Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   35654   clinical trials with a EudraCT protocol, of which   5853   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).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2011-002678-21
    Sponsor's Protocol Code Number:APO-Peg-03
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-11-24
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2011-002678-21
    A.3Full title of the trial
    A PHASE III, RANDOMIZED, ACTIVE CONTROLLED, ASSESSORBLINDED
    STUDY OF SAFETY AND EFFICACY OF PEGYLATED APOFILGRASTIM VERSUS US AND EU LICENSED NEULASTA® IN SUBJECTS WITH STAGE IIA, IIB OR IIIA BREAST CANCER RECEIVING TAC ANTICANCER CHEMOTHERAPY IN ADJUVANT SETTING
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    STUDY OF SAFETY AND EFFICACY OF PEGYLATED APOFILGRASTIM VERSUS US AND EU LICENSED NEULASTA® IN PATIENTS WITH BREAST CANCER
    A.4.1Sponsor's protocol code numberAPO-Peg-03
    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 SponsorApotex Inc
    B.1.3.4CountryCanada
    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 supportApotex Inc
    B.4.2CountryCanada
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAccelsiors CRO and Consultancy Services
    B.5.2Functional name of contact pointClinical Trials Info
    B.5.3 Address:
    B.5.3.1Street Address50 Miskolci Ut
    B.5.3.2Town/ cityBudapest
    B.5.3.3Post code1147
    B.5.3.4CountryHungary
    B.5.4Telephone number+3612990091
    B.5.5Fax number+3612990096
    B.5.6E-mailclinicaltrials@accelsiors.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 namePegylated Apo-Filgrastim
    D.3.2Product code Pegylated Apo-Filgrastim
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 codePegylated Apo-Filgrastim
    D.3.9.3Other descriptive nameGranulocyte Colony Stimulating Factors
    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 number10
    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 No
    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 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.3.4Pharmaceutical 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/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 No
    D.IMP: 3
    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 Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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.3.4Pharmaceutical 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/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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
    Febrile neutropenia in breast cancer patients undergoing TAC chemotherapy
    E.1.1.1Medical condition in easily understood language
    Low white blood cell counts in breast cancer patients undergoing chemotherapy
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10016288
    E.1.2Term Febrile neutropenia
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    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 an equivalent efficacy of Pegylated Apo‐Filgrastim as
    compared to each of the commercially available US and EU licensed
    Neulasta® in patients suffering from early breast cancer and receiving TAC
    (docetaxel, doxorubicin, cyclophosphamide) anticancer chemotherapy in
    adjuvant setting.
    E.2.2Secondary objectives of the trial
    • To assess the safety of Pegylated Apo‐Filgrastim as compared to that
    of commercially available US and EU licensed Neulasta® when administered through 6 cycles of TAC anticancer chemotherapy
    • To assess the potential antigenicity of Pegylated Apo‐Filgrastim during the chemotherapy and 30 weeks after the completion of chemotherapy
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female, ≥18 of age, suitable and intended to undergo adjuvant TAC (docetaxel, doxorubicin, cyclophosphamide) chemotherapy.
    2. Body weight within 40 and 120 kg
    3. Subjects within 60 days of complete surgical resection of the primary breast tumor: either lumpectomy or mastectomy with sentinel lymph node biopsy or axillary dissection, with clear margins for both invasive and ductal carcinoma in situ (DCIS)
    4. Stage IIA, IIB or IIIA breast cancer
    5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
    6. Absolute neutrophil count (ANC) ≥1,5 x 109/L; platelet count ≥100 x 109/L
    7. Adequate renal (serum creatinine <1,5 x upper limit of normal (ULN)) and hepatic function (bilirubin < ULN, transaminases and alkaline phosphatase (AP) <1,5 x ULN)
    8. Normal cardiac function evidenced by a left ventricle ejection fraction (LVEF) ≥55%
    9. No evidence of metastatic disease
    10. Baseline bilateral mammography (or other scan to exclude cancer on the contralateral breast)
    11. Subjects must not intend to conceive during or shortly after the study. They must be either post‐menopausal, surgically incapable of bearing children, or practicing an acceptable method of birth control (e.g., hormonal contraceptives, intrauterine device, or spermicide and barrier) and be willing to continue the same method of birth control during the entire course of the study
    12. Females of child‐bearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test before the first dose of study medication
