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    Summary
    EudraCT Number:2011-001897-25
    Sponsor's Protocol Code Number:EFC12153
    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:2011-09-20
    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 number2011-001897-25
    A.3Full title of the trial
    A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study of SAR302503 in Patients with Intermediate-2 or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis with Splenomegaly
    Estudio de fase 3, multicéntrico, aleatorizado, doble ciego, controlado con placebo y con 3 grupos, de SAR302503 en pacientes con mielofibrosis primaria, mielofibrosis tras policitemia vera o mielofibrosis tras trombocitemia esencial, de riesgo intermedio de nivel 2 o alto y que presentan esplenomegalia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 3 Study of SAR302503 in Intermediate-2 and High risk patients with Myelofibrosis de riesgo intermedio de nivel 2 o alto
    Estudio fase 3 con SAR302503 en pacientes con mielofibrosis
    A.4.1Sponsor's protocol code numberEFC12153
    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 Sponsorsanofi-aventis recherche & développement
    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 supportsanofi-aventis recherche & développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationsanofi-aventis
    B.5.2Functional name of contact pointRegulatory
    B.5.3 Address:
    B.5.3.1Street Address1 Avenue Pierre Brossolette
    B.5.3.2Town/ cityChilly-Mazarin
    B.5.3.3Post code91385
    B.5.3.4CountryFrance
    B.5.4Telephone number+33(0)158 93 31 98
    B.5.5Fax number+33(0)158 93 20 12
    B.5.6E-mailedwige.mevel@sanofi-aventis.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/3/10/810 and EU/3/10/811 and EU/3/10/794
    D.3 Description of the IMP
    D.3.2Product code SAR302503
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.2Current sponsor codeSAR302503
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    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
    Primary myelofibrosis, post-polycythemia vera myelofibrosis, or post- essential thrombocythemia myelofibrosis
    mielofibrosis primaria, mielofibrosis tras policitemia vera o mielofibrosis tras trombocitemia esencial
    E.1.1.1Medical condition in easily understood language
    blood disorder in which the bone marrow makes too many red blood
    cells, or blood disorder in which the bone marrow makes too many
    platelets
    Enfermedad de la sangre en la cual la médula osea produce demasiadas glóbulos rojos, o enfermedad de la sangre en la que la médula osea produce demasiadas plaquetas
    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 14.0
    E.1.2Level LLT
    E.1.2Classification code 10018864
    E.1.2Term Haematopoietic neoplasm NOS
    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
    To evaluate the efficacy of daily oral doses of 400 mg or 500 mg of SAR302503 (Investigational Medicinal Product, IMP) compared to placebo in the reduction of spleen volume as determined by magnetic resonance imaging (MRI) (or computed tomography scan in patients with contraindications for MRI).
    Evaluar la eficacia de dosis orales diarias de 400 mg o 500 mg de SAR302503 (producto en investigación, PEI) en comparación con placebo en la disminución del volumen esplénico determinado mediante resonancia magnética nuclear (RMN) (o mediante tomografía axial computarizada en los pacientes en los que esté contraindicada la RMN).
    E.2.2Secondary objectives of the trial
    To evaluate the effect on Myelofibrosis (MF)-associated symptoms (key MF symptoms) as measured by the modified Myelofibrosis Symptom Assessment Form (MFSAF) diary.
    To evaluate the Overall Survival of patients treated with either 400 mg/day or 500 mg/day of IMP as compared to placebo.
    To evaluate the Progression Free Survival of patients treated with either 400 mg/day or 500 mg/day of IMP as compared to placebo.
    To evaluate the durability of splenic response.
    To evaluate the safety of IMP.
    Evaluar el efecto sobre los síntomas asociados a la mielofibrosis (MF) (síntomas principales de la MF) medido mediante el diario del Formulario modificado de evaluación de los síntomas de la mielofibrosis (Myelofibrosis Symptom Assessment Form, MFSAF).
    Evaluar la supervivencia global (SG) de los pacientes tratados con 400 mg/día o 500 mg/día del PEI en comparación con placebo.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Full title : A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study of SAR302503 in Patients with Intermediate-2 or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis with Splenomegaly Date : 26 July 2011
    Version : 1
    Protocol : section 9.5 pharmacogenetics
    Objectives : pharmacogenetics explores the effect of genes on the variability of drug responses and/or drug metabolism among people taking the same medicine
    Título completo: Estudio de fase 3, multicéntrico, aleatorizado, doble ciego, controlado con placebo y con 3 grupos, de SAR302503 en pacientes con mielofibrosis primaria, mielofibrosis tras policitemia vera o mielofibrosis tras trombocitemia esencial, que presentan esplenomegalia
    Fecha 26 de julio de 2011-08-31 Versión 1
    Protocol: sección 9.5 Farmacogenética
    Objetivo: La farmacogenética investiga el efecto de los genes en la variabilidad de la respuesta y/o metabolismo de los fármacos entre los sujetos que toman la misma medicina.
    E.3Principal inclusion criteria
    Diagnosis of Primary Myelofibrosis (MF) or Post-Polycythemia Vera MF or Post-Essential Thrombocythemia MF, according to the 2008 World Health Organization and International Working Group of Myelofibrosis Research and Treatment (IWG-MRT) criteria.
    MF classified as high-risk or intermediate-risk level 2, as defined by modified IWG-MRT criteria.
    Enlarged spleen, palpable at least 5 cm below costal margin.
    At least 18 years of age.
    Eastern Cooperative Oncology Group performance status of 0, 1, or 2 at study entry.
    The following laboratory values within 14 days prior to the initiation of IMP or placebo:
    Absolute Neutrophil Count (ANC) ?1.0 x 10exp9/L
    Platelet count ?50 x 10exp9/L
    Serum creatinine ?1.5 x Upper Limit of Normal (ULN)
    Serum amylase and lipase ?1.5 x ULN
    Direct bilirubin ?2.0 x ULN
    Aspartate aminotransferase or alanine aminotransferase ?3 x ULN; higher values (ie, ?5 x ULN) are allowed if clinically compatible with hepatic extramedullary hematopoiesis.
    I 01. Diagnóstico de MFP o MF tras PV o MF tras TE, según los criterios de 2008 de la Organización Mundial de la Salud y el Grupo IWG-MRT.
