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    Summary
    EudraCT Number:2011-002365-37
    Sponsor's Protocol Code Number:3066K1-1165
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-01-18
    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 number2011-002365-37
    A.3Full title of the trial
    A double-blind, placebo-controlled, randomized, multicenter phase II trial to assess the efficacy of temsirolimus added to standard primary therapy in elderly patients with newly diagnosed AML
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A double-blind, placebo-controlled, randomized, multicenter phase II trial to assess the efficacy of temsirolimus added to standard primary therapy in elderly patients with newly diagnosed AML
    A.3.2Name or abbreviated title of the trial where available
    TOR-AML
    A.4.1Sponsor's protocol code number3066K1-1165
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01611116
    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 SponsorJ.W. Goethe-University
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPfizer Pharma GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJ.W. Goethe University Hospital
    B.5.2Functional name of contact pointStudienzentrale Hämatologie
    B.5.3 Address:
    B.5.3.1Street AddressTheodor-Stern-Kai 7
    B.5.3.2Town/ cityFrankfurt / Main
    B.5.3.3Post code60590
    B.5.3.4CountryGermany
    B.5.4Telephone number00496963016366
    B.5.5Fax number00496963017463
    B.5.6E-mailbrandts@em.uni-frankfurt.de
    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 Yes
    D.2.1.1.1Trade name Torisel
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Concentrate and solvent for 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 INNTEMSIROLIMUS
    D.3.9.1CAS number 162635-04-3
    D.3.9.4EV Substance CodeSUB21308
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 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 infusion
    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
    Patients with newly diagnosed AML (except APL) according to the FAB and WHO classification, including AML evolving from MDS and AML after previous cytotoxic therapy or radiation (secondary AML)

    Bone marrow aspirate or biopsy must contain ≥ 20% blasts of all nucleated cells, with the exception of AML FAB M6, where ≥ 30% of non-erythroid cells must be leukemic blasts

    Age ≥ 61 years
    E.1.1.1Medical condition in easily understood language
    Patients with newly diagnosed Acute Myeloblastic Leukemia
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10000878
    E.1.2Term Acute myeloblastic leukemia
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to compare the median Event Free Survival (EFS)* and the EFS probability of all AML patients between the temsirolimus and the control group

    * EFS defined as: Time interval from day 1 of study treatment until treatment failure, relapse from CR or CRi, or death from any cause, whichever occurs first. The time point at which the patient is resistant to therapy or survives induction without a CR, CRi or morphologic leukemia-free state will be recorded.
    E.2.2Secondary objectives of the trial
    compare
    • median Event Free Survival of patients with different cytogenetic and molecular risk groups (RG)
    • rate of early response after 1st induction of Temsirolimus group (TOR-G) vs control group (CG)
    • rate of early response after 1st induction of patients with different cytogenetic and mol. RG
    • CR rate of TOR-G vs CG
    • CR rate of patients with different cytogenetic and mol. RG
    • Relapse Free Survival (RFS) of TOR-G vs CG
    • RFS of patients with different cytogenetic and mol. RG
    • Overall Survival (OS) of TOR-G vs CG
    • OS of patients with different cytogenetic and mol. RG
    • rate of mol. remissions of TOR-G vs CG
    • toxicity of TOR-G and control treatment
    • rate of mol. relapse after mol. remission of TOR-G vs CG after induction therapy and during 1st remission

