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    Summary
    EudraCT Number:2012-001525-27
    Sponsor's Protocol Code Number:SNOXH94C201
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-05-07
    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 ConcernedAustria - BASG
    A.2EudraCT number2012-001525-27
    A.3Full title of the trial
    Phase IIa study to characterize the effects of the Spiegelmer® NOX-H94 on anemia of chronic disease in patients with cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase IIa study to investigate the efficacy of NOX-H94 in the treatment of anemia in patients with cancer.
    A.4.1Sponsor's protocol code numberSNOXH94C201
    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 SponsorNOXXON Pharma AG
    B.1.3.4CountryGermany
    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 supportNOXXON Pharma AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPierrel Research Europe GmbH
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressZeche Katharina 6
    B.5.3.2Town/ cityEssen
    B.5.3.3Post code45307
    B.5.3.4CountryGermany
    B.5.4Telephone number+4920189900
    B.5.5Fax number+492018990101
    B.5.6E-mailoffice.europe@pierrel-research.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 nameNOX-H94 Hepcidin Antagonist
    D.3.2Product code NOX-H94
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1322069-19-1
    D.3.9.2Current sponsor codeNOX-H94
    D.3.9.3Other descriptive nameNOX-H94 Hepcidin Antagonist
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number14.6
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    anemia of chronic disease in patients with cancer
    E.1.1.1Medical condition in easily understood language
    anemia in cancer patients
    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 16.0
    E.1.2Level LLT
    E.1.2Classification code 10007050
    E.1.2Term Cancer
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10054310
    E.1.2Term Anemia of chronic disease
    E.1.2System Organ Class 100000004851
    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 the response rate of anemia in patients with cancer to treatment with NOX-H94.
    E.2.2Secondary objectives of the trial
    - To determine the safety and tolerability of NOX-H94
    - To study the correlation between the exposure to NOX H94 with treatment response and with PD parameters.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The following inclusion criteria will be checked at the screening visit:
    1. Written informed consent
    2. Female or male aged >18 years
    3. Clinically significant anemia of chronic disease (ACD) attributed to histologically or cytologically proven malignancy, either hematological or solid tumor, of any grade or stage:
    • Hemoglobin (Hb) 7.0 g/dL to 10 g/dL,
    • Transferrin saturation (TSAT) <50%,
    • Serum iron <50 µg/dL (SI: <9.0 µmol/L)
    • Ferritin >30 ng/mL (SI: >30 µg/L)
    4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
    5. Estimated life expectancy ≥12 weeks

