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    Summary
    EudraCT Number:2015-002057-35
    Sponsor's Protocol Code Number:ZIN-130-1504
    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:2015-08-27
    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 number2015-002057-35
    A.3Full title of the trial
    A Phase 1-2 ascending dose study to assess the pharmacodynamics, pharmacokinetics, and safety of HSP 130 in subjects with non metastatic breast cancer following single dose and multiple dose administration by subcutaneous injection
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of the safety and effects of one or more doses of HSP-130 injected under the skin in patients with breast cancer that has not spread to distant sites in the body
    A.4.1Sponsor's protocol code numberZIN-130-1504
    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 SponsorHospira, Inc.
    B.1.3.4CountryUnited States
    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 supportHospira Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiorasi LLC
    B.5.2Functional name of contact pointEuropean Project Operations
    B.5.3 Address:
    B.5.3.1Street AddressNiermannsweg 11
    B.5.3.2Town/ cityErkrath
    B.5.3.3Post code40699
    B.5.3.4CountryGermany
    B.5.4Telephone number00491706392620
    B.5.5Fax number+49 211 2503 3233
    B.5.6E-mailhschmied@biorasi.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 nameHSP-130
    D.3.2Product code HSP-130
    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 INNN/A
    D.3.9.1CAS number 208265-92-3
    D.3.9.2Current sponsor codeHSP-130
    D.3.9.3Other descriptive namePegylated filgrastim
    D.3.9.4EV Substance CodeSUB16451MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.1CAS number 208265-92-3
    D.3.9.2Current sponsor codeHSP-130
    D.3.9.3Other descriptive namePegylated filgrastim
    D.3.9.4EV Substance CodeSUB16451MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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 Yes
    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
    Indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia
    E.1.1.1Medical condition in easily understood language
    Purpose is to lower the chance of getting fever or infection in patients with cancer who are getting a chemotherapy that can lower the number of white blood cells.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10021456
    E.1.2Term Immunodeficiency secondary to oncology chemotherapy
    E.1.2System Organ Class 100000004870
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Cycle 0:
    To characterize the pharmacodynamic (PD) response of absolute neutrophil count (ANC) and CD34+ count to HSP 130 at doses of 3 mg and 6 mg when administered as a single subcutaneous (SC) dose without chemotherapy to determine whether it is appropriate to study multiple doses of 3 mg with the context of background chemotherapy.
    Cycles 1 - 4:
    To characterize the PD response of duration of severe neutropenia (DSN) in Cycle 1 to HSP 130 over a range of doses when administered as single and multiple SC doses.
    E.2.2Secondary objectives of the trial
    Cycle 0:
    To characterize the pharmacokinetics (PK) of HSP 130 at doses of 3 mg and 6 mg when administered as a single SC injection without background chemotherapy.
    To characterize the safety of HSP 130 at doses of 3 mg and 6 mg when administered as a single SC dose without background chemotherapy.

    Cycles 1 - 4:
    To characterize the PD response of ANC to HSP 130 in Cycles 1 and 4 over a range of doses when administered as single and multiple SC doses.
    To characterize the PK of HSP 130 in Cycles 1 and 4 over a range of doses when administered as single and multiple SC doses.
    To characterize the safety of HSP 130 over a range of doses when administered as single and multiple SC doses.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Is informed, has been given ample time and opportunity to read about participation in the study and has signed and dated the written informed consent form approved by an Independent Ethics Committee (IEC) prior to any study related activities
    2. Females ≥ 18 years
    3. Histologically confirmed and documented invasive breast cancer
    4. Breast cancer without evidence of distant metastases (non-Stage 4) based on staging work-up
    5. Chemotherapy naïve, who have not received chemotherapy in the neoadjuvant setting and who are candidates for chemotherapy in the adjuvant setting of taxane/cyclophosphamide based regimen, i.e., TAC as background chemotherapy
    6. Zubrod/WHO/ECOG performance status ≤ 2
    7. Adequate bone marrow, hepatic, and renal function reserve as evidenced by:
    a. Hemoglobin ≥ 10 mg/dL
    b. ANC ≥ 1.5 x 109/L
    c. Platelet count of ≥ 100 x 109/L
    d. Total bilirubin ≤ 2 mg/dL
    e. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 3 x the upper limit of normal (ULN) of the reference lab
    f. Serum creatinine of ≤ 1.5 x ULN for reference lab or estimated glomerular filtration rate (eGFR) of ≥ 60 mg/min
    8. Subjects of childbearing potential, and their partners, agree to pregnancy prevention throughout the duration of the study (through the Follow up Visit). Specific type of pregnancy prevention should be discussed with, and acceptable to, the treating oncologist in the context of the tumoral hormone receptor status.
    9. Able to understand verbal or written instructions and comply with all study requirements, to communicate effectively with study personnel and is available for the planned duration of the study
    E.4Principal exclusion criteria
    1. Previous granulocyte colony stimulating factor (G CSF) exposure, including filgrastim, lenograstim, pegfilgrastim, lipegfilgrastim, granulocyte/macrophage colony stimulating growth factor (GM CSF), or any other branded or biosimilar G CSF
    2. Prior autologous stem cell harvest of any type
    3. Drug sensitivity, allergic reaction, or known hypersensitivity or idiosyncratic reaction to Escherichia coli (E. coli) derived proteins, filgrastim, other G CSFs, or pegylated agents
    4. Known hypersensitivity to docetaxel, polysorbate 80, or doxorubicin
    5. Chemotherapy other than that included in this study (i.e., taxane/cyclophosphamide-based regimen, i.e., TAC) or neoadjuvant chemotherapy; or known immunosuppressive agents including chronic oral corticosteroid use, or radiation therapy within 4 weeks of first dose of HSP 130, prior bone marrow or stem cell transplantation, or malignancy within 5 years
    6. Known HER2+ (overexpressing breast cancer)
    7. Known triple negative (estrogen receptor negative, progesterone receptor negative and HER2 negative) breast cancer
    8. Medical conditions including but not limited to: Known sickle cell disease; known severe persistent drug induced myelosuppression; severe uncontrolled cardiac disease; any malignancy other than breast with the exception of adequately treated squamous or basal cell carcinoma or the skin or cervical carcinoma in situ within 5 years; pregnancy or lactation; received live, live attenuated, or non live vaccine within 4 weeks
    9. Current or recent treatment (within 30 days before the first administration of the HSP 130) with any other Investigational Medicinal Product
    10. Patient has evidence of any other coexisting disease or medical or psychological condition, metabolic dysfunction, physical examination finding or clinical lab finding giving reasonable suspicion of a disease or condition that contraindicated the use of an HSP 130, or patient is high risk for treatment complication
    E.5 End points
    E.5.1Primary end point(s)
    Pharmacodynamic Endpoints:
    Cycle 0:
    • Primary Variable: Area under the effect curve for ANC (AUECANC)
    • Secondary Variables: Maximum effect for ANC (ANC_Emax), time of maximum effect for ANC (ANC Tmax), area under the effect curve for CD34+ (AUECCD34+), maximum effect for CD34+ count (CD34+_Emax), time of maximum effect for CD34+ count (CD34+ Tmax)

