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    Summary
    EudraCT Number:2009-010114-30
    Sponsor's Protocol Code Number:D1531C00009
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-04-09
    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 ConcernedGermany - BfArM
    A.2EudraCT number2009-010114-30
    A.3Full title of the trial
    A randomised, open-label, multi-centre, 2-stage, parallel group study to assess the efficacy, safety and tolerability of AZD1152 alone and in combination with low dose cytosine arabinoside (LDAC) in comparison with LDAC alone in patients aged ≥ 60 with newly diagnosed acute myeloid leukaemia (AML) who are considered unsuitable to receive intensive induction chemotherapy regimens
    A.4.1Sponsor's protocol code numberD1531C00009
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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/3/08/590
    D.3 Description of the IMP
    D.3.1Product nameAZD1152 100mg Lyophile
    D.3.2Product code AZD1152
    D.3.4Pharmaceutical form Powder and solvent for 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.3.9.1CAS number 722543-31-9
    D.3.9.2Current sponsor codeAZD1152 Hydrate
    D.3.9.3Other descriptive nameAZD1152 Pure
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 No
    D.3.11.8Extractive medicinal product No
    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.IMP: 2
    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.2.1.1.1Trade name Cytarabine 20 mg/ml Injection
    D.2.1.1.2Name of the Marketing Authorisation holderMayne Pharma plc
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameLow dose cytosine arabinoside
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcytarabine
    D.3.9.1CAS number 147-94-4
    D.3.9.3Other descriptive namecytosine arabinoside
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 No
    D.3.11.8Extractive medicinal product No
    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 Leukemia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10000880
    E.1.2Term Acute myeloid leukaemia
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Stage 1:
    The primary objective of Stage 1 is to make a preliminary assessment of the relative efficacy of AZD1152 monotherapy compared to low dose cytosine arabinoside (cytarabine, LDAC) by assessment of Overall Complete Response Rate (OCRR).

    The outcome of Stage 1 will inform the decision as to whether the trial should continue to Stage 2.

    Stage 2:
    The primary objective of Stage 2 is to determine the relative efficacy of AZD1152, both alone, and in combination with LDAC compared to LDAC alone by assessment of OCRR.
    E.2.2Secondary objectives of the trial
    Stage 1: AZD1152 monotherapy compared to LDAC
    1. To assess the efficacy by assessment of Overall Survival (OS), Duration of Response (DoR), Disease-free Survival (DFS) and Time to Complete Response (TTCR).
    2. To assess the effects on
    a) patients’ health related quality of life (HRQoL) and disease-related symptoms
    b) the number of key healthcare cost-generating events
    c) the requirement for key healthcare interventions
    3. Safety/tolerability

    Stage 2: AZD1152, alone and in combination with LDAC, compared to LDAC alone
    1. To determine the efficacy by assessment of OS, DoR, DFS and TTCR
    2. To assess the effects on
    a) HRQoL and disease-related symptoms
    b) the number of key healthcare cost-generating events
    c) the requirement for key healthcare interventions
    3. Safety/tolerability

    Stage 1 and 2: To determine the population PK of AZD1152 and AZD1152 hQPA, and to assess the relationship between PK and measures of PD response, efficacy and AEs in patients with AML
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of written informed consent prior to any study specific procedures
    2. Newly diagnosed male or female patients aged ≥ 60 years
    3. De Novo (primary) or Secondary AML
    4. Not eligible for intensive induction with anthracycline-based combination chemotherapy as a result of at least one of the following:
    - Age ≥75 years
    - Adverse cytogenetics, e.g., as defined by the MRC Prognostic Groupings Grimwade et al 2001)
    - WHO performance status >2
    - Organ dysfunction arising from significant co-morbidities not directly linked to leukaemia
    5. World Health Organisation (WHO) performance status 0-3 (WHO
    performance status 3 is only acceptable if solely attributed to the
    underlying leukaemia)
    6. Serum bilirubin ≤ 1.5 x Upper Limit of Normal (ULN) unless considered due
    to leukaemic organ involvement (Gilbert’s or related syndrome allowed)
    7. Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase
    (ALT/SGPT) ≤ 2.5 x ULN, unless considered due to leukaemic organ
    involvement
    8. Serum creatinine ≤ 1.5 x ULN or 24-hour creatinine clearance > 50 mL/min
    (measured or calculated by Cockcroft-Gault)
    9. Likely ability to complete 3 cycles (12 weeks) of treatment
    10. Evidence of post-menopausal status, or negative urinary or serum
    pregnancy test for female pre-menopausal patients.
    E.4Principal exclusion criteria
    1. Involvement in the planning and/or conduct of the study (applies to both
    AstraZeneca staff and/or staff at the study site and/or agents for
    AstraZeneca)
    2. Previous randomisation of treatment in the present study
    3. Participation in another clinical study in which an investigational product
    was received within 14 days before the first dose in this study, or at any
    time if the patient has not recovered from side-effects associated with
    that investigational product (to CTCAE Grade 1 or baseline, except
    alopecia)
    4. Administration of LDAC is clinically contraindicated
    5. Patients with AML of FAB M3 classification Acute Promyelocytic Leukaemia
    (APL)
    6. Patients with blast crisis of chronic myeloid leukaemia
    7. Mean QTc interval ≥ 470ms calculated from 3 ECGs using Fridericia’s or
    Bazett’s Correction
    8. Any chemotherapy e.g. for prior MDS, apart from hydroxyurea or
    intrathecal chemotherapy for CNS disease (see Section 6.4), or
    radiotherapy within 14 days prior to starting the study (not including
    palliative radiotherapy at local sites)
    9. Persistent, chronic, clinically significant toxicities, from any prior anti-cancer
    therapy greater than CTCAE Grade 1 (except alopecia)
    10. Patients with symptomatic clinically defined central nervous system (CNS)
    disease due to leukaemic infiltration (asymptomatic patients are eligible if
    symptom free for > 10 days)
    11. Uncontrolled intercurrent illness including, but not limited to active
    infection, symptomatic congestive heart failure, cardiac arrhythmia, or
    psychiatric illness/social situations which would limit compliance with
    protocol requirements
    12. Major surgery within 4 weeks prior to entry into the study (excluding the
    placement of vascular access) that involved general anaesthesia or
    respiratory assistance
    13. Patients with documented cases of human immunodeficiency virus (HIV) or
    hepatitis B or C
    14. Female patients who are breast feeding, or patients of reproductive
    potential not employing an effective method of birth control
    15. History of hypersensitivity to active or inactive excipients of any study
    medication (AZD1152 or LDAC)
    E.5 End points
    E.5.1Primary end point(s)
    Overall Complete Response Rate (OCRR), defined as the proportion of patients achieving a Complete Remission (CR) or confirmed CRi (complete remission with incomplete recovery of neutrophils or platelets sustained at 2 consecutive assessments)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Information not present in EudraCT
    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 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 No
    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 EEA14
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    The end of the entire study is defined as ”the last visit of the last patient undergoing the trial”.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 420
    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 Decision2009-06-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-06-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2012-04-26
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