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    Summary
    EudraCT Number:2005-002258-23
    Sponsor's Protocol Code Number:C0701a/204/ON/US
    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:2005-11-04
    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 number2005-002258-23
    A.3Full title of the trial
    A Randomized, Open-Label Study of Oral CEP-701 Administered in Sequence With Standard Chemotherapy to Patients With Relapsed Acute Myeloid Leukemia (AML) Expressing FLT-3 Activating Mutations
    Studio randomizzato, in aperto con CEP-701 per via orale, somministrato dopo la Chemioterapia Standard in pazienti affetti da Leucemia Mieloide Acuta (AML) recidivante con manifestazioni di mutazioni da attivazione di FLT-3
    A.4.1Sponsor's protocol code numberC0701a/204/ON/US
    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 SponsorCEPHALON EUROPE
    B.1.3.4CountryUnited Kingdom
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameLESTAURTINIB
    D.3.2Product code CEP-701
    D.3.4Pharmaceutical form Oral solution
    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 INNLESTAURTINIB
    D.3.9.1CAS number 111358-88-4
    D.3.9.2Current sponsor codeCEP-701
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number80
    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
    Acute Myeloid Leukemia
    Leucemia Mieloide Acuta
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10059034
    E.1.2Term Acute myeloid leukaemia recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to determine whether CEP 701 given in sequence with induction chemotherapy increases the proportion of patients with relapsed AML who achieve a second CR/CRp.
    L'obiettivo principale e` determinare se CEP-701 somministrato dopo chemioterapia di induzione aumenta la proporzione di pazienti affetti da leucemia mieloide acuta recidivante (AML) che raggiungono un secondo recupero completo (RC) alla valutazione del risultato.
    E.2.2Secondary objectives of the trial
    •Overall Survival •Event-free Survival •Remission duration for patients who achieve a CR/CRp •Proportion of patients who achieve an outcome of PR •Proportion of patients who maintain an outcome of CR/CRp up to day 113 •Proportion of patients who achieve an outcome of CR/CRp after crossing over to treatment with CEP-701 •Safety and tolerability of CEP-701 •PK of CEP-701 •CEP-701 inhibitory activity in plasma by means of a FLT-3 ex-vivo bioassay
    •la proporzione di pazienti che raggiunge un RC con un recupero del quadro ematico incompleto (RCi) •la proporzione di pazienti che raggiunge un recupero parziale (RP) •la proporzione di pazienti che mantiene un risultato di RC fino al giorno 113 •la proporzione di pazienti che passa a trattamento CEP-701 sequenziale che raggiunge un risultato di RC al giorno 113 •durata del recupero (per pazienti che raggiungono un PR) •sopravvivenza senza eventi •sopravvivenza generale •sicurezza e tollerabilita` del CEP-701 somministrato dopo chemioterapia durante tutto lo studio •farmacocinetica del CEP-701 in momenti specifici •Attivita` inibitorie del CEP-701 nel plasma tramite test biologico e test cellulare ex-vivo per FLT-3 (fms-like tyrosine kinase 3) eseguiti in momenti specifici.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Cytological confirmation of AML •Relapsed disease following first CR of duration 1 - 24 months Time from first relapse to study entry £ 30 days •Confirmation of FLT 3 positive status after point of initial relapse •Aged ³ 18 years and older •Written informed consent •Ability to understand and comply with study restrictions •No co-morbid conditions that would limit life expectancy to <3 months •ECOG 0 - 2 •Pregnancy precautions as appropriate
    •conferma citologica di leucemia mieloide acuta (AML) •malattia recidivante dopo un primo recupero completo (RC) della durata che va da 1 mese (30 giorni) fino a 24 mesi (730 giorni). Il periodo di tempo dalla prima ricaduta all'ingresso allo studio (inizio del primo corso di chemioterapia di induzione) non deve essere superiore a 30 giorni •conferma di positivita` di mutazioni associate all'attivazione di FLT3 dopo il punto di ricaduta iniziale •eta` uguale o superiore ai 18 anni •consenso informato scritto •capacita` di intendere e attenersi alle restrizioni previste dallo studio •nessuna condizione patologica che possa limitare il periodo di aspettativa di vita a meno di 3 mesi •grado di Eastern Cooperative Oncology Group (ECOG) pari a 0, 1 o 2 •le donne non devono essere in stato interessante o in fase di allattamento, non devono essere in grado di procreare oppure devono utilizzare un contraccettivo adeguato ed avere eseguito un test di gravidanza con esito negativo al momento d'ingresso alla ricerca
    E.4Principal exclusion criteria
    •Bilirubin >2 times ULN, ALT or AST >3 times ULN •Serum creatinine >1.5 mg/dL •Resting ejection fraction <45% (MEC patients only) •Untreated or progressive infection •Physical or psychiatric condition that may compromise participation •Known central nervous system involvement with AML •Any prior treatment with a FLT 3 inhibitor •Requirement for HIV protease inhibitors •Active gastrointestinal ulceration or bleeding •Use an investigational drug that is not expected to be cleared by the start of CEP-701
    •livelli di bilirubina 2 volte oltre il limite superiore della norma (ULN), livelli di transaminasi alanina o transaminasi aspartica superiore a tre volte il limite superiore della norma •concentrazioni di creatinina nel siero piu` alte di 1,5 mg/Dl •frazione di eiezione inattiva del ventricolo sinistro inferiore al 45% (solo a pazienti prescelti a ricevere mitoxantrone, etoposide e citarabina [MEC]) •infezione non trattata o progressiva •stato di salute fisico o psichico che possa compromettere la partecipazione allo studio •coinvolgimento conosciuto del sistema nervoso centrale con AML •trattamenti precedenti con inibitore FLT-3 •paziente che necessita di trattamento per virus dell'immunodeficienza umana (HIV) con inibitori della proteasi •ulcera o emorragia gastrointestinale attiva •utilizzo di un farmaco sperimentale entro i 30 giorni dalla visita di base
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of patients who achieve an outcome of complete remission at the outcome assessment (CR/CRp).
    La proporzione di pazienti che raggiungono un recupero completo(RC) alla valutazione del risultato.
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    terapia standard
    E.8.2.4Number of treatment arms in the trial2
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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 No
    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
    Ultima visita dell`ultimo paziente alla fine del periodo di follow up
    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 months29
    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.1.1Number 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.1.3Elderly (>=65 years) Yes
    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 Yes
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 220
    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 Decision2005-07-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-07-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2009-12-18
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