinib as measured by major molecular response (MMR) rate at 12 months (1 month or cycle = 28 days)
    Comparar la eficacia de Ponatinib con Imatinib medida a través de la tasa de respuesta molecular mayor (RMM) a los 12 meses (1 mes o ciclo = 28 días).
    E.2.2Secondary objectives of the trial
    ? To compare, according to treatment with ponatinib versus imatinib, MMR rate at 5 years
    ?To compare the proportion of patients achieving a ratio of <10% BCR-ABL to ABL transcript levels at 3 months, as measured by the international scale (<10% BCR-ABLIS), in patients administered ponatinib versus those administered imatinib
    ? To compare, according to treatment with ponatinib versus imatinib, the complete cytogenetic response (CCyR) rate at 12 months
    ? To compare, according to treatment with ponatinib versus imatinib, progression-free survival and overall survival
    Other secondary and exploratory study objectives as listed in the protocol
    -Comparar, según el tratamiento con Ponatinib frente a Imatinib, la tasa de RMM a los 5 años.
    -Comparar el porcentaje de pacientes que logran un cociente < 10% en los niveles de transcriptos de BCR-ABL con respecto a ABL a los 3 meses, medida mediante la escala internacional (BCR-ABLIS < 10%) en los pacientes tratados con Ponatinib frente a los tratados con Imatinib.
    -Comparar, según el tratamiento con Ponatinib frente a Imatinib, la respuesta citogenética completa (RCiC) a los 12 meses.
    -Comparar, según el tratamiento con Ponatinib frente a Imatinib, la supervivencia sin progresión y la supervivencia global.
    Otros objetivos secundarios y exploratorios se presentan en el protocolo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients ?18 years old
    2. CP-CML within 6 months of diagnosis
    3. Cytogenetic assessment must demonstrate the BCR-ABL fusion by presence of the t(9;22) Philadelphia chromosome
    4. ECOG Performance Status of 0, 1, or 2
    5. Adequate hepatic function as defined in the protocol
    6. Adequate renal function as defined in the protocol
    7. Adequate pancreatic function as defined in the protocol
    8. For females of childbearing potential, a negative pregnancy test must be documented prior to randomization
    9. Female and male patients who are of childbearing potential must agree to use
    an effective form of contraception with their sexual partners from
    randomization through 30 days after the end of treatment
    10. Provide written informed consent
    11. Willingness and ability to comply with scheduled visits and study procedures
    1. Pacientes de ambos sexos ? 18 años de edad
    2. LMC- FC en los 6 meses posteriores al diagnóstico
    3. La evaluación de marcadores citogenéticos debe demostrar la fusión de BCR- ABL mediante presencia del cromosoma Filadelfia t(9;22)
    4. Estado funcional según la escala ECOG de 0, 1 o 2
    5. Función hepática adecuada, tal como la define el protocolo
    6. Función renal adecuada, tal como la define el protocolo
    7. Función pancreática adecuada, tal como la define el protocolo
    8. En mujeres en edad fértil debe confirmarse una prueba de embarazo negativa antes de la aleatorización
    9. Los pacientes de ambos sexos en edad fértil deben aceptar usar un método anticonceptivo eficaz con sus parejas sexuales desde la aleatorización hasta 30 días después del final del tratamiento.
