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    Summary
    EudraCT Number:2008-002160-34
    Sponsor's Protocol Code Number:ELP1020
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-09-04
    Trial 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 ConcernedUK - MHRA
    A.2EudraCT number2008-002160-34
    A.3Full title of the trial
    Aezea™ (cenersen) in combination with chemotherapy for the treatment of refractory acute myelogenous leukemia subjects ≥ 55 years of age with inadequate response to a single frontline induction course randomized double-blind placebo-controlled multi-center study
    A.4.1Sponsor's protocol code numberELP1020
    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 SponsorEleosInc 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/3/06/416
    D.3 Description of the IMP
    D.3.1Product namecenersen
    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 IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcenersen
    D.3.9.1CAS number 872847-66-0
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Refractory 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 10000884
    E.1.2Term Acute myeloid leukaemia NOS
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to determine if using cenersen along with four cycles of alternating high and low-dose chemotherapy improves the complete response (CR) rate in AML patients ≥ 55 years of age showing inadequate response (CR, CRi, or MLFS) to a single aggressive frontline induction course (as defined in the protocol).
    E.2.2Secondary objectives of the trial
    Overall Survival; Safety Profile; Complete Remission (CR) + Complete Remission with Incomplete Blood Count Recovery (CRi) Rate; Morphologic Leukemia-Free State (MLFS) Rate; Partial Remission Rate (PR); Remission Duration (RD); Early Deaths measured as deaths at 30, 60 and 90 days of the start of treatment; Time to Neutrophil and Platelet Recovery; Death in CR; and Quality of Life using EORTC QLQ-C30 QOL Questionnaire and Zubrod score
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. In response to their initial first course of frontline treatment, patients who did not achieve a response (CR, CRi, or MLFS): a. have ≥15% bone marrow blasts in a BM specimen at day 14 - 30 from the initiation of the initial frontline treatment course. If within that timeframe the BM is hypoplastic, the BM assessment can be repeated within a subsequent two-week period and the patient entered into the study if there is ≥15% blasts in the bone marrow.
    2. ≥ 55 years old.
    3. Have an understanding of the importance of not taking prohibited substances (paracetamol [acetaminophen] or antioxidants) and contract not to do so during the proscribed periods.
    4. Have a life expectancy of more than 4 weeks following initiation of treatment.
    5. Zubrod performance status ≤2.
    6. Have recovered from acute toxicities of prior chemotherapy (≤ Grade 2).
    7. Have signed an informed consent.
    8. Total bilirubin ≤1.5 x upper normal limit (UNL) and Alanine Amino Transferase [ALT (Serum Glutamic-pyruvic Transaminase (SGPT))] ≤2.5 x UNL.
    9. Creatinine ≤1.5 x UNL.
    10. Serum magnesium should be within the normal range (Mg replacement being acceptable).
    11. Left Ventricular Ejection Fraction (LVEF) of >50% as determined by multiple-gated acquisition scan (MUGA) or Echocardiogram (ECHO).
    12. Ability to receive all courses of therapy, as outlined in the treatment schedules at the investigative site.
    13. Willingness to comply with scheduled follow-up as required by the protocol.
    14. Use of adequate contraceptive techniques if premenopausal and sexually active.
    15. If premenopausal, have negative pregnancy tests at screening. The pregnancy test results must be known prior to enrollment.

    Note: Induction course for frontline treatment must involve standard or high-dose chemotherapy. For induction regimens involving the use of ara-C in the ≥100 to <1000 mg/m2/day range the ara-C must have been given for at least 7 days. Induction courses of ara-C of 1000 mg/m2/day or greater for at least 3 days within a 7 day period are acceptable. Alternatively, subjects who have received an induction regimen involving the use of the experimental AML agent clofaribine with or without ara-C will be eligible for this study. Other regimens must be pre-approved by the Sponsor prior to the subject entering the trial.
    E.4Principal exclusion criteria
    1. Presence of uncontrolled illness including, but not limited to, ongoing infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, high blood pressure, history of labile hypertension, history of poor compliance with an antihypertensive regimen, myocardial infarction less than or equal to 6 months prior to registration, diabetes, interstitial pneumonia or extensive and symptomatic interstitial fibrosis of lung, chronic liver disease or psychiatric illness/social situations that limits compliance with study requirements.
    2. Aplastic or hypoplastic BM.
    3. Acute promyelocytic leukemia (APL).
    4. Requirement for transplant before Course 2 is complete.
    5. Concurrent use of other investigational agents (i.e., drugs not approved for clinical indications) or having received other investigational agents within the 30 days prior to the start of Course 1. However, individual cases may be considered by the Sponsor on a case-by-case basis (e.g., administration of agents used in supportive care).
    6. Pregnancy (includes a positive pregnancy test at the screening visit) or lactation.
    7. Known HIV infection.
    8. Active hepatitis B or C or other active liver disease.
    9. Presence of dyspnea at rest or with minimal exertion after correction for anemia. This is an observational assessment by the physician determined at the time of medical examination.
    10. Known or suspected hypersensitivity or allergy to idarubicin or ara-C.
    11. Occurrence of major surgery within two weeks of the start of Course 1. However, individual cases may be considered by the Sponsor on a case-by-case basis.
    12. Chemotherapy within two weeks prior to initiation of therapy under this protocol, or hydroxyurea within 7 days.
    13. Patients who, with appropriate explanation, are not prepared to commit to total avoidance of the use of paracetamol (acetaminophen) or paracetamol-containing medications during the proscribed periods (24 hours before the start of cenersen infusion (day minus 1) through the end of Course 2 (total of 57-70 days) and for one day before through the end of each of Courses 3 or 4). Non-paracetamol antipyretics and analgesics are permitted.
    14. Patients not prepared to commit to the exclusion of antioxidants during times proscribed in the protocol extending from 24 hours before the start of cenersen infusion (day minus 1) through the end of chemotherapy administration for that cycle or course.
    15. Medical or psychiatric conditions that compromise the ability to give informed consent, to comply with the protocol or to complete the study.
    16. Inability, in the opinion of the principal investigator or clinical staff, to comply with protocol requirements for the duration of the study.
    E.5 End points
    E.5.1Primary end point(s)
    Complete Remission (CR) Rate
    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 Yes
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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.8.4.1Number 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 EEA15
    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 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
    Completion of last patient last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months24
    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.1.3Elderly (>=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 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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 90
    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)
    Follow-up data will be collected for all study patients every 3 months for 3 follow-up visits, then every 6 months out to 24 months from the introduction of treatment. Follow-up for each patient is not intended to exceed 24 months (2 years).
    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 Decision2008-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-10-24
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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