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    Summary
    EudraCT Number:2016-001930-93
    Sponsor's Protocol Code Number:GC-627-04
    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:2016-09-23
    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 number2016-001930-93
    A.3Full title of the trial
    A Phase III, Randomized, Multi-Centre, Double-Blind, Placebo Controlled Clinical Trial of F-627 in Women with Breast Cancer Receiving Myelotoxic Chemotherapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    New Drug F-627 Treatment of Women with Breast Cancer Receiving Myelotoxic Chemotherapy
    A.4.1Sponsor's protocol code numberGC-627-04
    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 SponsorGeneron (Shanghai) Corporation Ltd.
    B.1.3.4CountryChina
    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 supportGeneron (Shanghai) Corporation Ltd.
    B.4.2CountryChina
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGeneron (Shanghai) Corporation Ltd.
    B.5.2Functional name of contact pointCall Center
    B.5.3 Address:
    B.5.3.1Street AddressBuilding 9, 787 Kang Qiao Road
    B.5.3.2Town/ cityShanghai,
    B.5.3.3Post code201315
    B.5.3.4CountryChina
    B.5.6E-mailGC-627-04@generonbiomed.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 nameF-627
    D.3.2Product code F-627
    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 INNNA
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeF-627
    D.3.9.3Other descriptive nameRecombinant fusion protein with human granulocyte-colony stimulating factor (hG-CSF) fused to human immunoglobulin IgG2-Fc
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 No
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Women, between 18 and 75 years of age that have been diagnosed with Stage II-IV breast cancer in the adjuvant or metastatic setting and are scheduled to undergo chemotherapy. This is a profilaxis for myleotoxic chemotherapy induced neutropenia.
    Subjects with a history of prior malignancy other than breast cancer may enter the study if the malignancy is in remission. and not receiving active treatment.
    E.1.1.1Medical condition in easily understood language
    To aid in the recovery of white blood cells post chemotherapy treatment.
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    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
    The objective of the study is to evaluate the efficacy and safety of F-627 given as a single fixed dose pre-filled syringe in the subject’s first
    chemotherapy cycle in comparison to Placebo.
    E.2.2Secondary objectives of the trial
    - To assess safety in patients treated with the a fixed dose of F-627 identified in this protocol using the AE/SAE reporting, and other standard lab findings including hematology and blood chemistry, urinalysis, and symptoms including, but not limited to, bone and back pain.
    - Analysis of serum samples from cycles 2 to 4 to assess if antibodies to F-627 are present and, if present, to evaluate the biological effects. Antibodies of interest are the immunoglobulin (Ig) G and IgM antibodies
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Show evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial.
    2) Females ≥ 18 years of age and < 75 years of age.
    3) Diagnosed with Stage II-IV breast cancer.
    4) Subject is scheduled to undergo 4 cycles of TA chemotherapy (docetaxel, doxorubicin, 75, and 60 mg/m2, respectively).
    5) ECOG Performance status of ≤ 2.
    6) White Blood Cell count (WBC) ≥ 4.0 × 109/L, hemoglobin ≥ 11.5 g/dL and a platelet count ≥ 150 × 109/L.
    7) Demonstrate adequate renal, hepatic function (Liver function tests (ALT, AST, alkaline phosphatase and total bilirubin)) should be less than 2.5x upper limits of normal (ULN). Serum creatinine should be less than 1.7x ULN.
    8) All subjects must agree to use at least one of the following types of contraception: intrauterine device, implantable progesterone device, progesterone intramuscular injection, or oral contraceptive, which has been started at least one month prior to visit one and will continue for the duration of the trial. The contraceptive patch or condom use with spermicide is also acceptable forms of contraception as long as they will be used continually throughout the duration of the trial
    E.4Principal exclusion criteria
    1) Subject is <18 or ≥ 75 years of age.
    2) Disease progression has occurred while receiving a taxane regimen.
    3) Subject has undergone radiation therapy within 4 weeks of enrollment.
    4) Subject has undergone bone marrow or stem-cell transplantation.
    5) Subject has a history of prior malignancy other than breast cancer that is NOT in
    remission.
    6) Subjects that have used G-CSF or any other drug that may potentiate the release of neutrophils (i.e. lithium) within 6 weeks of the screening period are excluded.
    7) Subject has had chemotherapy within 365 days of screening.
