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    Summary
    EudraCT Number:2014-002324-27
    Sponsor's Protocol Code Number:MYL-1401H-3001
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-03-20
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2014-002324-27
    A.3Full title of the trial
    Multicenter, Double-Blind, Randomized, Comparative Efficacy and Safety Study of MYL 1401H and European Sourced Neulasta® in Stage II/III Breast Cancer Patients Receiving Neoadjuvant or Adjuvant Chemotherapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This study will compare the efficacy of MYL-1401H versus Neulasta® for the treatment of chemotherapy-induced neutropenia (dangerously low levels of a type of white blood cells) in patients with stage II/III breast cancer receiving anti-cancer chemotherapy (docetaxel, doxorubicin, and cyclophosphamide)
    A.4.1Sponsor's protocol code numberMYL-1401H-3001
    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 SponsorMylan GmbH
    B.1.3.4CountrySwitzerland
    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 supportMylan GmBH
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMylan GmbH
    B.5.2Functional name of contact pointDr. Fausto Berti
    B.5.3 Address:
    B.5.3.1Street AddressThurgauerstrasse, 40
    B.5.3.2Town/ cityZurich
    B.5.3.3Post code8050
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+4144308 75 48
    B.5.6E-mailfausto.berti@mylan.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 nameMYL-1401H
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPEGFILGRASTIM
    D.3.9.1CAS number 208265-92-3
    D.3.9.2Current sponsor codeMYL-1401H
    D.3.9.4EV Substance CodeSUB16451MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeMYL-1401H is a human pegylated filgrastim produced by recombinant deoxyribonucleic acid (DNA) technology using E. coli.
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Neulasta® (pegfilgrastim)
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe BV
    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.3.1Product nameNeulasta®
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPEGFILGRASTIM
    D.3.9.1CAS number 208265-92-3
    D.3.9.4EV Substance CodeSUB16451MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeproduced by recombinant deoxyribonucleic acid (DNA) technology using E. coli. followed by conjugation with polyethylene glycol (PEG).
    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
    chemotherapy-induced neutropenia in patients with stage II/III breast cancer receiving docetaxel, doxorubicin, and cyclophosphamide (TAC) anti-cancer chemotherapy
    E.1.1.1Medical condition in easily understood language
    Having dangerously low white blood cells (Neutropenia) in patients as a result of taking chemotherapy drugs for breast cancer. This makes them susceptible to infections.
    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 18.0
    E.1.2Level PT
    E.1.2Classification code 10029354
    E.1.2Term Neutropenia
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10006187
    E.1.2Term Breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to compare the efficacy of MYL-1401H versus Neulasta® for the prophylactic treatment of chemotherapy-induced neutropenia in patients with stage II/III breast cancer receiving TAC anti-cancer chemotherapy.
    E.2.2Secondary objectives of the trial
    - To assess the safety of MYL-1401H and Neulasta® when administered through 6 cycles of TAC anti-cancer chemotherapy
    - To assess the potential immunogenicity of MYL-1401H and Neulasta® during chemotherapy and up to 24 weeks following the first administration
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed and dated written informed consent.
    2. Patients aged ≥ 18 years.
    3. Women of child-bearing potential must agree to use effective methods of birth control during the treatment period from the first dose of study drug until 6 months following the last dose of study drug. Acceptable methods of contraception include nonhormonal intrauterine device and barrier methods (male condom, female condom, diaphragm or cervical cap) with spermicide. Female patients who normally abstain from sexual activity may be recruited providing they remain abstinent during the study or if they become sexually active, they must agree to use effective methods of birth control as described above.
    4. Male patients without a vasectomy must agree to use a condom and their female partners of child-bearing potential must agree to use another form of contraception (hormonal contraceptives, intrauterine device, diaphragm with spermicide, or cervical cap with spermicide) during the treatment period from the first dose of study drug until 6 months following the last dose of study drug.
    5. Newly diagnosed, pathologically confirmed breast cancer.
    6. Stage II or III breast cancer with adequate staging workup (NCCN guidelines; Version 1.201413) and adequate surgery if receiving adjuvant therapy.
    7. Patients planned/eligible to receive neoadjuvant or adjuvant treatment with TAC for their breast cancer.
    8. Cancer Chemotherapy and Radiotherapy naïve.
    9. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
    10. Absolute neutrophil count ≥ 1.5 × 10 (9)/L.
    11. Platelet count ≥ 100 × 10 (9)/L.
    12. Hemoglobin > 10 g/dL without blood transfusions or cytokine support during the 2 weeks previous to the hemoglobin level.
