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    Summary
    EudraCT Number:2010-024473-39
    Sponsor's Protocol Code Number:CINC424A2401
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-07-07
    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 number2010-024473-39
    A.3Full title of the trial
    Ensayo clínico abierto, multicéntrico, de acceso expandido de INC424 en pacientes con mielofibrosis primaria (PMF) o mielofibrosis secundaria a policitemia (PPV MF) o mielofibrosis secundaria a trombocitemia esencial (PET-MF)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Estudio de seguridad y eficacia de INC424 en pacientes con mielofibrosis.
    A.3.2Name or abbreviated title of the trial where available
    not available
    A.4.1Sponsor's protocol code numberCINC424A2401
    A.5.4Other Identifiers
    Name:NANumber:NA
    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 SponsorNovartis Farmacéutica, S.A.
    B.1.3.4CountrySpain
    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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNOVARTIS FARMACÉUTICA S.A.
    B.5.2Functional name of contact pointDRA
    B.5.3 Address:
    B.5.3.1Street AddressC/ GRAN VIA DE LES CORTS CATALANES 764
    B.5.3.2Town/ cityBARCELONA
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number0034933064316
    B.5.5Fax number0034933064290
    B.5.6E-mailmarta.olivan@novartis.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 numberEU/3/08/572 y EU/3/09/620
    D.3 Description of the IMP
    D.3.1Product nameruxolitinib
    D.3.2Product code INC424
    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 INNRuxolitinib
    D.3.9.2Current sponsor codeINC424
    D.3.9.3Other descriptive nameINCB018424
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    Mielofibrosis primaria (MFP), mielofibrosis post-policitemia vera (MF PPV) o mielofibrosis post-trombocitemia esencial (MF PTE).
    E.1.1.1Medical condition in easily understood language
    Mielofibrosis
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10028537
    E.1.2Term Myelofibrosis
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Recoger datos de seguridad adicional de INC424 en pacientes con PMF, PPV MF o PET-MF, que hayan recibido tratamiento previo con agentes disponibles comercialmente o que nunca hayan recibido tratamiento.
    E.2.2Secondary objectives of the trial
    *Documentar la mejor tasa de respuesta global para INC424 en pacientes con PMF, PPV MF o PET-MF, determinado por el investigador.
    *Recoger variables de calidad de vida (QoL)
    *Documentar la utilización de recursos clínicos
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Los pacientes deberán proporcionar el consentimiento informado por escrito según las pautas locales antes de cualquier procedimiento de selección.
    2.Los pacientes no deberán ser elegibles paraotro ensayo clínico en curso con INC424.
    3.Pacientes hombres o mujeres con 18 años de edad.
    4.Pacientes con diagnóstico de PMF, PPV-MF o PET-MF, según los criterios de la Organización Mundial de la Salud 2008
    5.Los pacientes con PMF que precisen terapia deberá ser clasificados como nivel de riesgo alto (3 factores pronóstico) O nivel de riesgo intermedio 2 (2 factores pronóstico, no más) O nivel de riesgo intermedio 1 (1 factor pronóstico, no más) con aumento de tamaño del bazo.
    6.Los pacientes con enfermedad con nivel de riesgo intermedio-1 y esplenomegalia, deberán presentar un bazo palpable que mida 5 cm o más desde el reborde costal hasta el punto de mayor protrusión esplénica.
    E.4Principal exclusion criteria
    1.Pacientes elegibles para trasplante de células madre hematopoyéticas
    2.Pacientes con antecedentes de enfermedad maligna en los últimos 3 años, excepto carcinoma in situ
    3.Pacientes en tratamiento con agonistas del receptor del factor de crecimiento hematopoyético, factor estimulante de colonias de granulocitos en cualquier momento dentro de las 2 semanas previas a la selección o 4 semanas antes de la visita basal.
    4.Pacientes que actualmente participen en los ensayos COMFORT-I y COMFORT-II
    5.Pacientes que reciban cualquier medicación listada en la lista de medicaciones prohibidas
    6.Deterioro de la función gastrointestinal (GI) o enfermedad GI que pueda alterar significativamente la absorción de INC424
    7.Pacientes con enfermedad cardíaca, que a criterio del investigador, pueda poner en peligro la seguridad del paciente
    8.Pacientes con angina inestable o incontrolada actualmente, fibrilación auricular paroxística o rápida o infarto de miocardio reciente o síndrome coronario agudo.
    9.Pacientes con infecciones víricas clínicamente significativas (para más detalles ver protocolo)
    10.Pacientes con hepatitis A, B, C activa o VIH-positivos
    11.Pacientes con parámetros de coagulación
    12.Mujeres embarazadaso en periodo de lactancia
    E.5 End points
    E.5.1Primary end point(s)
    SEGURIDAD:
    *Se recogerán los parámetros clínicos y de laboratorio para evaluar la seguridad del medicamento en estudio y la toxicidad.
    La tolerabilidad y la seguridad se recogerán monitorizando la frecuencia, duración y severidad de todos los acontecimientos adversos (AEs)con el CTCAE v. 3.0, realizando exámenes físicos (PE), y evaluando cambios en las constantes vitales (VS), estado funcional del ECOG (PS), ECGs y los resultados hematológicos y bioquímicas.
    *AAs de grado 3 y 4, acontecimientos adversos graves (AAGs)
    *Frecuencia de interrupciones de dosis y discontinuaciones debido a AEs
    E.5.1.1Timepoint(s) of evaluation of this end point
    Mensual para los 3 primeros meses, desde entonces cada 3 meses y en la discontinuación del estudio.
    E.5.2Secondary end point(s)
    Calidad de vida:
    - Cambio en el ECOG PS desde la visita basal
    -cambio en el FACT-Lym
    - cambio en la evaluación funcional de tratamientos crónicos
    E.5.2.1Timepoint(s) of evaluation of this end point
    Mensual para los 3 primeros meses, desde entonces cada 3 meses y en la discontinuación 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 No
    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 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 No
    E.8.1.1Randomised No
    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 No
    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 concerned44
    E.8.5The trial involves multiple Member States No
    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
    Argentina
    Brazil
    Canada
    Colombia
    Korea, Republic of
    Lebanon
    Mexico
    Russian Federation
    Saudi Arabia
    Singapore
    South Africa
    Switzerland
    Taiwan
    Venezuela, Bolivarian Republic of
    E.8.7Trial has a data monitoring committee No
    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
    Última visita último paciente (UVUP)
    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: 0
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 0
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state80
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 950
    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)
    Ver sección 6.1.2 (página 53) del protocolo del ensayo.
    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 Decision2011-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-02-09
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