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    Summary
    EudraCT Number:2012-005241-20
    Sponsor's Protocol Code Number:F14512IN102G1
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-06-24
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2012-005241-20
    A.3Full title of the trial
    Phase I-II study of F14512 in combination with cytarabine in patients 60 years old and older with acute myeloid leukemia.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of F14512 in combination with cytarabine in patients 60 years old and older with acute myeloid leukemia
    A.4.1Sponsor's protocol code numberF14512IN102G1
    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 SponsorPierre Fabre Medicament
    B.1.3.4CountryFrance
    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 supportPierre Fabre Medicament
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPierre Fabre Medicament
    B.5.2Functional name of contact pointMaud brandely
    B.5.3 Address:
    B.5.3.1Street Address45 Place Abel Gance
    B.5.3.2Town/ cityBoulogne-Billancourt
    B.5.3.3Post code92654
    B.5.3.4CountryFrance
    B.5.4Telephone number0033149.10.82.45
    B.5.5Fax number0033149.10.83.30
    B.5.6E-mailmaud.brandely@pierre-fabre.com
    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 nameF14512
    D.3.2Product code F14512
    D.3.4Pharmaceutical form 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 INNF14512
    D.3.9.3Other descriptive nameF14512
    D.3.9.4EV Substance CodeSUB31895
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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.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 Injection Solution 100 mg/ml - 20ml vial
    D.2.1.1.2Name of the Marketing Authorisation holderHospira UK Ltd
    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 namecytarabine
    D.3.4Pharmaceutical form Solution for injection
    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 INNCytarabine
    D.3.9.3Other descriptive nameCYTARABINE
    D.3.9.4EV Substance CodeSUB06880MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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) 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.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.2.1.1.1Trade name Cytarabine Hospira 2000 mg/20 mL Onco-Tain, concentrate for solution for infusion 100mg/mL
    D.2.1.1.2Name of the Marketing Authorisation holderHospira Benelux BVBA
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 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 INNCytarabine
    D.3.9.3Other descriptive nameCYTARABINE
    D.3.9.4EV Substance CodeSUB06880MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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) 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
    The scope of this study is the treatment of patient acute myeloid leukaemia.
    E.1.1.1Medical condition in easily understood language
    The scope of this study is the treatment of patient acute myeloid leukaemia.
    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 PT
    E.1.2Classification code 10000880
    E.1.2Term Acute myeloid leukaemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase I part:
    To determine the maximal tolerated dose (MTD) of F14512 administered as a three-hour daily infusion given for 5 consecutive days in combination with cytarabine 1 g/m²/day for 5 consecutive days in patients 60 years old or older with refractory or relapsing AML.

    Phase II part:
    To evaluate the efficacy of F14512 in combination with cytarabine (rate of CR and CRi) in AML patients 60 years old and older in first relapse or with refractory disease.
    E.2.2Secondary objectives of the trial
    Phase I part:
    - To determine the recommended dose (RD) of F14512 in combination with cytarabine to be used in the Phase II part,
    - To assess the safety of F14512,
    - To assess the molecular, biologic and clinical effects of F14512 in combination with cytarabine,
    - To assess the pharmacokinetics of F14512 in combination with cytarabine.

    Phase II part:
    - To extend the evaluation of safety at the RD,
    - To assess Relapse-Free Survival, Progression-Free Survival, remission duration and Overall Survival,
    - To assess the molecular, biologic and clinical effects of F14512 in combination with cytarabine,
    - To assess the pharmacokinetics of F14512 in combination with cytarabine at recommended dose.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must satisfy all the following inclusion criteria before they are allowed to participate in the study:

    - Cytogenetically and molecularly characterized AML according to WHO classification (excluding acute promyelocytic leukemia),

    - De novo or secondary AML arising from myelodysplastic syndrome or myeloproliferative syndrome or therapy-related (if the patient is cancer-free for at least 3 years excluding non-melanoma skin cancer) who meets the following criteria:

    Phase I part:
    -Refractory AML after failure of one induction chemotherapy regimen or who had recurrence of disease < 3 months after CR,
    -Relapsed AML: recurrence of disease superior or equal to 3 months after CR,

    Phase II part:
    - Refractory AML after failure of one induction chemotherapy regimen or who had recurrence of disease < 3 months after CR.
    - First relapse after a first CR or CRi lasting at least 3 months but less than 24 months

