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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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:2011-001012-56
    Sponsor's Protocol Code Number:I3X-MC-JHTB
    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:2012-09-03
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-001012-56
    A.3Full title of the trial
    A Phase 2 Study of LY2784544 in Patients with Myeloproliferative Neoplasms
    studio di fase 2 sull'impiego di LY2784544 in pazienti con neoplasie mieloproliferative
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of LY2784544 in Patients with blood cancer
    studio sull’impiego di LY2784544 in pazienti con patologie del sangue (sindromi mieloproliferative)
    A.3.2Name or abbreviated title of the trial where available
    JHTB
    JHTB
    A.4.1Sponsor's protocol code numberI3X-MC-JHTB
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01594723
    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 SponsorELI LILLY AND COMPANY
    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 supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly
    B.5.2Functional name of contact pointClinical trial Information
    B.5.3 Address:
    B.5.3.1Street Addresschemin des coquelicots, 16
    B.5.3.2Town/ cityvernier/ geneva
    B.5.3.3Post code1214
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+441276483153
    B.5.5Fax number+441276483378
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLY2784544
    D.3.2Product code NA
    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 codeLY2784544
    D.3.9.3Other descriptive nameImidazo[1,2-b]pyridazin-6-amine,3-[(4-chloro-2-flurophenyl)methyl]-2-methyl-N-(5-
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 200
    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
    Myeloproliferative neoplasms (MPNs), myelofibrosis, essential
    thrombocythemia, and polycythemia vera
    neoplasie mieloproliferative, mielofibrfosi,trombocitemia essenziale, e policitemia vera
    E.1.1.1Medical condition in easily understood language
    MPNs are a group of diseases of the bone marrow which result in the
    production of excess cells. They are related to and may evolve into
    leukemia.
    neoplasie mieloproliferative sono patologie del midollo osseo che determinano una produzione eccessiva di cellule nel sangue. Queste sono correlate a leucemie.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10036061
    E.1.2Term Polycythemia vera
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level PT
    E.1.2Classification code 10015493
    E.1.2Term Essential thrombocythaemia
    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
    The primary objective of this study is to assess the activity of LY2784544 therapy administered once daily, as measured by objective response rate, in patients with the myeloproliferative neoplasms (MPNs), polycythemia vera (PV), essential thrombocythemia (ET), or myelofibrosis (MF).
    l'obiettivo primario di questo studio è valutare l'attività della terapia con LY2784544 somministrata una volta al giorno, misurata tramite la percentuale di risposta obiettiva, nei pazienti con le seguenti neoplasie mieloproliferative (MPN): Policitemia Vera (PV), Trombocitemia Essenziale (TE) o Mielofibrosi (MF).
    E.2.2Secondary objectives of the trial
    to assess the individual components of response criteria including changes in spleen and liver measurement, changes in JAK2 V617F mutant allele burden, changes in blood counts, changes in bone marrow histology, and changes in transfusion or phlebotomy requirements by MPN subtype
    •to document any change in patient-reported or physician assessment of symptom burden by MPN subtype
    •to estimate the PK parameters of LY2784544 by dose and explore for potential relationship with response for each MPN subtype
    •to document any change in frequency of thrombotic/hemorrhagic events after treatment with LY2784544 by MPN subtype
    •to assess time-to-event measures, including time to best response and duration of response for each MPN subtype•to describe response to LY2784544 in patients with wild-type JAK2
    Caratterizzare il profilo di sicurezza e tossicità di LY2784544 per sottotipo di MPN• Valutare i singoli componenti dei criteri di risposta compresi i cambiamenti delle dimensioni di milza e fegato, i cambiamenti nel carico di alleli mutati JAK2 V617F, le variazioni nella conta ematica, i cambiamenti nell'istologia del midollo osseo e i cambiamenti nella necessità di trasfusioni o flebotomia per sottotipo MPN• Documentare eventuali cambiamenti nella valutazione della sintomatologia riferita dal paziente o valutata dal medico per sottotipo di MPN• Stimare i parametri di farmacocinetica di LY2784544 per dose • Documentare eventuali variazioni nella frequenza di eventi trombotici/emorragici dopo il trattamento con LY2784544 per sottotipo di MPN• Valutare le misure time-to-event, per ogni sottotipo di MPN•Descrivere la risprisposta a LY2784544 nei pazienti con JAK2 wild-type
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must have a diagnosis of PV, ET, or MF as defined by the World Health Organization diagnostic criteria for MPNs. Patients must have discontinued all previous approved therapies for MPNs. Patients must be greater than 18 years of age and both males and females can be enrolled. Patients must have adequate bone marrow reserve: absolute neutrophil count ≥1000/mcL, platelets ≥50,000/mcL for patients with ET or PV, and ≥25,000/mcL for patients with MF.
    i pazienti devono avere una diagnosi di PV, TE o MF come definite dai criteri diagnostici dell'Organizzazione Mondiale della Sanità per le MPN. I pazienti devono aver interrotto tutte le terapie precedenti approvate per la MPN. I pazienti devono avere un'età superiore ai 18 anni e possono essere arruolati sia i maschi sia le femmine. I pazienti devono avere un'adeguata riserva di midollo osseo: conta assoluta dei neutrofili ≥ 1000/mcl, piastrine ≥ 50.000/mcl per i pazienti con TE o PV, e ≥ 25.000/mcl per i pazienti con MF.
