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    EudraCT Number:2018-001334-18
    Sponsor's Protocol Code Number:CarPAs
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-10-07
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-001334-18
    A.3Full title of the trial
    Cardiovascular assessment of Ponatinib as treatment option in chronic phase chronic myeloid leukemia after failure of Imatinib and Bosutinib (CarPAs)
    Valutazione cardiovascolare di Ponatinib come opzione di trattamento in pazienti affetti da leucemia mieloide cronica in fase cronica dopo il fallimento della terapia con Imatinib e Bosutinib (CarPAs)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the therapeutic activity and of the cardiovascular safety profile of Ponatinib when used as treatment option of Chronic Myeloid Leukemia (CML) in Chronic Phase (CP), after failure of therapy with Imatinib and Bosutinib.
    Valutazione dell'attività terapeutica e del profilo di sicurezza a livello cardiovascolare di Ponatinib in pazienti affetti da leucemia mieloide cronica in fase cronica dopo il fallimento del trattamento con Imatinib e Bosutinib
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberCarPAs
    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 SponsorAssociazione Italiana Pazienti Leucemia Mieloide Cronica (AIPLMC)
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportIncyte Biosciences International Sàrl
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGalSeq srl
    B.5.2Functional name of contact pointGestione studi clinici
    B.5.3 Address:
    B.5.3.1Street AddressVia Ludovico Ariosto, 21
    B.5.3.2Town/ cityBresso
    B.5.3.3Post code20091
    B.5.4Telephone number0283427930
    B.5.5Fax number0283427931
    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 Yes
    D. of the Marketing Authorisation holderINCYTE BIOSCIENCES DISTRIBUTION B.V.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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/3/09/716
    D.3 Description of the IMP
    D.3.1Product nameICLUSIG 15 MG
    D.3.2Product code [AP24534]
    D.3.4Pharmaceutical form Film-coated 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 INNPONATINIB
    D.3.9.1CAS number 943319-70-8
    D.3.9.2Current sponsor codeAP24534
    D.3.9.4EV Substance CodePRD4872105
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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. cell therapy medicinal product Information not present in EudraCT
    D. therapy medical product Information not present in EudraCT
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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 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
    Chronic Myeloid Leukemia (CML) in Chronic Phase (CP)
    Leucemia Mieloide Cronica (LMC) in Fase Cronica
    E.1.1.1Medical condition in easily understood language
    Chronic Phase Chronic Myeloid Leukemia patients, who have been treated first-line with imatinib and then switched to bosutinib (or viceversa) for failure or intolerance
    Pazienti affetti da leucemia mieloide cronica in fase cronica, precedentemente trattati con Imatinib e Bosutinib e che hanno mostrato intolleranza e/o resistenza ai farmaci
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10009013
    E.1.2Term Chronic myeloid leukaemia
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10009013
    E.1.2Term Chronic myeloid leukaemia
    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 assess Ponatinib safety cardiovascular profile at 1 year after the study treatment initiation of each patient
    Valutare il profilo di sicurezza cardiovascolare di Ponatinib a 1 anno dopo l'inizio del trattamento in studio di ciascun paziente
    E.2.2Secondary objectives of the trial
    1. To assess the ponatinib safety profile at 2 and 3 years after the study treatment initiation.
    2. To assess ponatinib venous occlusive safety profile at 1, 2 and 3 years after the study treatment initiation.
    3. To assess the achievement of Complete Cytogenetic Response (CCyR) and/or BCR-ABL level <1% in resistant patients at 1, 2 and 3 years after the study treatment initiation.
    4. To assess the achievement of Molecular responses (MMR [BCR-ABL level <0.1%] or better) at 1, 2 and 3 years after the study treatment initiation.
    5. To assess the maintenance of response at 1, 2 and 3 years after the study treatment initiation in intolerant patients.
    6. To assess the Overall Survival (OS), the Progression Free Survival (PFS) at 1, 2 and 3 years after the study treatment initiation in intolerant patients.
