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    Summary
    EudraCT Number:2013-003166-14
    Sponsor's Protocol Code Number:RGB-02-101
    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:2013-10-01
    Trial 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 number2013-003166-14
    A.3Full title of the trial
    Multiple, fixed-dose, comparative efficacy and safety evaluation of RGB-02 and Neulasta® in patients undergoing chemotherapy treatment known to induce neutropenia.
    Többszöri, fix dózist alkalmazó, összehasonlító jellegű klinikai vizsgálat az RGB-02 és a Neulasta® hatásosságának és biztonságosságának értékelésére ismerten neutropéniát indukáló kemoterápiás kezelésben részesülő betegeknél
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study designed to compare safety and efficacy of RGB-02 and Neulasta® in breast cancer patients receiving chemotherapy
    A.4.1Sponsor's protocol code numberRGB-02-101
    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 SponsorGedeon Richter Plc.
    B.1.3.4CountryHungary
    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 supportGedeon Richter Plc.
    B.4.2CountryHungary
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGedeon Richter Plc.
    B.5.2Functional name of contact pointHerta Pálfi Goóts
    B.5.3 Address:
    B.5.3.1Street AddressGyömrői út 19-21
    B.5.3.2Town/ cityBudapest
    B.5.3.3Post code1103
    B.5.3.4CountryHungary
    B.5.4Telephone number+3614314040
    B.5.5Fax number+3614315415
    B.5.6E-mailRA.ctaRichter@richter.hu
    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.3.2Product code RGB-02
    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 codeRGB-02
    D.3.9.3Other descriptive namePegylated human granulocyte colony stimulating factor
    D.3.9.4EV Substance CodeSUB16451MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number9.3 to 10.7
    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 B.V.
    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 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.3.9.3Other descriptive namePegylated human granulocyte colony stimulating factor
    D.3.9.4EV Substance CodeSUB16451MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number9.3 to 10.7
    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
    Neutropenia and febrile neutropenia in patients being treated with cytotoxic chemotherapy for malignancy.
    E.1.1.1Medical condition in easily understood language
    Neutropenia is a blood disorder in which the number of neutrophils (type of white blood cell) in the bloodstream is reduced. Neutropenia is often caused by drugs used to treat cancer.
    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 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 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 assess and compare the efficacy of RGB-02 versus Neulasta® in breast cancer patients receiving AT (docetaxel-doxorubicine) chemotherapy in adjuvant or neoadjuvant setting.
    E.2.2Secondary objectives of the trial
    To evaluate safety and immunogenicity of RGB-02 compared to Neulasta® and collect long term safety and immunogenicity data for RGB-02
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Females ≥ 18 and ≤ 65 years of age.
    2. Patients with invasive breast cancer (Stage IIB and III) appropriate for treatment with doxorubicin and docetaxel combination therapy in the neoadjuvant or adjuvant treatment setting.
    3. ECOG performance status 0 or 1.
    4. Chemotherapy naïve.
    5. Adequate bone marrow function assessed during Screening, as indicated by:
    a. ANC ≥ 1.5 x10^9/L,
    b. Platelet count ≥ 100 x10^9/L, and
    c. Hemoglobin > 8 g/dL.
    6. Adequate renal and hepatic function assessed during Screening, as indicated by:
    a. Estimated creatinine clearance ≥ 50 mL/min calculated by the Cockcroft-Gault method,
    b. Bilirubin, aspartate transaminase, alanine transaminase < 1.5 x upper limit of normal (ULN), and
    c. Alkaline phosphatase < 2.5 x ULN.
    7. Female patients with childbearing 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 2 reliable methods of contraception throughout the treatment period and for 3 months after discontinuation of treatment. The 2 methods of reliable contraception must include 1 highly effective method (intrauterine device, hormonal pills, injections or implants, tubal ligation, partner’s vasectomy), and 1 additional effective (barrier) method (diaphragm, cervical cap, male condom). True abstinence is acceptable when this is in line with the patient’s preferred and usual lifestyle. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
    8. Written informed consent given before any study-related assessment is performed.
    9. Patient is able and willing to co-operate with the requirements of the study.
    E.4Principal exclusion criteria
    1. Pregnant or breast-feeding women.
    2. Co-existing active infection, or received systemic anti-infectives within 4 weeks prior to the first dose of chemotherapy (Day 1 of Cycle 1).