    E.4Principal exclusion criteria
    Patients will be excluded if they have a corrected QT (QTc) interval >470 msec, are currently being treated with agents that are metabolized by CYP3A4 or CYP2B6 with a narrow therapeutic margin, are currently being treated with warfarin, have received a hematopoietic stem cell transplant, or have a history of congestive heart failure with New York Heart Association Class >2, unstable angina, recent myocardial infarction or documented history of ventricular arrhythmia.
    I pazienti saranno esclusi se hanno un intervallo QT corretto (QTc) &gt; 470 msec, sono attualmente in trattamento con farmaci metabolizzati da CYP3A4 o CYP2B6 con un margine terapeutico limitato, sono attualmente in trattamento con warfarina, hanno ricevuto trapianto di cellule staminali ematopoietiche, o hanno un’anamnesi di insufficienza cardiaca congestizia con Classe della New York Heart Association &gt; 2, angina instabile, recente infarto del miocardio o aritmia ventricolare documentata.
    E.5 End points
    E.5.1Primary end point(s)
    This study is designed to assess evidence of efficacy of LY2784544 and
    at least 1 out of 10 patients in each cohort must demonstrate objective
    response in order for the regimen to be considered for further study.
    nello studio saranno arruolati circa 125 pazienti con MPN, suddivisi in coorti sulla base del sottotipo di MPN. Il disegno dello studio è volto a valutare l'evidenza dell'efficacia di LY2784544, e almeno un paziente su 10 in ogni coorte deve esibire una risposta obiettiva affinché il regime possa essere considerato per ulteriori studi.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Bone Marrow Core Biopsy and Aspirate with karyotype evaluation, as
    well as physician assessment of response will be done in Cycle 6 and
    every 6th cycle thereafter (i.e., Cycle 12, 18, 24, etc) or if evidence of
    molecular remission.
    CT or MRI of Spleen and Liver (may include contrast), as well as
    physician assessment of response will be collected only in Cycles 3, 6, 9,
    12 and then every 6th cycle.
    La Biopsia del midollo osseo e L aspirato per la valutazione del cariotipo,così come valutazione mediche della risposta saranno effettuate al ciclo 6 ed ogni 6 cicli o in presenza di remissione cellulare.
    E.5.2Secondary end point(s)
    Response rate, molecular response rate, hematological improvement rate, splenomegaly response rate, bone marrow biopsy histology improvement rate, thrombotic or hemorrhagic event rate, coagulation factor status, frequency of phlebotomies and transfusions, duration of response, time to best response, International Prognostic Scoring System, Dynamic International Prognostic Scoring System (DIPSS), DIPSS Plus, and time to treatment failure
    percentuale di risposta, percentuale di risposta molecolare, percentuale di miglioramento ematologico, percentuale di risposta della splenomegalia, percentuale di miglioramento istologico verificato tramite biopsia del midollo osseo, percentuale di eventi trombotici o emorragici, stato del fattore di coagulazione, frequenza di flebotomie e trasfusioni, durata della risposta, tempo alla risposta migliore, International Prognostic Scoring System, Dynamic International Prognostic Scoring System (DIPSS), DIPSS Plus e tempo al fallimento del trattamento
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints will be evaluated throughout the study according to
    timepoints in the study schedule of events.
    gli endpouints secondari saranno valutati durante lo studio secondo le tempistiche del protocollo riportate nella schedula degli eventi.
    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 No
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    European Union
    Australia
    Canada
    United States
    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
    LVLS
    LVLS
    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 months33
    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 months33
    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: 138
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 118
    F.4.2.2In the whole clinical trial 188
    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)
    Patients will receive study treatment until they require discontinuation of study therapy.
    After that pats will be treated according local medical practice and will continue to receive a follow up according protocol follow up procedures
    i pazienti riceveranno il trattamentod is tudio fino a disocntinuazione. dopodichè continueranno ad essere seguiti secondo la normale pratica clinica e continueranno a ricevere follow up come indicato nel protocollo.
    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 Decision2012-08-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-16
    P. End of Trial
    P.End of Trial StatusCompleted
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