    Cycles 1 - 4:
    • Primary Variable: Duration of severe neutropenia (DSN). DSN is defined as days with grade 4 neutropenia (ANC < 0.5 x 109/L) in Cycle 1
    • Secondary Variables: DSN in Cycle 4. ANC nadir concentration, time of nadir concentration, area under the effect curve (AUEC), incidence of FN, defined as tympanic or axillary body temperature > 38.5°C for > 1 hour with ANC < 1.0 x 109/L, incidence of severe neutropenia (grade 4, ANC < 0.5 x 109/L) and time to ANC recovery (the first day with ANC ≥ 2.0 x 109/L after any day with ANC < 2.0 x 109/L) in Cycle 1 and Cycle 4
    E.5.1.1Timepoint(s) of evaluation of this end point
    Cycle 0:
    Pharmacodynamic sampling for absolute neutrophil count (ANC), CD34+ count will be collected within 1 hour prior to dose administration and at 48, 96, 144, 192, 240, and 312 hours post dose

    Cycles 1 - 4
    Pharmacodynamic sampling for absolute neutrophil count (ANC) will be collected within 1 hour prior to dose administration and at 48, 96, 144, 192, 240, and 312 hours post dose in Cycles 1&4 only
    E.5.2Secondary end point(s)
    Pharmacokinetic Endpoints:
    Cycle 0:
    •Primary Variables: Area under the serum HSP 130 versus time curve from the time of dose administration to time infinity (AUC0 ∞) and the maximum observed serum HSP 130 concentration (Cmax)
    •Secondary Variables: Area under the serum HSP 130 versus time curve from the time of dose administration to the time of last measurable concentration (AUC0 t), the time of maximum serum HSP 130 concentration (Tmax), elimination half life (t1/2), elimination rate constant (λz), and apparent clearance (CL)

    Cycles 1–4:
    •Primary Variables: AUC 0-t and Cmax
    •Secondary Variables: AUC 0-∞, Tmax, t1/2, λz, and CL
    E.5.2.1Timepoint(s) of evaluation of this end point
    Cycle 0:
    Pharmacokinetic sampling will be collected within 1 hour prior to dose at Day 1, and at 6, 12, 24, 48, 96, 144, 192, 240, and 312 hours post dose

    Cycles 1 - 4
    Pharmacokinetic sampling will be collected within 1 hour prior to dose and at 6, 12, 24, 48, 96, 144, 192, 240, and 312 hours post dose in Cycles 1&4 only
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.1.1First administration to humans Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 EEA10
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 end of study is defined as the day the last subject completes the Follow up Visit, 30 days after last dose of HSP 130, in Cycle 4 or is discontinued
    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 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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 48
    F.4.2.2In the whole clinical trial 48
    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)
    Cycle 0:
    Sponsor will reimburse investigator for use of EU-approved Neulasta for patients who received HSP-130 in the Cycle 0 part of the study.
    Cycles 1-4:
    Following study end the patients will receive care as determined by their treating physician.
    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 Decision2015-10-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-10-05
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