    I 02. Mielofibrosis (MF) de riesgo alto o de riesgo intermedio de nivel 2, definido según los criterios modificados del Grupo IWG-MRT.
    I 03. Agrandamiento del bazo, palpable el menos 5 cm por debajo del margen costal.
    I 04. Tener como mínimo 18 años.
    I 05. Estado funcional (EF) de 0, 1 ó 2 en el momento de la inclusión en el estudio según la escala del Eastern Cooperative Oncology Group.
    I 06. Los siguientes valores analíticos en los 14 días previos al inicio del tratamiento con el PEI o placebo:
    - RAN ? 1,0 x 109/l
    - Recuento de plaquetas ? 50 x 109/l
    - Creatinina sérica ? 1,5 x LSN
    - Amilasa y lipasa sérica ? 1,5 x LSN
    I 07. Bilirrubina directa ? 2,0 x LSN
    I 08. Aspartato aminotransferasa o alanina aminotransferasa ? 3 x LSN; se permiten valores más altos (es decir, ? 5 x LSN) si son clínicamente compatibles con hematopoyesis extramedular hepática.
    I 09. Esperanza de vida ? 6 meses.
    I 10. Los pacientes con cualquier otra neoplasia maligna previa no son aptos para su inclusión en el estudio, salvo en los siguientes casos: pacientes con carcinoma cutáneo basocelular o espinocelular tratado adecuadamente, cáncer de cuello de útero in situ u otra neoplasia maligna de la que el paciente lleve sin experimentar recidivas durante al menos 5 años.
    I 11. Formulario de consentimiento informado (CI) firmado y formulario de la Ley federal estadounidense de portabilidad y responsabilidad de seguros médicos (Health Insurance Portability and Accountability Act, HIPPA), si procede, para participar en el estudio.
    I 12. Estar dispuesto a cumplir las visitas programadas, los planes de tratamiento, las evaluaciones analíticas y los demás procedimientos relacionados con el estudio.
    E.4Principal exclusion criteria
    Splenectomy.
    Any chemotherapy (eg, hydroxyurea), immunomodulatory drug therapy (eg, thalidomide, interferon-alpha), Anagrelide, immunosuppressive therapy, corticosteroids >10 mg/day prednisone or equivalent, or growth factor treatment (eg, erythropoietin), or hormones (eg, androgens, danazol) within 14 days prior to initiation of IMP or placebo; darbepoetin use within 28 days prior to initiation of IMP or placebo. Patients who have had exposure to hydroxyurea (eg, hydrea) in the past may be enrolled into the study as long as it has not been administered within 14 days prior to initiation of IMP or placebo.
    Major surgery within 28 days or radiation within 6 months prior to initiation of IMP or placebo.
    Prior treatment with a Janus Kinase 2 (JAK2) inhibitor.
    E 01. Esplenectomía.
    E 02. Quimioterapia de cualquier tipo (por ejemplo, hidroxiurea), tratamiento farmacológico inmunomodulador (por ejemplo, talidomida, interferón alfa), anagrelida, tratamiento inmunodepresor, corticosteroides a una dosis > 10 mg/día de prednisona o equivalente, o tratamiento con factores de crecimiento (por ejemplo, eritropoyetina), u hormonas (por ejemplo, andrógenos, danazol), en los 14 días previos al inicio del tratamiento con el PEI o placebo; uso de darbepoetina en los 28 días previos al inicio del tratamiento con el PEI o placebo. Puede incluirse en el estudio a los pacientes que hayan recibido hidroxiurea (por ejemplo, Hydrea) en el pasado, siempre que no se les haya administrado en los 14 días previos al inicio del tratamiento con el PEI o placebo.
    E 03. Cirugía mayor en los 28 días previos al inicio del tratamiento con PEI o placebo o radiación en los 6 meses previos.
    E 04. Tratamiento previo con un inhibidor de JAK2.
    E 05. Tratamiento concomitante con fármacos o plantas medicinales que se sepa que son inhibidores o inductores moderados o potentes del CYP3A4.
    E 06. Tratamiento con ácido acetilsalicílico a dosis > 150 mg.
    E 07. Infección aguda activa que requiera el uso de antibióticos.
    E 08. Insuficiencia cardíaca congestiva no controlada (clase 3 o 4 según la clasificación de la New York Heart Association), angina de pecho, infarto de miocardio, accidente cerebrovascular, cirugía de bypass aortocoronario/aortofemoral, accidente isquémico transitorio o embolia pulmonar en los 3 meses previos al inicio del tratamiento con el PEI o placebo.
    E 09. Participación en un estudio de un producto en fase de investigación (fármaco, agente biológico, dispositivo) en los 30 días previos al inicio del tratamiento con el PEI o placebo, salvo si dicha participación se produce durante una fase que no sea de tratamiento.
    E 10. Mujeres embarazadas o en período de lactancia.
    E 11. Mujeres con capacidad reproductora, excepto si utilizan métodos anticonceptivos eficaces mientras están en tratamiento con el PEI o placebo.
    E 12. Varones que tengan como pareja una mujer con capacidad reproductora, salvo si aceptan utilizar métodos anticonceptivos eficaces durante el tratamiento con el PEI o placebo.
    E 13. Estar infectado por el virus de inmunodeficiencia humana o enfermedad asociada al síndrome de inmunodeficiencia adquirida.
    E 14. Hepatitis B o C clínicamente activa.
    E 15. Cualquier proceso patológico, neurológico o psiquiátrico agudo o crónico grave o datos clínicos anómalos que puedan aumentar el riesgo asociado a la participación en el estudio o a la administración del PEI o placebo, que puedan interferir en el proceso de consentimiento informado y/o en el cumplimiento de los requisitos del estudio, o que puedan interferir en la interpretación de los resultados del estudio y que, en opinión del investigador, harían que el paciente no fuera apto para su inclusión en este estudio.
    E 16. Incapacidad para tragar cápsulas.
    E 17. Presencia de un trastorno significativo digestivo o de otro tipo que inhiba la absorción de los medicamentos orales.
    E.5 End points
    E.5.1Primary end point(s)
    Response Rate (RR), defined as the proportion of patients who have a ?35% reduction in volume of spleen size at the end of Cycle 6, and confirmed 4 weeks thereafter
    Tasa de respuesta (TR), definida como el porcentaje de pacientes con una reducción ? 35 % en el volumen esplénico al final del ciclo 6 y confirmación 4 semanas después.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    6 meses
    E.5.2Secondary end point(s)
    Symptom Response Rate (SRR): Proportion of patients with ?50% reduction from baseline to the end of Cycle 6 in the total symptom score. This assessment will be conducted through the modified MFSAF diary, which will be completed during the week prior to Day 1 of each treatment cycle up to Cycle 6, at end of Cycle 6, the EOT visit, and the 30-day follow-up visit.

