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    Summary
    EudraCT Number:2004-004527-35
    Sponsor's Protocol Code Number:BIOV-121
    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:2005-07-20
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2004-004527-35
    A.3Full title of the trial
    A Phase II Trial of Clofarabine in Older Patients with Acute Myeloid Leukaemia for Whom Intensive Chemotherapy is Not Considered Suitable
    A Phase II Trial of Clofarabine in Older Patients with Acute Myeloid Leukaemia for Whom Intensive Chemotherapy is Not Considered Suitable
    A.4.1Sponsor's protocol code numberBIOV-121
    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 SponsorBioenvision Limited
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/03/141
    D.3 Description of the IMP
    D.3.1Product nameclofarabine
    D.3.2Product code NA
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNclofarabine
    D.3.9.1CAS number 123318-82-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number20
    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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    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 10000880
    E.1.2Term Acute 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 determine the overall response (OR) rate with clofarabine in older patients with untreated AML, for whom intensive chemotherapy is not considered suitable. The OR rate is defined as the sum of the number of patients in the study population with complete remission (CR); complete remission with incomplete blood count recovery (CRi); and partial remission (PR) divided by the total number of patients in the study population.
    Determinare la percentuale di risposta complessiva (OR, overall response, definito quale la somma del numero di pazienti nella popolazione in studio con remissione completa (CR), remissione completa con recupero incompleto della conta delle cellule ematiche (CRi), e remissione parziale (PR), divisa per il numero totale di pazienti nella popolazione in studio.
    E.2.2Secondary objectives of the trial
    To document in the study population: the rate of CR(s) CRi(s)and PR(s); time to event parameters including duration of complete remission and overall survival (OS) and time to complete remission for each patient up to 24 months after last dose of clofarabine; safety profile and tolerability of clofarabine for this population and dosing regimen; the pharmacokinetic profile and intracellular triphosphate levels of clofarabine in the study population.
    Documentare nella popolazione in studio: il tasso di CR,CRi e PR; il tempo all`evento di parametri comprendenti (a) durata di remissione,(b) sopravvivenza complessiva (OS,overall survival) e (c) tempo alla remissione per ogni paziente fino a 24 mesi dall`ultima dose di clofarabina; il profilo di sicurezza e tollerabilita` della clofarabina; il profilo di farmacocinetica e i tassi intracellulari di trifosfato della clofarabina.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PHARMACOKINETIC/PHARMACODYNAMIC:
    Vers:
    Date:
    Title:
    Objectives:
    FARMACOCINETICA/FARMACODINAMICA:
    Vers:
    Data:
    Titolo:
    Obiettivi:
    E.3Principal inclusion criteria
    1. Patients must have untreated AML as defined by the WHO classification 2. Patients must provide written informed consent. 3. Male or Post-Menopausal female patients &#8805; 65 years of age and unsuitable for intensive chemotherapy. 4. Male patients who are fertile agree to use an effective barrier method of birth control to avoid pregnancy. 5. Patients must be able to comply with study procedures and follow-up examinations. 6. Patients must have adequate organ function as indicated by the following laboratory values, obtained within 7 days prior to enrolment. Serum Bilirubin < 1.5 x ULN AST and ALT < 2 x ULN Creatinine < 1.5 x ULN Prothrombin Time < 1.5 x control ULN = Institutional Upper Limit of Normal.
    1. I pazienti devono presentare AML non trattata come definito dall aWHO classification 2. I pazienti devono fornire consenso informato scritto 3. Uomini o donne post menopausa &#8805; 65 anni per cui la chemioterapia intensiva e` controindicata 4. Uomini fertili che accettano di utilizzare metodo barriera efficace per evitare gravidanze 5. Pazienti in grado di effettuare le procedure dello studio e gli esami di follow up. 6. Pazienti che possiedono una funzionalita` dei vari organi indicata dai seguenti valori di laboratorio ottenuti 7 giorni prima dell'arruolamento. Bilirubina serica &lt; 1.5 x ULN AST e ALT &lt; 2 x ULN Creatinina &lt; 1.5 x ULN Tempo di Protrombina &lt; 1.5 x controllo ULN = Range di normalita` superiore del centro
    E.4Principal exclusion criteria
    1. Patients who have an active, uncontrolled systemic infection considered opportunistic, life threatening or clinically significant at the time of treatment. 2. Patients who have a psychiatric disorder(s) that would interfere with consent, study participation or follow-up. 3. Patients who are receiving other chemotherapy or corticosteroids (unless the latter is administered at a low dose for pre-medication purposes or for the treatment of chronic conditions - e.g., rheumatoid arthritis). 4. Patients who have received prior treatment for leukaemia. Patients who have received growth factor, cytokine support, leukopheresis or, hydroxyurea, will be allowed into the study but must discontinue treatment at least 24 hours prior to beginning treatment with clofarabine. 5. Patients who have any other severe concurrent disease (severe Coronary Artery Disease (CAD), significant neurological disorder, uncontrolled diabetes, etc), which, in the judgment of the investigator, would make the patient inappropriate for entry into this study. 6. Patients who have symptomatic Central Nervous System (CNS) involvement. 7. Patients who have previously received clofarabine. 8. Patients who are currently participating in other investigational drug studies or having received other investigational drugs within the previous 30 days. 9. Blast transformation of chronic myeloid leukaemia or acute promyelocytic leukaemia.
    1. Pazienti con infezione sistemica non controllata considerata opportunistica, che porta a pericolo di vita o clinicamente significativa al momento del trattamento. 2 Pazienti con disturbi psichiatrici che possono interferire con le procedure di consenso, partecipazione allo studio o follow up. 3. Pazienti che stanno ricevendo altri chemioterapici o corticosteroidi (a meno che quest'ultimi siano somministrati a bassa dose come pre.medicazione o trattamento di condizioni croniche come l'artite reumatoide). 4. Pazienti che hanno ricevuto un precedente trattamento per la leucemia. Pazienti che hanno ricevuto fattori di crescita, terapia di supporto con citochine, leucoferesi o idrossiurea sono arruolabili nello studio ma devono aver interrotto la terapia almeno 24 ore prima dell'inizio del trattamento con clofarabina. 5. Pazienti con alter patologie concomitanti gravi (Coronaropatia (CAD), disturbi neurologici significativi, diabete non controllato, etc), per i quali, secondo il parere dello sperimentatore, rendono l'inserimento del paziente nello studio non appropraito 6. Pazienti con coinvolgimento sintomatico del Sistema Nervoso Centrale (CNS) 7. Pazienti che hanno ricevuto precedentemente clofarabina 8. Pazienti che stanno partecipando in latri studi con farmaci sperimentali o che hanno ricevuto farmaci sperimentali nei 30 giorni precedenti.. 9. Trasformazione dei blasti della leucemia mieloide cronica o della leucemia promielocitica acuta.
    E.5 End points
    E.5.1Primary end point(s)
    Tumor response, toxicity
    Risposta tumorale, tossicita`
    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 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) 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.8.6 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 Information not present in EudraCT
    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 years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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 No
    F.3.3.1Women of childbearing potential not using contraception No
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 65
    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 Decision2005-03-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-03-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-12-16
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