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    Summary
    EudraCT Number:2009-013669-25
    Sponsor's Protocol Code Number:AEG35156-206
    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:2009-10-05
    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 ConcernedGermany - BfArM
    A.2EudraCT number2009-013669-25
    A.3Full title of the trial
    An Open-Label Randomized Phase 2 Study of the X-Linked Inhibitor of Apoptosis (XIAP) Antisense AEG35156 Given in Combination with High-dose Cytarabine and Idarubicin in AML Following Failure of a Single Standard Dose Cytarabine Based Frontline Induction Regimen.
    A.4.1Sponsor's protocol code numberAEG35156-206
    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 SponsorAegera Therapeutics Inc.
    B.1.3.4CountryCanada
    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 nameAEG35156
    D.3.2Product code AEG35156
    D.3.4Pharmaceutical form Powder 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.3.8INN - Proposed INNd(P-thio)[(2'-O-Me)(rU-rG-rC-rA)-C-C-C-T-G-G-A-T-A-C-C-(2'-O-Me)(rA-rU-rU-rU)]
    D.3.9.2Current sponsor codeAEG35156
    D.3.9.3Other descriptive nameAntisense Oligonucleotide to human XIAP
    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 Yes
    D.3.11.13.1Other medicinal product typeAntisense oligonucleotide
    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.2.5The 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 nameIdarubicine
    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.3.8INN - Proposed INNIDARUBICIN
    D.3.9.1CAS number 58957929
    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 Yes
    D.3.11.13.1Other medicinal product typeAntineoplastic Agent
    D.IMP: 3
    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.2.5The 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 nameCytarabine
    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 INNCYTARABINE
    D.3.9.1CAS number 147-94-4
    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 Yes
    D.3.11.13.1Other medicinal product typeAntineoplastic Agent
    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 after failure of a single standard dose cytarabine based frontline induction regimen.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10001941
    E.1.2Term AML
    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 if AEG35156 can enhance the combined complete remission (CR) and
    CR with incomplete platelet recovery (CRp) rate of high-dose cytarabine and
    idarubicin in AML following failure of a single standard dose cytarabine based
    frontline induction regimen.

    - To determine if AEG35156 can enhance response duration following high-dose
    cytarabine and idarubicin in AML following failure of a single standard dose
    cytarabine based frontline induction regimen.
    E.2.2Secondary objectives of the trial
    - To determine if AEG35156 can enhance overall survival following high-dose
    cytarabine and idarubicin in AML following failure of a single standard dose
    cytarabine based frontline induction regimen.

    - To determine the safety of adding AEG35156 to high-dose cytarabine and idarubicin
    in AML following failure of a single standard dose cytarabine based frontline
    induction regimen.

    - To study the pharmacokinetics of AEG35156 when used in combination with
    cytarabine and idarubicin
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients with AML, except those with APL (acute promyelocytic leukemia), failing a
    single standard dose cytarabine based frontline induction regimen. The diagnosis of
    refractory AML is based on the presence of either > 10% blasts in marrow or blood
    or 5-10% blasts in either site together with cytopenia (Hb < 10 g/dL, or platelets <
    100 x 10^9/L, or neutrophil count < 1.0 x 10^9/L).
    - Patients must have an Eastern Cooperative Oncology Group (ECOG) performance
    status of ≤2.
    - Patients must be ≥18 years old.
    - Male, or female patients who are post-menopausal (amenorrhagic for at least 12
    months), or surgically or biologically sterile. Females of childbearing potential
    must have a negative serum pregnancy test within 72 hours prior to the 1st
    infusion in the study and using adequate forms of contraception for the duration of
    the study, including 30 days after the last treatment. Males should avoid fathering
    children during the course of the study. Patients and their partners with
    reproductive potential must use an effective contraceptive method while the
    patient is on the study treatment and for 30 days after the last treatment.
    Adequate methods of contraception are double barrier methods (condoms with
    spermicidal jelly or foam, and diaphragm with spermicidal jelly or foam), oral, depot
    and injectable contraceptives, IUD, and surgical sterilization. Single barrier
    methods, rhythm methods, abstinence or sterility of a partner will not be
    considered adequate contraception.
    - Patients must have adequate organ and immune function as indicated by the
    following laboratory values:
    Parameter Laboratory Values
    Serum creatinine; ≤2.0 mg/dL (≤177 μmol/L)
    Total Bilirubin ≤2.0 mg/dL (≤34 μmol/L)
    AST (SGOT) and ALT (SGPT) ≤3 X ULN *
    *ULN: Institution’s upper limit of normal.
    - The patient must understand, be able and willing and likely to fully comply with
    study procedures, including scheduled follow-up, and restrictions.
    E.4Principal exclusion criteria
    - Clinical evidence of ongoing grade 3 or 4 non-hematological toxicities from the
    initial standard dose cytarabine-based induction chemotherapy.
    - Patients with a prior history of peripheral neuropathy of grade 2 or higher.
    - Clinical evidence of active CNS leukemic involvement.
    - Active and uncontrolled infection. Patients with an infection who are under active
    treatment with antibiotics and whose infections are controlled may be entered to
    the study.
    - Current evidence of invasive fungal infection (blood or tissue culture).
    - Current evidence of an active second malignancy except for non-melanoma skin
    cancer.
    - Uncontrolled medical problems, unrelated to the malignancy, or of sufficient severity
    that in the opinion of the investigator, impair a patient’s ability to give informed
    consent or unacceptably reduce the safety of the proposed treatment.
    - Neurological or psychiatric disorders that would interfere with consent or study
    follow-up.
    - Known or suspected intolerance or hypersensitivity to the study drugs [or closely
    related compounds] or any of their stated ingredients. Study drugs being the
    antisense, cytarabine and idarubicin.
    - History of alcohol or other substance abuse within the last year.
    - Use of another investigational agent within the last 14 days prior to enrolment.
    Patients who have received a previous antisense agent in the last 90 days will be
    excluded.
    - Female patients who are pregnant, lactating, or with a positive pregnancy test at
    screening must be excluded.
    - Patients who have previously been enrolled into this study and subsequently
    withdrawn must also be excluded.

    Both men and women and members of all races and ethnic groups are eligible for
    this trial.
    E.5 End points
    E.5.1Primary end point(s)
    - To determine if AEG35156 can enhance the combined complete remission (CR) and
    CR with incomplete platelet recovery (CRp) rate of high-dose cytarabine and
    idarubicin in AML following failure of a single standard dose cytarabine based
    frontline induction regimen.
    - To determine if AEG35156 can enhance response duration following high-dose
    cytarabine and idarubicin in AML following failure of a single standard dose
    cytarabine based frontline induction regimen.
    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 Yes
    E.6.7Pharmacodynamic No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    comparison between chemotherapy + study drug AEG35156 versus chemotherapy alone
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    End of trial is defined as LPLV (Last Patient Last Visit)
    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
    E.8.9.2In all countries concerned by the trial years2
    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 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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 60
    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)
    In responding patients (CR/CRp patients), consolidation chemotherapy and/or allogeneic
    hematopoietic stem cell transplantation will be administered at the Investigator’s
    discretion.
    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 Decision2009-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-11-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2010-05-18
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