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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   42168   clinical trials with a EudraCT protocol, of which   6935   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2015-003610-25
    Sponsor's Protocol Code Number:CT-MT001-2-2015-1
    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:2015-10-05
    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 number2015-003610-25
    A.3Full title of the trial
    A randomised, double-blind, placebo-controlled, parallel-design, multi-centre study to investigate the efficacy to reduce chemotherapy-induced neutropenia (CIN), effects on the haematopoietic system, safety and pharmacokinetics of Myelo001 in patients receiving adjuvant or neoadjuvant chemotherapy for the treatment of breast cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A test in female patients with breast cancer to probably reduce side effects on blood cells by the planned chemotherapy and to collect data for medical research and drug development on the safety, possible benefits and distribution of an experimental drug called Myelo001 in comparison to a standard treatment.
    A.3.2Name or abbreviated title of the trial where available
    MyeloConcept
    A.4.1Sponsor's protocol code numberCT-MT001-2-2015-1
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02692742
    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 SponsorMyelo Therapeutics GmbH
    B.1.3.4CountryGermany
    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 supportMyelo Therapeutics GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMyelo Therapeutics GmbH
    B.5.2Functional name of contact pointProject Management
    B.5.3 Address:
    B.5.3.1Street AddressGrossenhainer Strasse 227
    B.5.3.2Town/ cityDresden
    B.5.3.3Post code01129
    B.5.3.4CountryGermany
    B.5.4Telephone number+4935121927312
    B.5.5Fax number+4935121925493
    B.5.6E-mailclinicaltrials@myelotherapeutics.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 Yes
    D.2.1.1.1Trade name Dicarbamine
    D.2.1.1.2Name of the Marketing Authorisation holderОАО Valenta Pharmatsevtika
    D.2.1.2Country which granted the Marketing AuthorisationRussian Federation
    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 nameMyelo001
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNImidazolyl ethanamide pentandioic acid
    D.3.9.3Other descriptive nameVITAGLUTAM
    D.3.9.4EV Substance CodeSUB179202
    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) 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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chemotherapy-induced neutropenia (CIN)
    E.1.1.1Medical condition in easily understood language
    Decrease in white blood cells, particularly so called neutrophils, responsible for the human defense against bacterial infections due to cancer treatment.
    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 10072806
    E.1.2Term Chemotherapy toxicity attenuation
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of repeated doses of Myelo001 100 mg tablets
    taken once per day (QD) per os (p.o.) to reduce chemotherapy induced
    neutropenia (CIN) in patients receiving chemotherapy for the
    treatment of breast cancer
    E.2.2Secondary objectives of the trial
    To investigate:
    Efficacy to reduce chemotherapy-induced myelosuppression
    White blood cell (WBC) population changes
    Pharmacokinetics (PK) of Myelo001
    Safety parameters
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    To investigate:
    1.) Pharmacokinetics (PK) of Myelo001
    2.) Surrogate, correlative and predictive markers for hematologic changes due to Myelo001
    E.3Principal inclusion criteria
    Eligible patients must meet ALL of the following inclusion criteria:
    1. Female patient of any racial origin having fulfilled her 18th birthday on Visit 1 (Screening)
    2. Histologically confirmed invasive breast cancer scheduled for neoadjuvant CTX or adjuvant CTX (patient with primary wound healing ([R0])
    3. Already selected for neoadjuvant or adjuvant standard of care poly-chemotherapy regimen containing anthracyclines in combination with cyclophosphamide (with or without follow-up treatment with taxanes) defined as EC standard regimen
    4. Risk of CTX induced FN ≤20% according to ASCO guidelines (2015)
    5. More than 5 days remaining before the planned initiation of the 1st CTX cycle (d1/c1) to allow initiation of IMP on d-5/c1
    6. Performance status Grade 0-1 (ECOG)
    7. Echocardiography: No contraindication for the scheduled CTX
    8. Haematologic and chemistry thresholds at baseline:
    • Absolute neutrophil count (ANC) ≥2,000 cells/ mm3 (≥2.0 x 10^9/L)
    • Platelet count ≥100,000/mm3 (≥100 x 10^9/L)
    • Haemoglobin ≥10 g/dL
    • Total bilirubin <1.5 x, AST, ALT <2.5 x upper limit of normal (ULN)
    • Serum creatinine <2.0 mg/dL
    9. Able to read, understand and willing to sign the informed consent form
    10. Able to undergo the investigations and to follow the Visit schedule
    E.4Principal exclusion criteria
    A patient will be excluded from participation in the trial, if one or more of the following exclusion criteria are identified:
    1. Suspected allergy to Myelo001 or its excipients
    2. Prior chemotherapy
    3. Prior or concomitant treatment with radiotherapy
    4. Currently on or scheduled for other immunomodulatory or immunosuppressive therapies (e.g. TNF inhibitors) for the first CTX cycle
    5. Currently on or scheduled for other immunostimulatory or hematopoietic active therapies (e.g.G-CSF, GM-CSF) for the first CTX cycle
    6. Currently on or scheduled for primary prophylaxis with antibiotics for the first CTX cycle
    7. History of bone marrow transplantation or stem cell transplant
    8. Administration of another IMP / medical device within 30 days prior to screening. Participation in non-interventional, national or international cancer registries is allowed
    9. Already confirmed HIV, HBV or HCV infection
    10. History of somatic disease/condition that may interfere with the
    objectives of the study
    11. Any other medical disease or clinical laboratory parameter outside the normal range and of clinical significance according to the investigator
    12. Serious uncontrolled comorbidities
    13. Pregnant or breast-feeding subject
    14. Woman considered to be of childbearing potential who do not use highly effective birth control methods during the study
    E.5 End points
    E.5.1Primary end point(s)
    Primary variables (Proof of Concept):

