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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2014-002752-50
    Sponsor's Protocol Code Number:IC2014-10
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-01-07
    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 ConcernedFrance - ANSM
    A.2EudraCT number2014-002752-50
    A.3Full title of the trial
    Phase II clinical trial evaluating the efficacy of the dual inhibition of PIK/Akt/mTor signaling pathway by PF-05212384 (PKI-587) for patients with myeloid neoplasm secondary to chemo-radiotherapy (t-AML/MDS) or de novo relapsed or refractory AML
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II clinical trial evaluating the efficacy of PF-05212384 (PKI-587) for patients with myeloid neoplasm secondary to chemo-radiotherapy (t-AML/MDS) or de novo relapsed or refractory AML
    A.3.2Name or abbreviated title of the trial where available
    LAM-PIK
    A.4.1Sponsor's protocol code numberIC2014-10
    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 SponsorINSTITUT CURIE
    B.1.3.4CountryFrance
    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 supportINSTITUT CURIE
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportINCA (Institut National du Cancer)
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportPFIZER
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationINSTITUT CURIE
    B.5.2Functional name of contact pointIsabelle TURBIEZ
    B.5.3 Address:
    B.5.3.1Street Address35 rue Dailly
    B.5.3.2Town/ citySaint-Cloud
    B.5.3.3Post code92210
    B.5.3.4CountryFrance
    B.5.4Telephone number33147 11 16 59
    B.5.5Fax number33147 11 16 58
    B.5.6E-mailisabelle.turbiez@curie.fr
    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 namePF-05212384
    D.3.4Pharmaceutical form Lyophilisate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Myeloid neoplasm secondary to chemo-radiotherapy (t-AML/MDS) /or relapsed or refractory de novo AML /or de novo AML at diagnostic considered unfit to benefit from induction therapy with chemotherapy associated aplasia
    E.1.1.1Medical condition in easily understood language
    Myeloid neoplasm secondary to chemo-radiotherapy /or relapsed or refractory de novo AML /de novo AML unfit from induction therapy
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10066572
    E.1.2Term AML progression
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of PF-05212384 (PKI-587) on the overall response after treatment
    E.2.2Secondary objectives of the trial
    -Tolérance and toxicity
    -Treament compliance
    -PFS and Overall survival
    -Quality of life
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Biological studies will be realized to assess the status of activation ok PI3K/m TOR pathway in patients before they receive the experimental treatment. Then we will determine in vitro the qualitative and quantitative inhibition with PKI-587 to establish a parallel with the clinical response.
    E.3Principal inclusion criteria
    1. Patients belong to one of three categories:
    1.1. Myeloid neoplasm secondary to chemo-radiotherapy (t-AML/MDS) aged 60 and over with unfavorable cytogenetics (ELN definition 2010), the first cancer must have been in remission for more than two years, except in situ carcinoma, basal cell carcinoma and squamous cell carcinoma
    1.2. Relapsed or refractory de novo AML aged 18 and over (multiple relapses allowed), regardless of the risk group, provided not being eligible for allogeneic bone marrow transplantation
    1.3. de novo AML at diagnosis, aged 60 and over and considered unfit to benefit from induction chemotherapy associated with aplasia (at the discretion of the investigator)
    2. Adequate glycemic balance defined by glycated hemoglobin (HbA1c) ≤ 8%
    3. Females of childbearing potential (FCBP) should receive effective contraception: a negative pregnancy blood test is required within 2 weeks before starting experimental treatment.
    4. ECOG/performance status ≤ 2
    5. Absence of severe or active infection
    6. Adequate systolic cardiac function (LVEF ≥ 50%)
    7. Adequate hepatic function: AST and ALT ≤ 3 times the upper limit of normal (ULN), bilirubin ≤ 1.5 x ULN
    8. Adequate renal function: serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance > 60 ml/min.
    9. Signed informed consent
    E.4Principal exclusion criteria
    1. Glucose intolerance or diabetes mellitus, treated or untreated
    2. First cancer in evolution(solid tumor or lymphoma) or in remission for less than two years, except in situ carcinoma, basal cell carcinoma and squamous cell carcinoma
    3. AML secondary to MDS or myeloproliferative syndrome (WHO 2008 definitions)
    4. Acute promyelocytic leukaemia (APL or AML FAB3) de novo or secondary to treatment (t-APL)
    5. de novo or secondary CBF/AML
    6. de novo or secondary Ph1 positive AML defined by the presence of a t(9.22) or a BCR-ABL transcript
    7. Leukocytes above 30.000/mm3 (30 G/L) at enrollment
    8. Antileukemic treatment within 15 days before enrollment, with the exception of hydroxyurea
    9. Central nervous system leukemic involvement
    10. Pregnant or lactating women, or women of childbearing potential without effective contraception
    11. Prior history of allogeneic bone marrow transplantation
    12. Prior history of organ transplantation or other cause of severe or chronic immunodeficiency
    13. Seropositivity for HIV or HTLV-1 viruses, active B or C hepatitis
    14. Inclusion in another experimental anti-cancer clinical trial*
    15. Patients unable to undergo medical monitoring for geographical, social or psychological issues
    16. Patient under measure of legal protection
    17. No social security
    E.5 End points
    E.5.1Primary end point(s)
    The overall response rate will be assessed according to the IWG AML and MDS criteria (by Cheson BD). The primary endpoint will be the rates of CR + CRu + PR evaluated.
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 months after inclusion
    E.5.2Secondary end point(s)
    -Tolerance and toxicity NCI CTCAE V4 scoring system
    -Treatment compliance will be evaluated by the ratio between the number of cycles administered on the expected number of cycles and deadlines between treatment cycles.
    -Progression Free Survival will be calculated from the date of inclusion until progression or death and the Overall survival will also be calculated from the date of inclusion to de date of death.
    -Quality of life using QLQ-C30 EORTC

    E.5.2.1Timepoint(s) of evaluation of this end point
    -Tolerance and toxicity during treatment
    -Treatment compliance during treatment
    -Duration of response PFS at one year
    -Overall survival (date of death)
    -Quality of Iife at the end of induction and maintenance therapy
    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 Yes
    E.6.13.1Other scope of the trial description
    Biological analyses to establish predictive biological criteria for the clinical response to the experimental treatment.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    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.8.4.1Number of sites anticipated in Member State concerned9
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 39
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 39
    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 state39
    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)
    Regular clinical, biological and radiological monitoring
    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 Decision2014-11-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-04-26
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