    1. Valutare il profilo di sicurezza di ponatinib a 2 e 3 anni dopo l'inizio del trattamento dello studio.
    2. Valutare il profilo di sicurezza venosa occlusiva di ponatinib a 1, 2 e 3 anni dopo l'inizio del trattamento dello studio.
    3. Valutare il raggiungimento del livello di risposta citogenetica completa (CCyR) e / o BCR-ABL <1% nei pazienti resistenti a 1, 2 e 3 anni dopo l'inizio del trattamento dello studio.
    4. Valutare il raggiungimento delle risposte molecolari (MMR [livello BCR-ABL <0,1%] o migliore) a 1, 2 e 3 anni dopo l'inizio del trattamento dello studio.
    5. Valutare il mantenimento della risposta a 1, 2 e 3 anni dopo l'inizio del trattamento dello studio nei pazienti intolleranti.
    6. Valutare la sopravvivenza globale (OS), la sopravvivenza libera da progressione (PFS) a 1, 2 e 3 anni dopo l'inizio del trattamento dello studio nei pazienti intolleranti.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Signed and dated Informed Consent approved by Local Ethical Committee before any protocol-specific screening procedures.
    2) CML diagnosis, Chronic Phase (CP), treated with imatinib and bosutinib or bosutinib only. Previous treatment with dasatinib or nilotinib will not be allowed.
    3) Resistant or intolerant to imatinib and/or bosutinib.
    4) Able to take oral therapy.
    5) Female or male, 18 years of age or older.
    6) ECOG performance status 0-2.
    7) Minimum life expectancy of 3 months or more.
    8) Adequate organ function as defined by the following criteria:
    - Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) = 2.5 x upper limit of normal (ULN) or AST and ALT = 5 x ULN if liver function abnormalities are due to underlying malignancy
    - Total serum bilirubin = 1.5 x ULN (except patients with documented Gilbert’s syndrome)
    - Creatinine = 1.5 x ULN
    - Prothrombin time (PT) < 1.5 × ULN
    - Lipase = 1.5 × ULN for institution
    - Amylase = 1.5 × ULN for institution
    9) Normal QTcF interval on screening electrocardiogram (ECG) evaluation, defined as QTcF of = 450 ms in males or = 470 ms in females.
    10) Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
    11) Female and male patients who are of childbearing potential must agree to use a highly effective method of contraception with a failure rate of less than 1% per year (2 forms of contraception, hormonal and barrier) with their partners throughout participation in this study and for at least 90 days after the last dose of treatment.
    12) For females of childbearing potential, a negative pregnancy test must be documented prior to enrolment.
    1) Consenso informato firmato e datato approvato dal comitato etico locale prima di qualsiasi procedura di screening specifica del protocollo.
    2) Diagnosi di LMC, Fase cronica (CP), trattata con imatinib e bosutinib o con solo bosutinib. Non sarà consentito il trattamento precedente con dasatinib o nilotinib.
    3) Resistente o intollerante a imatinib e/o bosutinib.
    4) In grado di prendere terapia orale.
    5) Femmina o maschio, di età uguale o superiore ai 18 anni.
    6) ECOG 0-2.
    7) Aspettativa di vita minima di 3 mesi o più.
    8) Funzione di organo adeguata come definita dai seguenti criteri:
    - Siero aspartato transaminasi (AST) e siero alanina transaminasi (ALT) = 2,5 x limite superiore della norma (ULN) o AST e ALT = 5 x ULN se anomalie della funzione epatica sono dovute a neoplasie sottostanti
    - Bilirubina sierica totale = 1,5 x ULN (eccetto i pazienti con sindrome di Gilbert documentata)
    - Creatinina = 1,5 x ULN
    - Tempo di protrombina (PT) <1,5 × ULN
    - Lipasi = 1,5 × ULN per istituzione
    - Amilasi = 1,5 × ULN per istituzione
    9) Intervallo QTcF normale alla valutazione dell'elettrocardiogramma di screening (ECG), definito come QTcF di = 450 ms nei maschi o = 470 ms nelle donne.
    10) Disponibilità e capacità di rispettare visite programmate, piani di trattamento, test di laboratorio e altre procedure di studio.
