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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2007-000394-36
    Sponsor's Protocol Code Number:GCF071
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-05-15
    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 ConcernedUK - MHRA
    A.2EudraCT number2007-000394-36
    A.3Full title of the trial
    A Phase III randomised, multicentre, double-blind, therapeutic equivalence study of biosimilar G-CSF (PLIVA/Mayne filgrastim) versus Neupogen (filgrastim-Amgen) in subjects receiving doxorubicin and docetaxel as a combination chemotherapy for breast cancer
    A.4.1Sponsor's protocol code numberGCF071
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorHospira UK Ltd
    B.1.3.4CountryUnited Kingdom
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameGranulocyte-colony stimulating factor (G-CSF)PLIVA/Mayne filgrastim
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNfilgrastim
    D.3.9.2Current sponsor codePLD-108
    D.3.9.3Other descriptive namer-met HuG-CSF; GCSF; rG-CSF, PLIVA/Mayne filgrastim
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number240
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 typeRecombinant form of human G-CSF produced by r-DNA technology
    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 NEUPOGEN® Singleject 48 MU (0.96mg/ml)
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen
    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 nameNEUPOGEN® Singleject 48 MU (0.96mg/ml)
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNfilgrastim
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number240
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 typeRecombinant form of human G-CSF produced by r-DNA technology
    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
    This study is designed to demonstrate the therapeutic equivalence of PLIVA/Mayne filgrastim and Neupogen for the reduction in duration of neutropenia and the incidence of febrile neutropenia, in subjects receiving chemotherapy.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10029354
    E.1.2Term Neutropenia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the therapeutic equivalence of PLIVA/Mayne filgrastim to Neupogen.
    E.2.2Secondary objectives of the trial
    To compare the efficacy, safety and tolerability of PLIVA/Mayne filgrastim and Neupogen.
    To compare the immunogenicity of PLIVA/Mayne filgrastim and Neupogen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Females ≥18 and ≤70 years of age;
    2. Written Informed consent given;
    3. Subjects with invasive breast cancer appropriate for treatment with doxorubicin and docetaxel combination therapy in the neo-adjuvant, adjuvant or first line metastatic treatment setting, who have not previously received treatment with anthracyclines or taxanes;
    4. Any acute adverse effects of prior therapy must have resolved to ≤ NCI CTCAE (Version 3.0) grade 1 (excluding alopecia) prior to Day 1 of Cycle 1;
    5. ECOG Performance Status 0 or 1 as determined on Day 1 of Cycle 1 prior to administration of chemotherapy;
    6. Adequate bone marrow function, as determined within 1 day prior to administration of chemotherapy on Day 1 of Cycle 1 and as indicated by:
    * Hb≥10 g/dL (transfusion permitted)
    * Absolute neutrophil count (ANC) ≥1.5 x 10 9/L (10 to the power of 9/L)
    * Platelets ≥100 x 10 9/L (10 to the power of 9/L);
    7. Adequate renal and hepatic function, as determined within 1 day prior to administration of chemotherapy on Day 1 of Cycle 1 and as indicated by:
    * Creatinine <1.5 x ULN
    * Total bilirubin within normal reference range (unless elevation is known to be due to Gilbert's disease)
    * Subjects must also meet one of the following criteria:
    a) Alkaline phosphatase within normal reference range and both AST and ALT >2.5 x ULN; or
    b) Alkaline phosphatase <2.5 x ULN and both AST and ALT <1.5 x ULN; or
    c) Alkaline phosphatase <5 x ULN and both AST and ALT within normal reference range;
    8. Female subjects with reproductive potential must have a negative urine pregnancy test within 3 days prior to the first dose of chemotherapy (Day 1 of Cycle 1) and must agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months after discontinuation of treatment. Acceptable methods of contraception include IUD, oral contraceptive, subdermal implant and double barrier (condom with a contraceptive sponge or contraceptive suppository);
    9. Estimated life-expectancy >6 months.
    E.4Principal exclusion criteria
    1. Chemotherapy within the 4 weeks prior to the first dose of chemotherapy (Day 1 of Cycle 1) (or a longer period depending on the defined characteristics of the agents used e.g., 6 weeks for mitomycin);
    2. Radiotherapy within the 6 weeks prior to the first dose of chemotherapy, except for localised spot radiotherapy for bone metastases (Day 1 of Cycle 1) or any prior radiotherapy to the mediastinal/pericardial region;
    3. Any prior radiotherapy to the mediastinal/pericardial region;
    4. Any concurrent anti-cancer therapy, including endocrine therapy (with the exception of corticosteroids), immunotherapy and monoclonal antibody therapy. Concurrent treatment with bisphosphonates is also excluded unless the subject has been on a stable dose for four weeks prior to the first dose of chemotherapy (Day 1 of Cycle 1);
    5.Receipt of a non-registered, investigational agent as part of a clinical trial within 3 months prior to the first dose of chemotherapy (Day 1 of Cycle 1);
    6.Receipt of a registered agent as part of a clinical trial if final study follow-up visit is within 30 days of start of chemotherapy (Day 1 of Cycle 1);
    7.Prior bone marrow or stem cell transplant;
    8.Any known myeloid abnormality (to include a pre-malignant myeloid condition or malignant condition);
    9.Subjects who, in the Investigator’s opinion, have had extensive prior radiotherapy to a significant area of the bone marrow potentially affecting myelopoiesis;
    10.Co-existing active infection, or received systemic anti-infectives for the treatment of infection within 72 hours prior to the first dose of chemotherapy (Day 1 of Cycle 1);
    11.Significant cardiovascular disease as defined by:
    a.History of congestive heart failure requiring therapy;
    b.History of unstable angina pectoris or myocardial infarction within 6 months prior to screening;
    c.Presence of severe valvular heart disease;
    d.Presence of an arrhythmia requiring treatment;
    12.Any co-existing medical condition that in the Investigator’s judgement will substantially increase the risk associated with the subject’s participation in the study;
    13.Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary procedures;
    14.Clinically symptomatic brain metastases (baseline computerized tomography (CT) or magnetic resonance imaging (MRI) scan of the brain required only if there is clinical suspicion of central nervous system metastases);
    15.Known hypersensitivity to E. coli-delivered products or docetaxel or other drugs formulated with polysorbate 80;
    16.Previously received any G-CSF;
    17.Uncontrolled hypercalcaemia (>NCI CTCAE (Version 3.0) grade 1);
    18.Second malignancy (except adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix);
    19.Pregnant or breast-feeding women;
    20.Concomitant treatment with lithium or lithium products;
    21. Hereditary fructose intolerance;
    22. Concurrent treatment with erythropoietin or prior treatment within 4 weeks prior to the first dose of chemotherapy (Day 1 of Cycle 1).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is DSN (in days) (ANC <0.5 x 10 9/L (10 to the power of 9/L) and body temperature of >38.5°C.
    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 Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    E.8.2.3.1Comparator description
    Neupogen®
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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 months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 279
    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 Decision2007-05-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-09-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-09-30
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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