    13. Willing and able to give written informed consent
    14. Willing and able to undergo procedures required by this protocol.
    E.4Principal exclusion criteria
    1. Bilateral breast cancer (concomitant or prior) except in situ lesion, either ductal or lobular, of the contralateral breast
    2. History of severe hypersensitivity reaction to medications intended to use in this protocol
    3. Prior chemotherapy (either adjuvant or neoadjuvant) for this breast cancer
    4. History of myocardial infarction, heart failure, uncontrolled angina, severe uncontrolled arrhythmias, pericardial disease, or electrocardiographic evidence of acute ischemic changes
    5. Immunotherapy, hormonal therapy (e.g. tamoxifen or aromatase inhibitors), Herceptin (trastuzumab) concurrently or within 30 days of screening
    6. Concurrent radiation therapy
    7. Investigational therapy concurrently or within 30 days of screening
    8. Peripheral neuropathy >Grade 1
    9. Major organ allograft or condition requiring chronic immunosuppression (i.e. kidney, liver, lung, heart, bone marrow transplant, or autoimmune diseases). Patients who received corneal transplants or cadaver skin or bone transplants are eligible.
    10. Serious uncontrolled intercurrent medical or psychiatric illness, including serious viral (including clinically defined acquired immunodeficiency syndrome ‐ AIDS), bacterial or fungal infection; or history of uncontrolled seizures, or diabetes, or central nervous system disorders deemed by the Investigator to be clinically
    significant, precluding informed consent
    11. Active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is known to be HIV positive
    12. History of other malignancy within the last 5 years (except cured basal cell carcinoma of skin, carcinoma in situ of uterine cervix or DCIS)
    13. Pregnancy or breastfeeding.
    E.5 End points
    E.5.1Primary end point(s)
    Duration of severe neutropenia (DSN) in cycle 1. Severe neutropenia is
    defined as occurrence of ANC below 0,5 x 109/L.
    E.5.1.1Timepoint(s) of evaluation of this end point
    D0,D1,D3,D5,D6,D8 and D10-15
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints:
    • The frequency of grade 3 and 4 severe neutropenia (ANC below 1,0 x
    109/L and 0,5 x 109/L, respectively)
    • The depth of ANC nadir in cycles 1
    • The time to the post nadir ANC recovery (ANC ≥2,0 X 109) in cycle 1
    • The rates of Febrile Neutropenia (FN) by cycle and across the cycles.
    The definition of FN used for the purpose of this protocol will be,
    single temperature: ≥38,3°C measured orally or ≥38,0°C for over 1
    hour; neutropenia: ANC <0,5 X 109/L or <1 X 109/L and a predicted
    decline to ≤0,5 X 109/L over the next 48 hours.
    • The ANC‐time profile in cycle 1 (The time from the beginning of
    chemotherapy to the occurrence of the ANC nadir)
    • The frequency and type of (culture‐confirmed) infections
    • The incidence of i.v. antibiotic therapy and hospitalization
    • The mobilization of CD34+ cells (in selected centers only)
    • Incidence, severity and distribution of bone pain
    • Percentage of scheduled chemotherapy dose that was delivered
    • Proportion with chemotherapy doses reduced, omitted, or delayed
    • Number of days of delay of chemotherapy
    • Occurrence and/or resolution of chemotherapy‐induced mucositis
    Safety endpoints
    • Incidence of adverse events (all severe and serious) classified by
    system organ class, preferred term, severity, and relationship to
    study medication
    • Injection site reactions
    • Vital signs
    • Presence of antibodies and abnormal clinical laboratory results.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Cycle1: D0,D1,D2,D3,D5,D6,D7,D9 and D8, D10-15
    Cycle 2-6:D1,D2,D9±1, W20,W24,W36 and W48
    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 Yes
    E.8.1.4Double blind No
    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 trial3
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA67
    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
    Bosnia and Herzegovina
    Bulgaria
    Czech Republic
    Egypt
    Georgia
    Hungary
    Morocco
    Poland
    Romania
    Russian Federation
    Serbia
    Slovakia
    Tunisia
    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
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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: 545
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 55
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 225
    F.4.2.2In the whole clinical trial 600
    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 Decision2012-01-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-05-30
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2019 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA