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    Summary
    EudraCT Number:2011-001897-25
    Sponsor's Protocol Code Number:EFC12153-JAKARTA
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-12-27
    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 ConcernedItaly - Italian Medicines Agency
    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
    Studio di fase III, multicentrico, randomizzato, in doppio cieco, a 3 bracci, controllato con placebo, con SAR302503 somministrato in pazienti con splenomegalia affetti da mielofibrosi primaria o da mielofibrosi post-policitemia vera o da mielofibrosi post-trombocitemia essenziale, di grado 2-intermedio o ad alto rischio.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 3 Study of SAR302503 in patients with Myelofibrosis
    Studio di Fase III in pazienti con mielofibrosi
    A.4.1Sponsor's protocol code numberEFC12153-JAKARTA
    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 ET 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 & de'veloppement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi-Aventis Spa
    B.5.2Functional name of contact pointcontact point
    B.5.3 Address:
    B.5.3.1Street Addressviale L. Bodio 37/B
    B.5.3.2Town/ cityMILANO
    B.5.3.3Post code20158
    B.5.3.4CountryItaly
    B.5.4Telephone number800.226343
    B.5.5Fax number0039 02.3939.4168
    B.5.6E-mailinformazioni.medicoscientifiche@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.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 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
    mielofibrosi primaria o mielofibrosi post-policitemia vera o da mielofibrosi post-trombocitemia essenziale
    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
    malattia del sangue nella quale il midollo osseo produce troppi globuli rossi o troppe piastrine
    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 14.1
    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).
    •Dimostrare l’efficacia di SAR302503 (farmaco sperimentale) somministrato una volta al giorno per via orale alle dosi di 400 o 500 mg in confronto a placebo nel ridurre il volume della milza misurato mediante risonanza magnetica (o TAC in caso i pazienti abbiano controindicazioni alla risonanza magnetica).
    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
    •Misurare gli effetti sui sintomi associati alla mielofibrosi (sintomi chiave della mielofibrosi), utilizzando il diario “Myelofibrosis Symptom Assessment Form (MF-SAF)”.
    •Valutare la sopravvivenza globale dei pazienti trattati con farmaco sperimentale alle dosi di 400 mg o 500 mg al giorno in confronto a placebo.
    •Valutare la sopravvivenza libera da progressione dei pazienti trattati con il farmaco sperimentale alle dosi di 400 mg o 500 mg al giorno in confronto a placebo.
    •Valutare la durata della risposta della milza.
    •Valutare il profilo di tollerabilità del farmaco sperimentale
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PHARMACOGENETIC:
    Vers:1
    Date:2011/07/26
    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
    Objectives:pharmacogenetics explores the effect of genes on the variability of drug responses and/or drug metabolism among people taking the same medicine

    FARMACOGENETICA:
    Vers:1
    Data:2011/07/26
    Titolo:bla
    Obiettivi:bla

    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. Diagnosi di mielofibrosi primaria, o di mielofibrosi post-policitemia vera o di mielofibrosi post-trombocitemia essenziale in accordo ai criteri del 2008 della World Health Organization e ai criteri IWG-MRT.
    I 02. Mielofibrosi di grado 2-intermedio o ad alto rischio come definito dai criteri modificati IWG-MRT.
    I 03. Milza ingrossata, palpabile per almeno 5 cm al di sotto del margine costale.
    I 04. Almeno 18 anni di età.
    I 05. ECOG, performance status pari a 0, 1, o 2 all’ingresso nello studio.
    I 06. I seguenti valori di laboratorio entro 14 giorni prima dell'inizio del farmaco sperimentale o del placebo:
    • conta assoluta dei neutrofili (ANC) ≥1,0  109/l
    • conta delle piastrine ≥ 50  109/l
    • creatinina sierica ≤1,5 volte il limite superiore di normalità (ULN).
    • amilasi sierica o lipasi ≤1,5 volte il limite superiore di normalità (ULN).
    I 07. Bilirubina diretta ≤2 volte il limite superiore di normalità (ULN).
    I 08. Alanina aminotransferasi (ALT) e aspartato aminotransferasi (AST) ≤ 3 volte il limite superiore di normalità; valori più alti (≤ 5 volte il limite superiore di normalità) sono permessi se clinicamente compatibili con ematopoiesi epatica extramidollare.
    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. Splenectomia.
    E 02. Pazienti sottoposti a terapia entro 14 giorni prima dell’inizio del farmaco sperimentale o del placebo con qualsiasi chemioterapico (ad esempio, idrossiurea), con qualsiasi terapia farmacologica immunomodulatoria (ad esempio, talidomide, interferone alfa), anagrelide, terapia immunosoppressiva, con corticosteroidi prednisone o equivalente assunti ad un dosaggio superiore a 10 mg al giorno, o terapia con fattori di crescita (ad esempio, eritropoietina), o ormoni (ad esempio, androgeni, danazolo); darbepoetina utilizzata nei 28 giorni precedenti l’inizio del farmaco sperimentale o del placebo. I pazienti che sono stati esposti all’idrossiurea (ad esempio, Hydrea) in passato possono essere arruolati nello studio se non è stata somministrata nei 14 giorni precedenti l’inizio del farmaco sperimentale o del placebo.
    E 03. Pazienti sottoposti a intervento chirurgico importante nei 28 giorni precedenti l’inizio del trattamento in studio o a radioterapia nei 6 mesi precedenti l’inizio del farmaco sperimentale o del placebo.
    E 04. Trattamenti precedenti con altri inibitori JAK2.
    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
    •Tasso di risposta (RR), definita come la percentuale di pazienti che hanno una riduzione del volume della milza ≥ 35% alla fine del ciclo 6, confermata 4 settimane dopo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    6 mesi
    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.
    • Tasso di risposta dei sintomi (SRR): percentuale di pazienti con una riduzione ≥ 50% del punteggio totale dei sintomi alla fine del ciclo 6 rispetto al basale. Questa valutazione sarà effettuata attraverso il diario MF-SAF, che sarà completato durante la settimana prima del giorno 1 di ciascun ciclo di trattamento fino al ciclo 6, alla fine del ciclo 6, alla visita di fine trattamento e alla visita di follow-up a 30 giorni.
    • Sopravvivenza globale (OS) sia con la dose di 400 mg al giorno, sia con la dose di 500 mg al giorno di farmaco sperimentale in confronto a placebo.
    • Sopravvivenza libera da progressione (PFS) sia con la dose di 400 mg al giorno, sia con la dose di 500 mg al giorno di farmaco sperimentale in confronto a placebo.
    • Percentuale di pazienti che hanno una riduzione del volume della milza ≥ 25% alla fine del ciclo 6, confermata 4 settimane dopo.
    • Durata della risposta della milza, misurata tramite risonanza magnetica (o tramite TAC in pazienti con controindicazioni ad eseguire la risonanza magnetica).
    • Tollerabilità, valutata mediante i parametri clinici, di laboratorio, gli ECG e i segni vitali, il cui grado sarà valutato in base ai criteri NCI CTCAE 4.03.
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months to approximately 5 year(s)
    da 6 mesi a circa 5 anni
    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 No
    E.6.10Pharmacogenetic No
    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 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 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, Democratic People's 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
    LPLS
    LPLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months55
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months55
    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.1.1Number of subjects for this age range: 0
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    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)
    none
    nessuno
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-08-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-08-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-07-04
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