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    The EU Clinical Trials Register currently displays   44336   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2009-017918-69
    Sponsor's Protocol Code Number:AB08026
    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:2010-11-26
    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 number2009-017918-69
    A.3Full title of the trial
    ESTUDIO PROSPECTIVO, MULTICÉNTRICO, ALEATORIZADO, ABIERTO, CONTROLADO CON FARMACO ACTIVO, DE GRUPOS PARALELOS, FASE 3, PARA COMPARAR LA EFICACIA Y SEGURIDAD DE MASITINIB A LA DOSIS DE 7,5 MG / KG / DÍA CON DACARBAZINA EN EL TRATAMIENTO DE PACIENTES CON MELANOMA METASTASICO NO RESECABLE DE GRADO 3 O 4 CON UNA MUTACION EN EL DOMINIO JUXTAMEMBRANA DE C-KIT
    A.4.1Sponsor's protocol code numberAB08026
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAB Science
    B.1.3.4CountryFrance
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 namemasitinib
    D.3.2Product code AB1010
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNMasitinib mesylate
    D.3.9.1CAS number 790-299-79-5
    D.3.9.2Current sponsor codeAB1010
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number119
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeInhibidor de la tirosin quinasa
    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 namemastinib
    D.3.2Product code AB1010
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNMasitinib mesylate
    D.3.9.1CAS number 790-299-79-5
    D.3.9.2Current sponsor codeAB1010
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number238
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeInhibidor de la tirosin quinasa
    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
    Pacientes diagnosticados de melanoma metastático no resecable de grado 3 o 4 con una mutación en el dominio juxtamembrana c-kit
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10025670
    E.1.2Term Malignant melanoma stage III
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10025671
    E.1.2Term Malignant melanoma stage IV
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo es comparar la eficacia y seguridad de masitinib a la dosis 7,5 mg / kg / día con dacarbazina para el tratamiento de pacientes con melanoma metastático no resecable de grado 3 ó 4 con una mutación en el dominio juxtamembrana de c-kit.
    o Supervivencia libre de progresión (SLP)
    E.2.2Secondary objectives of the trial
    o Supervivencia global (SG)
    o Tasa de supervivencia en las semanas 6, 12, 18, 24 y cada 12 semanas
    Evaluación del tumor
    o Tasa de SLP en las semanas 6, 12, 18, 24 y cada 12 semanas
    o Tiempo hasta la progresión (TP)
    o Tasa de TP en las semanas 6, 12, 18, 24 y cada 12 semanas
    o Mejor respuesta, tasa de respuesta objetiva (RC + RP) y control de enfermedad (RC + RP + EE)
    Calidad de Vida en las semanas 6, 12, 18 y 24 y cada 12 semanas
    o Estado funcional ECOG
    o EORTC QLQ-C30
    Perfil de seguridad usando la clasificación NIC CTCAE v4.0
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Pacientes 18 años de edad, hombre o mujer, con un peso superior a 40 kg
    2. Paciente diagnosticado histológica o citológicamente de melanoma metastático estadío 3 (no resecable IIIB ó IIIC, sistema de estadificación AJCC/TNM, 7 ª edición) o estadío 4
    3. Paciente con mutación c kit JM detectable confirmada por secuenciación de ADN o ARN, que se espera que se encuentren sobre todo después de su exámen de la mucosa o melanoma acral o melanoma en la piel con daños crónicos inducidos por el sol (definida por una marcada elastosis al microscopio que abarca la piel que rodea el melanoma primario)
    4. Pacientes con enfermedad medible de acuerdo a RECIST
    5. Pacientes con ECOG menor o igual que 2
    6. Pacientes con esperanza de vida mayor o igual que 12 semanas
    7. Pacientes con una adecuada función de los órganos:
    Recuento absoluto de neutrófilos (RAN) mayor o igual que 1,5 x 109/L
    Hemoglobina mayor o igual que 10 g/dL
    Plaquetas (PLT) mayor o igual que 100 x 10 9 / L
    AST/ALT menor o igual que 2,5 x LSN ( 5 x LSN en caso de metástasis hepáticas)
    Bilirrubina menor o igual que 1,5 x LSN ( 3 x LSN en caso de metástasis hepáticas)
    Aclaramiento de creatinina mayor o igual que 50 ml/min (fórmula Cockcroft y Gault)
    Albuminemia mayor o igual que 0,75 x LIN
    Urea menor o igual que 2 x LSN
    Proteinuria <30 mg/dL en la tira reactiva, en caso de proteinuria mayor o igual que 30 mg/dL, proteinuria de 24 horas menor o igual que 1,5 g/24 h
    8. Los hombres y mujeres en edad fértil (éstas entrarán en el estudio después de un período menstrual y con una prueba de embarazo negativa) deben utilizar dos métodos anticonceptivos aceptados (uno para el paciente y otro para la pareja) durante el estudio y 3 meses después de la última dosis de tratamiento.