    10. Obtención del consentimiento informado por escrito
    11. Disposición y capacidad para cumplir con las visitas programadas y los procedimientos del estudio
    E.4Principal exclusion criteria
    1. Received prior imatinib therapy
    2. Received prior dasatinib therapy
    3. Received prior nilotinib therapy
    4. Received, for CML, any other systemic anticancer therapy, experimental
    therapy, or radiation therapy with the exception of anagrelide or hydroxyurea
    5. Major surgery within 28 days prior to initiating therapy
    6. History of bleeding disorder unrelated to CML
    7. History of acute pancreatitis within 1 year of study or history of chronic
    pancreatitis
    8. History of alcohol abuse
    9. Have uncontrolled hypertriglyceridemia (triglycerides >450 mg/dL)
    10. Significant uncontrolled or active cardiovascular disease
    11. Uncontrolled hypertension (diastolic blood pressure >100 mm Hg; systolic
    >150 mm Hg)
    12. Taking medications that are known to be associated with Torsades de Pointes
    (Appendix A)
    13. Ongoing or active infection. The requirement for intravenous (IV) antibiotics
    is considered active infection
    14. Known history of human immunodeficiency virus (HIV). Testing is not
    required in the absence of history
    15. Pregnant or breastfeeding
    16. Malabsorption syndrome or other gastrointestinal illness that could affect oral
    absorption of study drugs
    17. Diagnosed with or received anticancer therapy for another primary
    malignancy within 3 years prior to entry (except for non-melanoma skin
    cancer or cervical cancer in situ)
    18. Any condition or illness that, in the opinion of the Investigator, would
    compromise patient safety or interfere with the evaluation of the drug
    1. Haber recibido previamente tratamiento con Imatinib
    2. Haber recibido previamente tratamiento con dasatinib
    3. Haber recibido previamente tratamiento con nilotinib
    4. Haber recibido, para la LMC, cualquier otro tratamiento antineoplásico sistémico, tratamiento experimental o radioterapia con la excepción de anagrelida o hidroxiurea
    5. Cirugía mayor en los 28 días previos al inicio del tratamiento
    6. Antecedentes de trastorno hemorrágico no relacionado con la LMC
    7. Antecedentes de pancreatitis aguda en el año previo al estudio o antecedentes de pancreatitis crónica
    8. Antecedentes de consumo de alcohol
    9. Hipertrigliceridemia no controlada (triglicéridos > 450 mg/dl)
    10. Enfermedad cardiovascular activa o no controlada significativa
    11. Hipertensión no controlada (presión arterial diastólica > 100 mm Hg; presión arterial sistólica > 150 mm Hg)
    12. Toma de medicamentos que se sabe que se asocian a Torsades de pointes (Anexo A)
    13. Infección activa o en curso. La necesidad de antibióticos intravenosos (i.v.) se considera infección activa.
    14. Antecedentes conocidos de virus de la inmunodeficiencia humana (VIH). Las pruebas no son necesarias en ausencia de antecedentes.
    15. Embarazo o lactancia
    16. Síndrome de malabsorción u otras enfermedades gastrointestinales que puedan afectar a la absorción oral de los fármacos del estudio
    17. Diagnostico de otra neoplasia maligna primaria o haber recibido tratamiento antineoplásico para ella en los 3 años anteriores a la inclusión en el estudio (excepto para cáncer de piel no-melanoma o cáncer cervicouterino in situ)
    18. Cualquier afección o enfermedad que, en opinión del investigador, pueda poner en peligro la seguridad del paciente o interferir en la evaluación del fármaco
    E.5 End points
    E.5.1Primary end point(s)
    MMR rate at 12 months (1 month or cycle = 28 days)
    Tasa de RMM a los 12 meses (1 mes o ciclo = 28 días).
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 meses
    E.5.2Secondary end point(s)
    Key secondary endpoints:
    1 MMR rate at 5 years
    2 <10% BCR-ABLIS rate at 3 months
    3 CCyR rate at 12 months
    4 Progression-free survival
    5 Overall survival
    Other Secondary Endpoints as listed in the protocol
    Principales criterios secundarios de valoración
    1.Tasa de RMM a los 5 años
    2.Tasa de BCR-ABLIS < 10% a los 3 meses
    3.Tasa de RCiC a los 12 meses
    4.Supervivencia sin progresión
    5.Supervivencia global
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 MMR rate at 5 years
    2 <10% BCR-ABLIS rate at 3 months
    3 CCyR rate at 12 months
    1.Tasa de RMM a los 5 años
    2.Tasa de BCR-ABLIS < 10% a los 3 meses
    3.Tasa de RCiC a los 12 meses
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA82
    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
    Czech Republic
    Denmark
    Finland
    France
    Germany
    Hong Kong
    Ireland
    Israel
    Italy
    Korea, Republic of
    Netherlands
    New Zealand
    Norway
    Poland
    Portugal
    Singapore
    Slovakia
    South Africa
    Spain
    Sweden
    Switzerland
    Taiwan
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    Última visita del último paciente que entró en el estudio
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    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 years10
    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: 368
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 160
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 254
    F.4.2.2In the whole clinical trial 528
    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)
    ARIAD will cover the cost of both ponatinib and imatinib for the duration of the trial as specified in the protocol. Following discontinuation of the trial, costs for continuing care will be the responsibility of the patient or healthcare.
    ARIAD cubrirá los costes de ponatinib e imatinib durante la duración del ensayo, tal como especifica el protocolo. En los casos de abandono del ensayo, los costes de la atenci´´on serán responsabilidad del paciente o del Sistema de Salud
    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 Decision2012-11-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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