    • Evaluation of biomarkers indicating the course of disease, incl. genetic, epigenetic, transcriptional and protein markers, indicators of autophagy in leukemic blasts, bone marrow, periph. blood cells, serum and plasma
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients with newly diagnosed AML (except APL) according to the FAB classification, including AML evolving from MDS or other hematological diseases and AML after previous cytotoxic therapy or radiation (secondary AML).
    • Bone marrow aspirate or biopsy must contain ≥ 20% blasts of all nucleated cells or differential blood count must contain ≥ 20% blasts. In AML FAB M6 ≥ 30% of non-erythroid cells in the bone marrow must be leukemic blasts. In AML defined by cytogenetic aberrations the proportion of blasts may be < 20%.
    • Age ≥ 61 years
    • Informed consent, personally signed and dated to participate in the study
    • Willingness of male subjects whose sexual partners are women of child-bearing potential (WOCBP), to use an effective form of contraception (pearl index < 1%) during the study and at least 6 months thereafter. Effective forms of contraception are complete sexual abstinence, combined oral contraceptive, hormone IUCD, vaginal hormone ring, transdermal contraceptive patch, contraceptive implant or depot contraceptive injection in combination with a second method of contraception like a condom or a cervical cap / diaphragm with spermicide or surgical sterilisation (vasectomy) in male patients. WOCBP are defined as sexually mature women who have not undergone a hysterectomy or surgical sterilization or who have not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months).
    E.4Principal exclusion criteria
    • Patients who are not eligible for standard chemotherapy as described in chapter 6.2
    • Previous treatment for AML, except leukapheresis for patients with hyperleukocytosis (leukocytes > 100,000/uL and / or leukostatic syndrome) or hydroxyurea
    • Known central nervous system manifestation of AML
    • Cardiac Disease: Heart failure NYHA III° or IV°; active coronary artery disease (MI more than 6 months prior to study entry is permitted); serious cardiac ventricular arrhythmias, defined as: ventricular extrasystoly grade LOWN IV, sustained or non-sustained ventricular tachycardias, and history of ventricular fibrillation / ventricular flutter, unless patient is protected by an internal cardioverter / defibrillator or ventricular arrhythmia was attributable to a myocardial ischemia > 6 months before study entry.
    • Chronically impaired renal function (creatinin clearance < 30 ml / min)
    • Chronic pulmonary disease with relevant hypoxia
    • Inadequate liver function (ALT and AST ≥ 2.5 x ULN) if not caused by leukemic infiltration
    • Total bilirubin ≥ 1.2 mg/dL if not caused by leukemic infiltration
    • Uncontrolled active infection
    • Concurrent malignancies other than AML with an estimated life expectancy of less than two years and requiring therapy
    • Known HIV and/or hepatitis C infection
    • Evidence or history of CNS disease, including primary or metastatic brain tumors, seizure disorders
    • History of organ allograft
    • Concomitant treatment with kinase inhibitors, angiogenesis inhibitors, calcineurin inhibitors and Mylotarg
    • Serious, non-healing wound, ulcer or bone fracture
    • Allergy to study medication or excipients in study medication
    • Investigational drug therapy outside of this trial during or within 4 weeks of study entry
    • Any severe concomitant condition which makes it undesirable for the patient to participate in the study or which could jeopardise compliance with the protocol
    E.5 End points
    E.5.1Primary end point(s)
    Run-In-Part
    • optimal temsirolimus dose and schedule for the main part of the study

    Main Part
    • median Event Free Survival (EFS) and EFS probability
    E.5.1.1Timepoint(s) of evaluation of this end point
    Run-In-Part
    at the end of the run-in-part

    Main Part
    at the end of the phase II main part (approx. three years after study start)
    E.5.2Secondary end point(s)
    • rate of early response (≤ 10% bone marrow blasts on d15) after the first induction cycle of all AML patients
    • complete remission (CR) rate after induction therapy
    • median relapse-free survival (RFS) and RFS probability after reaching CR
    • median Overall Survival (OS) and OS probability
    • rate of molecular remissions and molecular relapses
    • toxicity according to CTC
    • biomarkers indicating the course of disease, including genetic, epigenetic, transcriptional and protein markers as well as indicators of autophagy in leukemic blasts, bone marrow, peripheral blood cells, serum and plasma
    E.5.2.1Timepoint(s) of evaluation of this end point
    at the end of the phase II main part (approx. three years after study start)
    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 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned15
    E.8.5The trial involves multiple Member States No
    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 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
    Last patient last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months6
    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.1.1.1In 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.1.2.1Number of subjects for this age range: 112
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 112
    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 state224
    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)
    no difference from the expected normal treatment of that condition
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-04-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-04-26
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