    1 Primary endpoint: Threshold area over the curve (AOC) of ANC: Area below the threshold line (ANC 2.0x10^9/L classified as grade 1 neutropenia) and above the individual ANC trajectory, in the study period of d1/c1 to d22/c1

    2 Co-primary endpoint:
    Threshold area over the curve (AOC3) of ANC: Area below the threshold line (ANC 1.0x10^9/L classified as grade 3 neutropenia) and above the individual ANC trajectory, in the study period of d1/c1 to d22/c1

    3 Co-primary endpoint:
    Duration of ANC < 1.0x10^9/L classified as grade 3 neutropenia in the study period of d1/c1 to d22/c1
    E.5.1.1Timepoint(s) of evaluation of this end point
    Frequent blood counts in the study period between day1/cycle1 to day22/cycle1
    E.5.2Secondary end point(s)
    1 Secondary variables Treatment success rate will fulfill all of the following criteria:
    a) Neutropenia Grade ≤ 3
    b) No need for G-CSF / GM-CSF rescue therapy
    c) No early withdrawal (drop-out)
    Evaluation: d1/c1 to d22/c1 or drop-out or until one day post administration of rescue medication, whichever occurs first. Treatment failures are subjects not reaching any of the three criteria
    2 Threshold AOC of ANC: Area below the threshold line (ANC 0.5x10^9/L classified as grade 4 neutropenia) and above the individual ANC trajectory during study period of d1/c1 to d22/c1
    3 Threshold AOC of lymphocytes: Area below the threshold line (classified as grade 1) and above the individual absolute lymphocyte count trajectory during study period of d1/c1-d22/c1
    4 Threshold AOC of leukopenia: Area below the threshold line (classified as grade 1) and above the individual absolute leukocyte count trajectory during the study period of d1/c1 to d22/c1
    5 Threshold AOC of thrombocytes: Area below the threshold line (classified as grade 1) and above the individual absolute thrombocyte count trajectory during study period d1/c1 to d22/c1
    6 Rate of neutropenia grade 1 and higher; 3 and higher, 4, and ANC ≤0.1x 10^9/L
    7 Duration of neutropenia grade 1 and higher; 3 and higher, 4, and ANC ≤0.1x 10^9/L
    8 ANC at nadir
    9 Time to ANC nadir (from start of chemotherapy)
    10 Time to ANC recovery from grade 3 neutropenia, i. e. time from onset to time of reaching neutropenia grade ≤2 (ANC ≥ 1.5x10^9/L)
    11 Time to ANC recovery from grade 4 neutropenia, i. e. time from onset to time of reaching neutropenia grade ≤2 (ANC ≥ 1.5x10^9/L)
    12 Time to ANC recovery from profound neutropenia (ANC ≥ 0.1x10^9/L), i. e. time from onset to time of reaching neutropenia grade ≤2 (ANC ≥ 1.5x10^9/L)
    13 Rate of patients with rescue therapy during study period d1/c1 to d22/c1
    14 Rate of patients developing febrile neutropenia (body temperature ≥38.3°C by single tympanic or oral measurement) and ANC ≤0.5x 10^9/L (Grade 4) during study period d1/c1 to d22/c1
    15 Rate of patients with CTX dose reduction and/or delay of CTX cycle 2

    E.5.2.1Timepoint(s) of evaluation of this end point
    Various timepoints:
    In the study period of d1/c1 to d22/c1
    During entire study until EOS
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    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 Yes
    E.6.11Pharmacogenomic Yes
    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 Yes
    E.8.1.7.1Other trial design description
    multi-centre
    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 concerned24
    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 years1
    E.8.9.1In the Member State concerned months8
    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: 110
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state130
    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. Continuation of standard medical care. However, the data and safety monitoring board (DSMB) may decide for a longer follow-up of patients if "non-unresolved" adverse events persist.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Arbeitsgemeinschaft Gynäkologische Onkologie e.V. (AGO-B) - Sektion Brusterkrankungen
    G.4.3.4Network Country Germany
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation CESAR Central European Society for Anticancer Drug Research – EWIV
    G.4.3.4Network Country Austria
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-12-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-11-20
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