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    Summary
    EudraCT Number:2014-002448-42
    Sponsor's Protocol Code Number:GMI-1271-201
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-11-06
    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 ConcernedIreland - HPRA
    A.2EudraCT number2014-002448-42
    A.3Full title of the trial
    A Phase I/II, open-label multicenter study to determine safety, pharmacokinetics and efficacy of GMI-1271 in combination with chemotherapy in patients with acute myeloid leukemia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to determine the safety, pharmacokinetics and efficacy of GMI-1271 when given at the same time as anti-cancer drugs in patients with a rare type of cancer called acute myeloid leukemia.
    A.4.1Sponsor's protocol code numberGMI-1271-201
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02306291
    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 SponsorGlycoMimetics, Inc.
    B.1.3.4CountryUnited States
    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 supportGlycoMimetics Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlycoMimetics Inc.
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street Address9708 Medical Center Drive
    B.5.3.2Town/ cityRockville
    B.5.3.3Post codeMD 20850
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@glycomimetics.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.3.2Product code GMI-1271
    D.3.4Pharmaceutical form 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.3.9.1CAS number 1914993-95-5
    D.3.9.2Current sponsor codeGMI-1271
    D.3.9.3Other descriptive nameSODIUM (1R, 3R, 4R, 5S)-3-({2-N-ACETYLAMINO-2-DEOXY-3-O-[(1S)-1-CARBOXYLATO-2-CYCLOHEXYLETHYL]-Β-D-GALACTOPYRANOSYL}OXY)-4-({6-DEOXY-Α-LGALACTOPYRANOSYL}OXY)-5-ETHYL-CYCLOHEXAN-1-YL-(38-OXO-2,5,8,11,14,17,20,23,26,29,32,35-DODECAOXA-39-AZAHENTETRACONTAN-41-YL) CARBOXAMIDE
    D.3.9.4EV Substance CodeSUB169194
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Acute myeloid leukemia
    E.1.1.1Medical condition in easily understood language
    A blood cancer called Acute Myeloid Leukemia
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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
    To evaluate the safety of GMI-1271 in combination with chemotherapy
    E.2.2Secondary objectives of the trial
    •Characterize the PK profile of GMI-1271
    •Evaluate efficacy of GMI-1271 in combination with chemotherapy (relapsed/refractory subjects: MEC; treatment-naïve subjects: “7+3” cytarabine/ idarubicin) as measured by overall response rate
    •Time to response
    •Evaluate duration of response
    •Evaluate the event-free survival
    •Evaluate 6-month and 12- month overall survival probability
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Signed informed consent form (ICF)
    2.AML (including secondary AML) diagnosed as per World Health Organization (WHO) criteria (Brunning RD 2001) as per local analysis report.
    3.For relapsed/refractory subjects only:
    a) Subjects age ≥ 18 years
    b) For subjects with primary refractory AML, ≤ 2 prior induction regimens, at least one containing anthracyclines
    c) For subjects with relapsed AML, first or second untreated relapse. Secondary refractory disease (e.g. refractory after first or second relapse) may not be included. Subjects with one prior HSCT may be included. Any cytotoxic induction regimen used with the intent to induce remission, regardless of the agents used, will be counted as an induction attempt towards this assessment. Single agent FLT3 inhibitors are not considered cytotoxic chemotherapy for the purposes of this
    assessment.
    d) Have not previously received MEC and are medically eligible to receive MEC
    e) Absolute blast count (ABC) ≤ 20,000/mm3 (ABC = total white blood cells [WBC] x blast %)
    • Entry ABC will be raised to ≤ 40,000/mm3 after evaluation of first two dose levels
    4.For treatment-naïve subjects only:
    a) Subjects ≥ 60 years of age with newly diagnosed AML
    b) Medically eligible to receive “7+3” cytarabine/idarubicin
    c) Absolute blast count (ABC) count ≤ 40,000/mm3
    5.Eastern Cooperative Oncology Group (ECOG) performance status 0-2
    6.Life expectancy > 4 weeks
    7.Hemodynamically stable with adequate organ function
    a)AST and ALT ≤ 2.5 ULN
    b)Bilirubin ≤ 1.5 ULN
    c)Creatinine ≤ 1.5 ULN
    d)QTcF ≤ 480 ms
    8.Willing and able to participate in all required evaluations and procedures in this study protocol
    E.4Principal exclusion criteria
    1.Acute promyelocytic leukemia
    2.Acute leukemia of ambiguous lineage (biphenotypic leukemia)
    3.Active signs or symptoms of CNS involvement by malignancy (LP not required)
    4.Prior G-CSF, GM-CSF or plerixafor within 14 days of study drug dosing
    5.Known history or evidence of active hepatitis A, B, or C or HIV
    6.Uncontrolled acute life threatening bacterial, viral or fungal infection
    7.Active graft versus host disease (GVHD) ≥ Grade 2 or extensive chronic GVHD requiring immunosuppressive therapy
    8.HSCT ≤ 4 months of dosing
    9.Any immunotherapy, radiotherapy or experimental therapy within 4 weeks of dosing; any chemotherapy within 14 days of dosing, with the exception of: hydroxyurea, which may be used to control peripheral blast count prior to initiation of GMI-1271 dosing; and FLT3 inhibitors or TKI inhibitors, which are not considered cytotoxic chemotherapy; to avoid any drug-drug interaction such agents must be discontinued 5 days before protocol treatment begins.
    10.Major surgery within 4 weeks before first dose of study drug
    11.Significant cardiovascular disease
    12.Previous or concurrent malignancy
    13.Pregnant or nursing (lactating) women
    14.WOMEN of child-bearing potential unless they are using highly effective methods of contraception during the study
    15.MEN who are sexually active and not willing to use condoms during the duration of the study unless they have undergone vasectomy for sterilization
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is the frequency, severity, and relatedness of Adverse Events.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety will be assessed from baseline (Day -1) through to End of Treatment
    E.5.2Secondary end point(s)
    Pharmacokinetics: The PK data will be analyzed using Bayesian population methods.
    Interim PK analysis will be performed to evaluate PK parameters for individual dose levels.
    Secondary efficacy endpoints: Overall response rate (ORR) is defined as the proportion of subjects who achieve a Complete Response (CR) or Complete response with incomplete blood count recovery (CRi)
    Time to response (TTR): Time from date of first dose to first documentation of response (CR or CRi).
    Duration of response (DOR): Time (months) from date of first documented remission (CR or CRi) to the date of relapse or death from any cause, whichever occurs first.
    Event-free survival (EFS): Time (months) from date of first dose to the date of treatment failure, relapse, or death from any cause, whichever occurs first.
    Overall survival (OS):Time (months) from date of first dose to the date of death from any cause.
    6-month and 12- month OS probability: The probability of survival at 6 and 12-month, respectively, after the date of first dose based on the Kaplan-Meier estimate.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The endpoints will be measured at End of Treatment; Phase I (6 months) and Phase II (12 months)
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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
    Safety and pharmacokinetics in patients
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Ireland
    United States
    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 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.1.2.1Number of subjects for this age range: 53
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 49
    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 state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 13
    F.4.2.2In the whole clinical trial 102
    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)
    None
    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 Decision2014-12-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-05-15
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