    - 60 years of age or older,
    - WHO performance status inferior or equal to 2,
    - Adequate liver function tests defined as total bilirubin inferior or equal Upper Limit of Normal (ULN), AST and ALT inferior or equal 3 x ULN,
    - Adequate renal function defined as serum creatinine inferior or equal 1.5 x ULN,
    - Left Ventricular Ejection Fraction (LVEF) superior or equal 45% measured by radionuclide angiography (MUGA scan) or bidimensional echography,
    - No prior therapy for AML for 2 weeks before study entry and patients must have recovered from any treatment-related toxicities. Prior therapy with etoposide for prior solid tumour or AML is allowed. In case of rapidly progressive disease, the use of hydroxyurea in order to control the peripheral blood cell count is allowed; in this case, hydroxyurea should be discontinued at least 48 hours before the start of study treatment,
    - Fertile men must be using an effective method of birth control throughout the study period and for up to 3 months after the last dose of study treatment if their partners are women of childbearing potential,
    - The patient must have access to social insurance,
    - Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial,
    - The patient must give written (personally signed and dated) informed consent before completing any study-related procedure which means assessment or evaluation that would not form part of the normal medical care of the patient.
    E.4Principal exclusion criteria
    If any of the following apply, the patient must not enter the study:
    - Patient candidate for allograft at study entry,
    - Acute promyelocytic leukaemia,
    - Clinical symptoms suggesting active central nervous system leukaemia,
    - Peripheral blast count superior or equal to 30.000/mm3,
    - Severe complication of leukaemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, disseminated intravascular coagulation,
    - Current active infection; serious concurrent, uncontrolled medical disorder,
    - Thrombocytopenia refractory to platelet transfusion,
    - Prior total body irradiation up to more than 12 Gy,
    - Known HIV, HTLV1, Hepatitis B or C positivity,
    - History of another malignancy within the past 3 years except basal cell carcinoma of the skin or carcinoma in situ of the cervix,
    - Active heart disease including myocardial infarction within the previous 6 months, symptomatic coronary artery disease, arrhythmia not controlled by medication or uncontrolled congestive heart failure [New York Heart Association NYHA class III-IV],
    - Clinically relevant cardiovascular, hepatic, neurological or other systemic disease making implementation of the protocol difficult,
    - Concurrent treatment with any other anti-cancer treatment,
    - Participation in another trial of an investigational agent within 30 days before study entry,
    - Known hypersensitivity to the study drug or to drugs with similar chemical structures,
    - Concurrent treatment with inhibitors of ornithine decarboxylase or polyamine analogues,
    - Chronic treatment with systemic or inhaled steroids.
    E.5 End points
    E.5.1Primary end point(s)
    Phase I part:
    To determine the maximal tolerated dose (MTD) of F14512 administered as a three-hour daily infusion given for 5 consecutive days in combination with cytarabine 1 g/m²/day for 5 consecutive days in patients
    60 years old or older with refractory or relapsing AML.

    Phase II part:
    To evaluate the efficacy of F14512 in combination with cytarabine (rate of CR and CRi) in AML patients 60 years old and older in first relapse or with refractory disease.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase I part:
    Dose escalation of F14512 will be stopped once the MTD is reached.
    Phase II part:
    Up to a maximum of 5 cycles at investigator's discretion
    E.5.2Secondary end point(s)
    Phase I part:
    - To determine the recommended dose (RD) of F14512 in combination with cytarabine to be used in the Phase II part,
    - To assess the safety of F14512,
    - To assess the molecular, biologic and clinical effects of F14512 in combination with cytarabine,
    - To assess the pharmacokinetics of F14512 in combination with cytarabine

    Phase II part:
    - To extend the evaluation of safety at the RD,
    - To assess Relapse-Free Survival, Progression-Free Survival, remission duration and Overall Survival,
    - To assess the molecular, biologic and clinical effects of F14512 in combination with cytarabine,
    - To assess the pharmacokinetics of F14512 in combination with cytarabine at recommended dose.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Phase I part:
    Dose escalation of F14512 will be stopped once the MTD is reached.
    Phase II part:
    Up to a maximum of 5 cycles at investigator's discretion
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase I-II study to evaluate the efficacy of the use of F14512 + cytarabine after MTD determination
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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.8.2.4Number of treatment arms in the trial1
    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.8.5The 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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    Phase I part:
    The end of the study is the date of the last visit of the last treated patient, which is scheduled 60 days after last study drug administration.

    Phase II part:
    The end of study is the date of the last disease progression/relapse observed in the treated patients. Any change to this definition during the study, for whatever reason, must be notified as a substantial amendment.
    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 months1
    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 months1
    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.1.2.1Number of subjects for this age range: 74
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 74
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 74
    F.4.2.2In the whole clinical trial 74
    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 particular post-trial treatments
    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 Decision2014-10-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-22
    P. End of Trial
    P.End of Trial StatusOngoing
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