    13. Adequate cardiac function (including left ventricular ejection fraction ≥ 50% as assessed by echocardiography) within 4 weeks prior to start of chemotherapy.
    14. Adequate renal function, i.e., creatinine < 1.5 × upper limit of normal (ULN).
    E.4Principal exclusion criteria
    1. Participation in a clinical trial in which they received an investigational drug within 28 days before randomization.
    2. Previous exposure to filgrastim, pegfilgrastim, lenograstim, lipegfilgrastim, or other filgrastims on the market or in clinical development.
    3. Received blood transfusions or erythroid growth factors within 2 weeks prior to first dose of chemotherapy.
    4. Known hypersensitivity to any drugs or excipients that patients will be receiving during the study.
    5. Known hypersensitivity to E. coli-derived products.
    6. Known fructose intolerance (related with sorbitol excipient).
    7. Underlying neuropathy of grade 2 or higher.
    8. Active infectious disease or any other medical condition which might put the patient at significant risk to tolerate 6 courses of TAC chemotherapy (e.g., recent myocardial infarction).
    9. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 × ULN, ALT and/or AST > 1.5 × ULN with alkaline phosphatase (ALP) > 2.5 × ULN; any bilirubin > ULN. Any alteration of liver function and/or ALP elevation, even within acceptance limits, should be investigated before randomization to exclude any stage IV disease.
    10. Treatment with systemically active antibiotics within 5 days before first dose of chemotherapy.
    11. Patients under treatment with lithium.
    12. Chronic use of oral corticosteroids.
    13. Splenomegaly of unknown origin by physical examination and/or computerized tomography scan or ultrasound and any condition which can cause splenomegaly, e.g., thalassemia, glandular fever, hemolytic anemias, and malaria.
    14. Myeloproliferative or myelodysplastic disorders, sickle cell disorders, and any illness or condition that in the opinion of the investigator may affect the safety of the patient or the evaluation of any study endpoint.
    15. Increase potential risk of Adult Respiratory Distress Syndrome.
    16. Pregnant or nursing women.
    17. Patients known to be seropositive for human immunodeficiency virus (HIV), or who have had an acquired immunodeficiency syndrome (AIDS) defining illness or a known immunodeficiency disorder.
    18. A known active abuse of drugs or alcohol should preclude patient participation and evaluation in the study.
    19. Any known psychiatric conditions.
    20. Any disease or physical condition that may not allow for the adequate performance of study assessments, such as lack of access to patient’s domiciliary, and distance of patient’s domiciliary from clinic site.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is the DSN in cycle 1, defined as days with ANC < 0.5 × 10 (9) /L.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Cycle 1
    E.5.2Secondary end point(s)
    Efficacy:
    • The frequency of the worst grade (grade 3 or 4) neutropenia by cycle and across all cycles
    • The depth of the ANC nadir in cycle 1
    • The time to the post-nadir ANC recovery in cycle 1
    • The ANC-time to nadir in cycle 1 (i.e., time from the beginning of chemotherapy to the occurrence of the ANC nadir)
    • The rate of Febrile Neutropenia (FN) defined by the ESMO Clinical Practice Guidelines with a single oral temperature > 38.5°C or 2 consecutive readings of an oral temperature > 38.0°C for 2 hours, by cycle and across all cycles
    • Percentage of scheduled chemotherapy doses that were delivered
    • Proportion of chemotherapy doses reduced, omitted, or delayed related to neutropenia, FN, or documented infections
    • Number of days of delay of chemotherapy related to neutropenia, FN, or documented infections

    Safety:
    • Incidence, nature, and severity of AEs including adverse drug reactions (ADRs)
    • Incidence, severity, and distribution of bone pain by BPI form (Short Form) in cycle 1 and cycle 2 only
    • Incidence, severity, and distribution of infections
    • Injection site tolerance
    • Incidence, titer, and neutralizing capacity of antibodies against MYL-1401H and Neulasta®
    E.5.2.1Timepoint(s) of evaluation of this end point
    throughout Cycles 1-6 as documented above
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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) Yes
    E.8.2.2Placebo No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Belarus
    Bulgaria
    Georgia
    Germany
    Hungary
    Mexico
    Poland
    Russian Federation
    Ukraine
    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
    LPLV
    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
    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: 189
    F.1.3Elderly (>=65 years) No
    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 state29
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 189
    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)
    Subsequent treatments of the study subject will be at the discretion of
    the investigator in accordance to standard care.
    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 Decision2015-05-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-02-09
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