    11) I pazienti di sesso femminile e di sesso maschile che sono potenzialmente fertili devono accettare di utilizzare un metodo contraccettivo altamente efficace con un tasso di fallimento inferiore all'1% all'anno (2 forme di contraccezione, ormonale e di barriera) con i loro partner per tutta la partecipazione a questo studio e per almeno 90 giorni dopo l'ultima dose di trattamento.
    12) Per le donne in età fertile, un test di gravidanza negativo deve essere documentato prima dell'arruolamento.
    E.4Principal exclusion criteria
    1) Current treatment on another therapeutic clinical trial.
    2) Received TKI therapy within 7 days prior to receiving the first dose of ponatinib, or have not recovered (> grade 1 by NCI CTCAE, v. 4.0) from AEs (except alopecia) due to agents previously administered.
    3) Underwent autologous or allogeneic stem cell transplant < 60 days prior to receiving the first dose of ponatinib; any evidence of on-going graft versus-host disease (GVHD), or GVHD requiring immunosuppressive therapy.
    4) Take medications that are known to be associated with Torsades de Pointes.
    5) Require concurrent treatment with immunosuppressive agents, other than corticosteroids prescribed for a short course of therapy.
    6) Have previously been treated with ponatinib.
    7) Have active central nervous system (CNS) disease as evidenced by cytology or pathology. In the absence of clinical CNS disease, lumbar puncture is not required. History itself of CNS involvement is not exclusionary if CNS has been cleared with a documented negative lumbar puncture.
    8) Have significant or active cardiovascular disease, specifically including, but not restricted to:
    a. Myocardial infarction within 3 months prior to first dose of ponatinib,
    b. History of clinically significant atrial arrhythmia or any ventricular arrhythmia,
    c. Unstable angina within 3 months prior to first dose of ponatinib,
    d. Congestive heart failure within 3 months prior to first dose of ponatinib.
    9) Have a significant bleeding disorder unrelated to CML or Ph+ ALL.
    10) Have a history of pancreatitis or alcohol abuse.
    11) Have uncontrolled hypertriglyceridemia (triglycerides > 450 mg/dL).
    12) Have malabsorption syndrome or other gastrointestinal illness that could affect absorption of orally administered ponatinib.
    13) Have been diagnosed with another primary malignancy within the past 3 years (except for non-melanoma skin cancer or cervical cancer in situ, or controlled prostate cancer, which are allowed within 3 years).
    14) Pregnancy or breastfeeding
    15) Underwent major surgery (with the exception of minor surgical procedures, such as catheter placement or BM biopsy) within 14 days prior to first dose of ponatinib
    16) Have ongoing or active infection (including known history of human immunodeficiency virus [HIV] or hepatitis C virus [HCV]). Testing for these viruses is not required in the absence of history
    17) Be positive for blood serum for Hepatitis B serology (Hepatitis B surface Antigen, Hepatitis B core Antibody, and Hepatitis B surface Antibody) at the time of screening
    18) Other severe acute or chronic medical or psychiatric conditions, or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration
    19) Known hypersensitivity to one of IMP’s excipients, which is lactose monohydrate (rare hereditary galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption)
    1) Trattamento corrente in un'altra sperimentazione clinica terapeutica.
    2) Terapia TKI ricevuta entro 7 giorni prima di ricevere la prima dose di ponatinib, o non aver recuperato (> grado 1 da NCI CTCAE, v. 4.0) da AEs (eccetto l'alopecia) a causa di agenti precedentemente somministrati.
    3) Sottoposto a trapianto di cellule staminali autologhe o allogeniche <60 giorni prima di ricevere la prima dose di ponatinib; qualsiasi evidenza di malattia del trapianto-ospite in corso (GVHD), o GVHD che richiede terapia immunosoppressiva.
    4) Prendere farmaci che sono noti per essere associati con Torsades de Pointes.
    5) Richiedere un trattamento concomitante con agenti immunosoppressori, diversi dai corticosteroidi prescritti per un breve ciclo di terapia.
    6) Essere stato precedentemente trattato con ponatinib.