    OS (overall survival) of either 400 mg/day or 500 mg/day of IMP as compared to placebo.

    PFS (progression free survival) of either 400 mg/day or 500 mg/day of IMP as compared to placebo.

    Proportion of patients who have ?25% reduction in volume of spleen size at end of Cycle 6, and confirmed 4 weeks thereafter.

    Duration of spleen response, measured by MRI (or CT scan in patients with contraindications for MRI.

    Safety, as assessed by clinical, laboratory, ECG, and vital sign events; graded by the NCI CTCAE v4.03.
    ? Tasa de respuesta de los síntomas (TRS): porcentaje de pacientes con una reducción ? 50 % desde el inicio del estudio hasta el final del ciclo 6 la puntuación total de los síntomas. Esta evaluación se realizará mediante el diario del Formulario modificado MFSAF, que se completará durante la semana previa al día 1 de cada ciclo de tratamiento hasta el ciclo 6, al final del ciclo 6, en la visita de fin del tratamiento y en la visita de seguimiento a los 30 días.
    ? La SG (supervivencia global) con 400 mg/día o 500 mg/día del PEI, en comparación con placebo.
    ? La SSP (supervivencia sin progresión) con 400 mg/día o 500 mg/día del PEI, en comparación con placebo.
    ? Porcentaje de pacientes con una reducción ? 25 % en el volumen esplénico al final del ciclo 6 y confirmación 4 semanas después.
    ? Duración de la respuesta esplénica, medida mediante RMN (o TAC en los pacientes en los que la RMN está contraindicada).
    ? Seguridad, evaluada mediante acontecimientos clínicos y analíticos o relacionados con el ECG y las constantes vitales; clasificados según los CTCAE del NCI, v4.03.
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months to approximately 5 year(s)
    de 6 meses a aproximadamente 5 años
    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 Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    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 No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA57
    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
    Brazil
    Canada
    Israel
    Korea, Republic of
    Mexico
    Russian Federation
    Singapore
    South Africa
    Taiwan
    Turkey
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months7
    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: 112
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 113
    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 state7
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 225
    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)
    Not Applicable
    No aplica
    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 Decision2011-11-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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