    9. El paciente debe ser capaz y estar dispuesto a cumplir con los procedimientos del estudio según el protocolo.
    10. El paciente debe ser capaz de entender, firmar y fechar voluntariamente el consentimiento informado en la visita de selección antes de que se realice cualquier procedimiento específico del protocolo
    E.4Principal exclusion criteria
    1. Mujeres embarazadas o en período de lactancia
    2. Pacientes con otros tumores malignos pero que esté libre de enfermedad hace menos de 3 años, con excepcion del melanoma, carcinoma cervical in situ, de células basales o de células de cáncer de piel escamosa, carcinoma in situ de mama ductal o lobulillar
    3. Pacientes con metástasis cerebrales activas. Los pacientes con metástasis cerebrales tratados son elegibles si:
    (A) presencia de 3 o menos lesiones cerebrales
    (B) lesión (s) de diámetro menor o igual que 2 cm
    (C) radioterapia (bisturí de rayos gamma) finalizada mayor o igual que 4 semanas antes de la visita basal
    (D) la cirugía se realizó mayor o igual que 4 semanas antes de la visita basal
    (E) las lesiones evaluadas por tomografía de seguimiento (o resonancia magnética si se hizo resonancia magnética del cerebro antes del tratamiento) mayor o igual que 1 mes después de la terapia están controladas al inicio del estudio
    4. Pacientes refractarios a la dacarbazina definida como pacientes que presentan una progresión de la enfermedad después de 3 meses de tratamiento con dacarbazina.
    5. El tratamiento previo con un inhibidor de la tirosin quinasa c-kit
    6. Pacientes con problemas cardíacos grado III / IV según la definición de la New York Heart Association Criteria (es decir, la insuficiencia cardíaca congestiva, infarto de miocardio dentro de los seis meses anteriores a la visita basal)
    7. Pacientes con enfermedades infecciosas no controladas clínicamente, incluido el VIH o enfermedades relacionadas con el SIDA
    8. Cirugía mayor o radioterapia en las cuatro semanas anteriores al inicio del tratamiento en estudio
    9. Pacientes con una historia de pobre cumplimiento o de abuso de drogas o alcohol, o consumo excesivo de bebidas alcohólicas que pudiera interferir con la capacidad de cumplir con el protocolo del estudio, o enfermedad psiquiátrica actual o pasada que pueda interferir con la capacidad de cumplir con el protocolo o de dar su consentimiento informado
    E.5 End points
    E.5.1Primary end point(s)
    Supervivencia libre de progresión (SLP) se define como el tiempo transcurrido desde la fecha de la aleatorización hasta la fecha de la progresión documentada (según m-RECIST) o cualquier otra causa de muerte durante el 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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    E.8.2.3.1Comparator description
    Dacarbazine
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Hasta la progresión de la enfermedad sin beneficio clínico, toxicidad limitante o retirada del consentimiento informado.
    Más información en el protocolo.
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 200
    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 Decision2011-01-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-04-19
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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