    3. Significant cardiovascular disease defined as any history of documented or current congestive heart failure, current high-risk uncontrolled arrhythmias, current uncontrolled angina pectoris, current clinically significant valvular disease, current evidence of transmural infarction on ECG, or any other significant cardiovascular disease which in the Investigator’s judgment contraindicates the planned therapy (especially doxorubicin).
    4. Any malignancy other than the current breast cancer within the last 5 years prior to randomization, with the exception of cervical carcinoma in situ, non-melanoma skin cancer, or superficial bladder tumors (Ta, Tis, or T1) that have been successfully and curatively treated with no evidence of recurrent or residual disease.
    5. Radiation therapy within 4 weeks prior to randomization into this study.
    6. Concurrent anti-cancer therapy, including endocrine therapy, immunotherapy and monoclonal antibody therapy, and any concurrent treatment with bisphosphonates.
    7. Prior bone marrow or stem cell transplantation.
    8. Sickle cell disease.
    9. Other investigational drug administration within 4 weeks prior to the first dose of chemotherapy (Day 1 of Cycle 1).
    10. Previous exposure to filgrastim, lenograstim, or pegfilgrastim.
    11. Known allergy to any of the study drugs, including chemotherapy agents.
    12. Contraindication for use of corticosteroids.
    13. Systemic corticosteroid therapy within 2 weeks prior to randomization into this study. The use of topical or inhaled corticosteroids within 2 weeks prior to randomization may be allowed at the discretion of the Investigator.
    14. Any co-existing medical condition that in the Investigator’s judgment will substantially increase the risk associated with the patient’s participation in the study.
    E.5 End points
    E.5.1Primary end point(s)
    Duration of severe neutropenia (ANC < 0.5 x10^9/L) in Cycle 1
    E.5.1.1Timepoint(s) of evaluation of this end point
    The length of severe neutropenia in Cycle 1 (given in days) will be determined via daily ANC assessments at the end of Cycle 1.
    E.5.2Secondary end point(s)
    1. Duration of severe neutropenia (ANC < 0.5 x10^9/L) in Cycles 2, 3 and 4
    2. Incidence of severe neutropenia in Cycle 1
    3. Incidence of severe neutropenia in Cycle 2
    4. Observed incidence of febrile neutropenia in Cycles 1 and 2
    5. Overall incidence of febrile neutropenia in Cycles 1 and 2
    6. Time to ANC recovery (reaching ANC ≥ 2 x10^9/L) in Cycles 1 and 2
    7. Depth of ANC nadir in Cycles 1 and 2
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Length of severe neutropenia in Cycles 2-4 (days) will be determined via daily ANC assessments at end of Cycle 2-4.
    2. Proportion of patients developing severe neutropenia will be determined via daily ANC assessments in Cycle 1.
    3. Proportion of patients developing severe neutropenia will be determined via daily ANC assessments in Cycle 2-4.
    4. and 5. Incidence of febrile neutropenia will be evaluated in Cycle 1-2.
    6. Time to ANC recovery is the no. of days from the time of the first ANC value <0.5 10^9/L until the time of first ANC value after this, where the ANC value is ≥2.0 x 10^9/L.This will be evaluated in Cycle 1-2.
    7. Depth of nadir defined as the change from baseline ANC value (value at Day-1,Cycle 1) to the lowest value in the cycle and evaluated for Cycle 1-2.
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA31
    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
    Russian Federation
    Serbia
    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
    The date of the last protocol-specified visit/assessment for the last patient in the study or the date the study is closed by the Sponsor, whichever occurs first.
    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 months6
    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 months6
    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) No
    F.1.2.1Number of subjects for this age range: 230
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state63
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 137
    F.4.2.2In the whole clinical trial 240
    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
    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 Decision2013-12-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-04-08
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