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    Summary
    EudraCT Number:2004-004527-35
    Sponsor's Protocol Code Number:BIOV-121
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-03-08
    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 ConcernedIreland - HPRA
    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.4.1Sponsor's protocol code numberBIOV-121
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    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 Information not present in EudraCT
    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 nameClofarabine
    D.3.2Product code FP028
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 NA
    D.3.9.2Current sponsor codeClofarabine
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee 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 Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 Leukaemia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.1
    E.1.2Level LLT
    E.1.2Classification code 10000880
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the overall response (OR) rate of older patients with untreated AML, for whom intensive chemotherapy is not considered suitable, when given clofarabine at the study dose schedule. 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.
    E.2.2Secondary objectives of the trial
    1. To document the rate of CR(s) in the study population.
    2. To document the rate of CRi(s) in the study population.
    3. To document the rate of PR(s) in the study population.
    4. To document time to event parameters including duration of remission and overall survival (OS) and time to remission.
    5. To document the safety profile and tolerability of clofarabine for this population and dosing regimen.
    6. To determine the pharmacokinetic profile and intracellular triphosphate levels of clofarabine in the study population.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Patients must have untreated AML as defined by the WHO classification (Appendix I)
    2. Patients must provide written informed consent.
    3. Male or Post-Menopausal female patients ≥ 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 (i.e., latex condom, diaphragm, cervical cap, etc) 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.

    Inclusion Laboratory Values
    Parameter Required Value International Standard (IS units)
    Serum Bilirubin < 1.5 x ULN
    AST and ALT < 2 x ULN
    Creatinine < 1.7g/dL
    Prothrombin Time < 1.5 x control
    ULN = Institutional Upper Limit of Normal.
    E.4Principal exclusion criteria
    Patients who meet any of the following criteria will be excluded from study admission:
    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.
    E.5 End points
    E.5.1Primary end point(s)
    The Primary Efficacy Endpoint is:
    The overall response (OR) rate will be determined by assessment of morphology and blast count from bone marrow aspirates and peripheral blood performed prior to first dose and end of treatment. The OR rate will be defined as the sum of the number of patients in the study population with a CR, CRi or PR divided by the number of patients in the study population.

    Secondary Efficacy Endpoints are:
    ·The CR rate will be determined by dividing the number of patients in the study population with a CR by the total number of patients in the study population.
    ·The CRi rate will be determined by dividing the number of patients in the study population with a CRi by the total number of patients in the study population.
    ·The PR rate will be determined by dividing the number of patients in the study population with a PR by the total number of patients in the study population.
    ·Overall survival (OS) will be calculated from the date of first dose of clofarabine to the date of death.
    ·Duration of remission will be calculated from the date of the first BM aspirate or blood sample which is documented to show remission to the date of the first BM aspirate or haematological analysis sample documented to show disease relapse or death due to any cause, whichever occurs first.
    ·Time to remission will be calculated from the date of first dose to date of first BM aspirate or blood sample which is documented to show remission.
    ·In patients who consent pharmacokinetic parameters and intracellular clofarabine triphosphate levels will be evaluated by standard assay methods.


    Safety endpoints are:
    -Safety and tolerability will be evaluated by the incidence, severity (as assessed by the revised NCI CTCAE, version 3.0 (published 16 April 2003) duration, seriousness, and relationship of adverse events to the study drug occurring from the time the patient is consented until 30 days after the last study dose. All = grade 3 drug-related toxicities will be considered unacceptable toxicity with the following exceptions: nausea and vomiting (if manageable with supportive care measures), alopecia, drug-related fever, lymphopenia, and transient elevations in liver function tests.
    -Haematology (full blood count with differentials),
    Serum chemistry (for liver and renal function tests, including: urea, phosphorus, magnesium, lactate dehydrogenase (LDH), creatinine, uric acid, total protein, albumin, calcium, glucose, total bilirubin, alkaline phosphatase (ALP), AST, ALT, electrolytes (chloride, sodium, potassium, and bicarbonate), BUN and bone marrow aspirations
    -Prothrombin Time
    -Electrocardiogram (ECG).
    -Echocardiogram (ECHO) or Multiple-Gated Acquisition (MUGA) scan if clinically indicated.
    -Chest radiograph, or other imaging studies
    -A complete physical examination and medical history including previous and concurrent baseline conditions (using NCI CTC).
    -Measurements of height (cm) and weight (kg).
    -Karnofsky Performance Status evaluation.
    -Vital signs (blood pressure, pulse rate, respiratory rate, and temperature)
    -Concurrent medication
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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.8.5The 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 Information not present in EudraCT
    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
    The end of the trial is the last patient visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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) No
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 65
    F.4.2.2In the whole clinical trial 65
    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)
    Standard care
    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 Decision2005-05-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-12-21
    P. End of Trial
    P.End of Trial StatusCompleted
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