    8) Subject has documented congestive heart failure, cardiomyopathy or myocardial infarction by clinical diagnosis, ECG test, or any other relevant test.
    9) History of alcohol or drug abuse that would interfere with the ability to be compliant with the study procedure.
    10) Unwillingness to participate in the study.
    11) Any underlying medical condition that, in the Investigator’s opinion, would make the administration of study drug hazardous to the patient or that would obscure the interpretation of adverse events.
    12) Receiving other investigational drugs or biologics within 1 month or five half lives of enrollment.
    13) Any condition, which can cause splenomegaly.
    14) Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease.
    15) ALT, AST, alkaline phosphatase, total bilirubin ≥ 2.5 upper limit of normal.
    16) Subject with active infection, or known to be infected with chronic active Hepatitis B within the last 1 year (unless shown at the time of study entry to be Hepatitis B antigen negative), or having any history of Hepatitis C.
    17) Women who are pregnant or breast-feeding.
    18) Subject known to be seropositive for HIV, or who have had an AIDS defining illness or a known immunodeficiency disorder.
    19) Subject with a history of tuberculosis or exposure to tuberculosis. Patients that have received a prior chest X-ray for suspicion of tuberculosis are also excluded unless they have been confirmed to be PPD negative or they had latent tuberculosis that has
    been previously treated.
    20) Subjects with Sickle Cell disease 21) Subjects with known hypersensitivity to E.coli-derived proteins‚ pegfilgrastim‚filgrastim, or any other component of the study drug.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint of the study will be the duration of grade 4 (severe) neutropenia (ANC < 0.5 x 109/L) observed in chemotherapy cycle 1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Cycle 1, Day 2-21
    E.5.2Secondary end point(s)
    For all secondary analyses, the endpoints will be measured for each cycle as well as over all cycles.
    • The duration in days of grade 4 (severe) neutropenia (ANC < 0.5 × 109/L) for chemotherapy cycles 2, 3, and 4, and over all cycles.
    • The duration in days of grade 2 (mild, ANC < 1.5 × 109/L) and 3 (moderate, ANC < 1.0 × 109/L) neutropenia () for each chemotherapy cycle and over all cycles.
    • The incidence rates of febrile neutropenia (defined as a single oral temperature of ≥38.3°C (101°F) or a temperature of >38.0°C (100.4°F) sustained for >1 hour and ANC < 0.5 x 109/L) for each chemotherapy cycle and over all cycles.
    • The incidence rates of grade 2, grade 3, and grade 4 neutropenia for all chemotherapy cycles.
    • The time in days to ANC recovery post nadir for each chemotherapy cycle and over all cycles; recovery defined as an ANC ≥ 2.0 × 109/L after the expected ANC nadir.
    • The depth of the ANC nadir for each chemotherapy cycle and over all cycles.
    • The incidence rates of infections for each chemotherapy cycle and over all cycles.
    • The use of antibiotic and pain medications for each chemotherapy cycle and over all cycles.
    • ECG endpoints: Change-from-baseline heart rate, PR, QRS and QTcF intervals. Categorical outliers and T-wave morphology changes on treatment.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The duration in days of grade 4 (severe) neutropenia (ANC < 0.5 × 109/L) for chemotherapy cycles 2, 3, and 4, and over all cycles.
    l The duration in days of grade 3 (moderate) and grade 4 (severe) neutropenia (ANC < 1.0 × 109/L and ANC < 0.5 × 109/L, respectively) for chemotherapy cycles 2, 3, 4, and over all cycles
    l The duration in days of grade 2 (mild), grade 3 (moderate) and 4 (severe) neutropenia (ANC < 1.5 × 109/L) for each chemotherapy cycle and over all cycles.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    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) No
    E.8.2.2Placebo Yes
    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 concerned5
    E.8.5The trial involves multiple Member States No
    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
    Hungary
    Russian Federation
    Ukraine
    United States
    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
    last visit of the last subject enter LVLS
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 100
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 120
    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)
    All subjects will receive an end of study assessment on Day 84 (or 3 weeks after the patient’s last dose of investigational agent). All adverse events will be followed until stabilization or resolution. Note: these dates are approximate as they are dependent upon an individual’s chemotherapy treatment schedule.
    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 Decision2017-01-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-11-28
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