    7) Avere una malattia attiva del sistema nervoso centrale (SNC) come evidenziato da citologia o patologia. In assenza di malattia clinica del SNC, non è richiesta la puntura lombare. La storia stessa del coinvolgimento del SNC non è escludente se il CNS è stato eliminato con una puntura lombare negativa documentata.
    8) Avere una malattia cardiovascolare significativa o attiva, in particolare incluso, ma non limitato a:
    a. Infarto miocardico entro 3 mesi prima della prima dose di ponatinib,
    b. Storia di aritmia atriale clinicamente significativa o qualsiasi aritmia ventricolare,
    c. Angina instabile entro 3 mesi prima della prima dose di ponatinib,
    d. Insufficienza cardiaca congestizia nei 3 mesi precedenti la prima dose di ponatinib.
    9) Avere un disturbo emorragico significativo non correlato alla LMC o al LLA Ph +.
    10) Ha una storia di pancreatite o abuso di alcool.
    11) Avere ipertrigliceridemia incontrollata (trigliceridi> 450 mg / dl).
    12) Avere la sindrome da malassorbimento o altre malattie gastrointestinali che potrebbero influenzare l'assorbimento di ponatinib somministrato per via orale.
    13) Essere stato diagnosticato con un altro tumore maligno primario negli ultimi 3 anni (ad eccezione del tumore della pelle non melanoma o del cancro cervicale in situ o del carcinoma prostatico controllato, che sono consentiti entro 3 anni).
    14) Gravidanza o allattamento.
    15) Aver subito un intervento chirurgico maggiore (ad eccezione delle procedure chirurgiche minori, come il posizionamento del catetere o la biopsia della BM) entro 14 giorni prima della prima dose di ponatinib.
    16) Avere un'infezione continua o attiva (inclusa storia nota di virus dell'immunodeficienza umana [HIV] o virus dell'epatite C [HCV]). Il test per questi virus non è richiesto in assenza di cronologia.
    17) Essere positivi per il siero del sangue per la sierologia dell'epatite B (antigene di superficie dell'epatite B, anticorpo del nucleo di epatite B e anticorpo di superficie dell'epatite B) al momento dello screening.
    18) Altre gravi condizioni mediche o psichiatriche acute o croniche, o anormalità di laboratorio che impartirebbero, a giudizio dello sperimentatore e / o dello sponsor, un eccesso di rischio associato alla partecipazione allo studio o alla somministrazione del farmaco in studio.
    19) Ipersensibilità nota a uno degli eccipienti dell’IMP, che è il lattosio monoidrato (rara intolleranza ereditaria al galattosio, deficit di Lapp lattasi o malassorbimento di glucosio-galattosio)
    E.5 End points
    E.5.1Primary end point(s)
    Exposure adjusted Rate of Arterial Occlusive Events (AOE) and Serious AOE (SOE) at 1 year after study treatment initiation of each patient
    Tasso aggiustato di esposizione di eventi occlusivi arteriosi (AOE) e di AOE grave (SOE) a 1 anno dopo l'inizio del trattamento dello studio di ciascun paziente
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 year
    1 anno
    E.5.2Secondary end point(s)
    Exposure adjusted Rate of Venous Occlusive Events at 1, 2 and 3 years
    Exposure adjusted Rate of AOE and serious AOE at 2 and 3 years after the study treatment initiation; Tasso di esposizione dell'AOE corretto e AOE grave a 2 e 3 anni dopo l'inizio del trattamento dello studio; Tasso di esposizione degli eventi occlusivi venosi a 1, 2 e 3 anni
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 and 3 years; 1, 2 and 3 years
    2 e 3 anni; 1, 2 e 3 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 No
    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. 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 No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned13
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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: 50
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 50
    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)
    At the end of their participation in the study, patients will be contacted for the safety with a follow-up 30 days after their last dose of ponatinib.
    Al termine della loro partecipazione allo studio, i pazienti verranno poi contattati per la sicurezza con un follow-up a 30 giorni dall'ultima dose di ponatinib.
    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 Decision2019-11-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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