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    Summary
    EudraCT Number:2011-004532-58
    Sponsor's Protocol Code Number:LA-EP06-301
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-05-22
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2011-004532-58
    A.3Full title of the trial
    A randomized, double-blind, parallel-group, multi-center Phase 3 comparative study investigating efficacy and safety of LA-EP2006 and Neulasta® in breast cancer patients treated with myelosuppressive chemotherapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study comparing the efficacy and safety of LA-EP2006 and Neulasta in breast cancer patients being treated with types of chemotherapy which decrease white blood cells.
    A.4.1Sponsor's protocol code numberLA-EP06-301
    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 SponsorSandoz GmbH
    B.1.3.4CountryAustria
    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 supportSandoz GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSandoz GmbH
    B.5.2Functional name of contact pointClinical Development Manager
    B.5.3 Address:
    B.5.3.1Street AddressIndustriestrasse 25
    B.5.3.2Town/ cityHolzkirchen
    B.5.3.3Post code83607
    B.5.3.4CountryGermany
    B.5.4Telephone number004980244762950
    B.5.5Fax number004980244762979
    B.5.6E-mailstefan.kramer@sandoz.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 nameLA-EP2006
    D.3.2Product code LA-EP2006
    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 codeLA-EP2006
    D.3.9.4EV Substance CodeSUB16451MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6 mg/0.6 ml
    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 typePegfilgrastim is a covalent conjugate of recombinant methionyl human granulocyte-colony stimulating factor and polyethylene glycol.
    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®
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V
    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 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.3.9.3Other descriptive nameNeulasta
    D.3.9.4EV Substance CodeSUB16451MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6 mg/0.6 ml
    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 typePegfilgrastim is a covalent conjugate of recombinant methionyl human granulocyte-colony stimulating factor and polyethylene glycol.
    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
    Breast Cancer
    E.1.1.1Medical condition in easily understood language
    Breast Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10006203
    E.1.2Term Breast cancer stage unspecified
    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 assess the efficacy of LA-EP2006 compared to Neulasta® with respect to the mean duration of severe neutropenia (DSN), defined as number of consecutive days with Grade 4 neutropenia (absolute neutrophil count [ANC] less than 0.5 x 10 9/L), during Cycle 1 of the neoadjuvant or adjuvant TAC regimen (Taxotere® [docetaxel 75 mg/m2] in combination with Adriamycin® [doxorubicin 50 mg/m2] and Cytoxan® [cyclophosphamide 500 mg/m2]) in breast cancer patients.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to further compare LA-EP2006 and Neulasta® with respect to the efficacy, safety, and immunogenicity of both products.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The patients must fulfill all of the following criteria to be eligible for admission to the study:
    •Written informed consent before any assessment is performed
    •Patients with histologically proven breast cancer, eligible for neoadjuvant or adjuvant TAC chemotherapy
    •Women ≥ 18 years of age
    •Estimated life expectancy of more than six months
    •Eastern cooperative oncology group (ECOG) performance status ≤ 2
    •Adequate bone marrow function on Cycle 1 Day 1 prior to chemotherapy administration:
    •ANC ≥ 1.5 x 10 9/L
    •Platelet count ≥ 100 x 10 9/L
    •Hemoglobin ≥ 10 g/dL
    •Total bilirubin not higher than the upper limit of normal (ULN), unless the patient has Gilbert`s syndrome
    •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) level ≤ 2 x ULN
    •Liver-derived alkaline phosphatase level ≤ 3 x ULN
    •Creatinine ≤ 1.5 x ULN
    •For all women of childbearing potential: negative serum pregnancy test within seven days prior to randomization, and using a highly effective method of birth control
    E.4Principal exclusion criteria
    The patients meeting any of the following exclusion criteria will not be enrolled in the study:
    1. History of chronic myeloid leukemia or myelodysplastic syndrome
    2. History or presence of sickle cell disease
    3. Previous or concurrent malignancy except non-invasive non-melanomatous skin cancer, in situ carcinoma of the cervix, or other solid tumor treated curatively, and without evidence of recurrence for at least ten years prior to study entry
    4. Any serious illness or medical condition that may interfere with safety, compliance, response to the products under investigation or chemotherapy and their evaluation such as:
    • Active uncontrolled infection
    • Clinically significant impairment of left ventricular ejection fraction
    (LVEF measured within three month before study entry by
    echocardiography or multiple-gated acquisition scan (MUGA) must be above the lower limit of normal for the respective center)
    • Severe valvular heart disease, myocardial infarction, unstable angina pectoris, uncontrolled hypertension or uncontrolled arrhythmias within six months from study entry
    • Significant neurologic or psychiatric disorders including psychotic
    disorders, dementia or seizures that would prohibit the understanding and giving of informed consent
    5. Concurrent or prior radiotherapy within four weeks of randomization
    6. Concurrent or prior chemotherapy for breast cancer
    7. Concurrent or prior anti-cancer treatment for breast cancer such as endocrine therapy, immunotherapy, monoclonal antibodies and/or biological therapy
    8. Concurrent prophylactic antibiotics
    9. Prior bone marrow or stem cell transplant
    10. Previous therapy with any rhG-CSF product
    11. Known hypersensitivity to E. coli proteins or any of the excipients used in the IMPs
    12. Patient known to have HIV, Hepatitis B, Hepatitis C infection or who have positive serology for HIV, Hepatitis B or Hepatitis C at screening
    13. Known active drug addiction, including alcoholism
    14. Participation in any other clinical study using an IMP or device within three months before the screening visit.
    E.5 End points
    E.5.1Primary end point(s)
    • Mean duration of Grade 4 neutropenia, defined as the number of consecutive days in which the patient had an ANC < 0.5 × 10 9/L during Cycle 1 of chemotherapy
    E.5.1.1Timepoint(s) of evaluation of this end point
    • Mean duration of Grade 4 neutropenia, defined as the number of consecutive days in which the patient had an ANC <0.5 x 10 9/L during Cycle 1 of chemotherapy
    E.5.2Secondary end point(s)
    • Incidence of febrile neutropenia (FN), defined as oral temperature ≥ 38.3 °C while having an ANC < 0.5 x 10 9/L (both measured on the same day) by cycle and across all cycles
    • Number of days of fever, defined as oral temperature ≥ 38.3 °C, for each cycle
    • Depth of ANC nadir, defined as the patient`s lowest ANC in Cycle 1
    • Time to ANC recovery, defined as the time in days from the chemotherapy administration until the patient`s ANC increased to ≥ 2 x 10 9/L after the nadir, in Cycle 1
    • Frequency of infection by cycle and across all cycles
    • Mortality due to infection
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Incidence of febrile neutropenia (FN), defined as oral temperature ≥ 38.3 °C while having an ANC < 0.5 x 10 9/L (both measured on the same day) by cycle and across all cycles
    • Number of days of fever, defined as oral temperature ≥ 38.3 °C, for each cycle
    • Depth of ANC nadir, defined as the patient`s lowest ANC in Cycle 1
    • Time to ANC recovery, defined as the time in days from the chemotherapy administration until the patient`s ANC increased to ≥ 2 x 10 9/L after the nadir, in Cycle 1
    • Frequency of infection by cycle and across all cycles
    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 Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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
    Brazil
    Bulgaria
    India
    Mexico
    Poland
    Romania
    Russian Federation
    Turkey
    Ukraine
    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
    Last Visit Last Subject
    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 months4
    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 months4
    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: 302
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 243
    F.4.2.2In the whole clinical trial 302
    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)
    Subjects will return to standard of care treatment once participation has ended.
    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 Decision2012-08-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-02-07
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