    6. Men must agree to follow effective contraception methods during treatment and for 3 months after completion of treatment. Women of childbearing potential must agree to use two forms of effective contraception during treatment and for 3 months after completion of treatment.
    E.4Principal exclusion criteria
    The following exclusion criteria will be checked at the screening visit. In addition, exclusion criteria 16 to 20 will be checked again at Visit 2 prior to randomization / first study drug administration
    1. Inability to personally provide written informed consent or to understand and collaborate throughout the study
    2. History of pure red cell aplasia, thalassemia major or sickle cell disease
    3. History of anemia unrelated to cancer <10 g/dL within 6 months prior to screening
    4. Uncorrected iron deficiency
    5. Regular need for blood transfusions at intervals <6 weeks
    6. Acute or myeloid leukemia
    7. Known or suspected chronic bleeding
    8. Tumor with gastro-intestinal involvement without negative test for fecal occult blood
    9. Suspected or known history of hemochromatosis
    10. Known infection with human immunodeficiency virus, hepatitis B, or hepatitis C
    11. Impaired liver function with bilirubin ≥2.0 mg/dL (26 μmol/L) or AST ≥2 times upper limit or ALT ≥2 times upper limit
    12. History or risk of significant hepatic disease, e.g. chronic alcohol abuse, hepatic steatosis, hepatic cirrhosis, or organ transplantation
    13. Severe renal impairment: estimated glomerular filtration rate (eGFR) <30 mL/min (Cockcroft-Gault)
    14. Known central nervous system malignancy or metastasis
    15. Significant cardiac disease (e.g. uncontrolled hypertension: systolic blood pressure [BP] >150 mmHg or diastolic BP >100 mmHg; myocardial infarction or unstable angina pectoris) within 6 months prior to screening
    16. Positive pregnancy test (serum ß-hCG at screening, urine pregnancy test prior to first treatment) or lactation
    17. Previous treatment with NOX H94 or treatment with an investigational agent <30 days prior to screening
    18. Hemolysis or bleeding >500 mL (measured or estimated) within 6 weeks prior to treatment start
    19. Treatment with ESAs or RBC transfusions <21 days prior to treatment start
    20. Cytotoxic anti-tumor treatment <21 days prior to treatment start or planned during the anticipated study period (within 3 months from treatment start or randomization). Maintenance therapy is permitted throughout the study (lenalidomide up to 15 mg/d, thalidomide 50 mg per day, bortezomib once every 2 weeks, rituximab, interferon)
    E.5 End points
    E.5.1Primary end point(s)
    Number of treatment responders as defined by either of the following criteria at any time up to 1 week after end of treatment:
    - Hb increase ≥1 g/dL
    - Reticulocyte index normalization (≥1%)
    And absence of all of the following treatment failure criteria until 1 week after the end of treatment:
    - Patients receiving RBC transfusion, ESA, or IV iron
    - Hb drop by ≥1 g/dL
    - Treatment interruption due to AE
    E.5.1.1Timepoint(s) of evaluation of this end point
    8 days (V4), 15 days (V6), 22 days (V8), 29 days (V10) and 85 days (V14) from start of treatment
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints:
    - absolute values and change from baseline at each study visit of
    - Hb, serum iron, transferrin, ferritin, transferrin saturation (
    TSAT), reticulocyte counts, RBC; soluble transferrin receptor
    (sTFR) and reticulocyte hemoglobin content (CHr) where
    available from local laboratory.
    - Hepcidin
    - Proportion of treatment responders at study visits V4, V6, V8, and V10 to V14, as defined for the primary efficacy endpoint
    - Proportion of treatment failures at study visits V4, V6, V8, and
    V10, as defined for the primary efficacy endpoint

    Safety and tolerability
    The following safety parameters will be evaluated: at screening or at randomization prior to first investigational medicinal product (IMP) administration and then as defined below and as outlined in the study flow-chart.
    - Vital signs and spontaneously reported adverse events will be recorded at all study visits.
    - 12-lead ECG at screening (Visit 1), after dosing at Visit 2 and
    Visit 10; additional ECGs will be recorded at the discretion of
    the investigator or if clinically significant changes from baseline
    were noted.
    - Safety laboratory examinations (full blood cell count, clinical
    chemistry) will be done at screening (Visit 1), prior to Doses 1,
    3, 5, 7, and 9 (Visits 2, 4, 6, 8, and 10) and after 1 week
    (Visit 11), 2 weeks (Visit 12) and 4 weeks (Visit 13) of follow
    up after treatment.

    Hematology: same parameters as used for efficacy assessment: EDTA-tube; RBC, Hb, packed cell volume (PCV), MCV, MCH, mean cell hemoglobin concentration MCHC, WBC, reticulocytes, differential blood count and platelet count.
    Clinical chemistry: serum separator tube; AP, ALT, AST, Gamma-GT, creatine kinase, LDH, albumin, total bilirubin, urea-N, creatinine, calcium, sodium, potassium, total protein, protein electrophoresis, chloride, inorganic phosphorus, uric acid, CRP, and glucose.
    Immunogenicity serum samples will be taken at screening, prior 9th IMP dose, and 4 and 8 weeks after the end of treatment.
    Unscheduled safety tests may be performed whenever clinically indicated by the discretion of the investigator and may extend beyond the scheduled study end until resolution of clinically significant abnormal findings.
    The safety will also be investigated for important subpopulations, depending on data availability. In particular, the effect of renal impairment on safety will be studied, to the extent permitted by the available data.

    Pharmacokinetics
    This clinical study will be used to confirm that the exposure to NOX H94 previously observed in healthy subjects corresponds to the exposure in patients with anemia of chronic disease. In order to minimize the burden to patients, the pharmacokinetic analyses will be based on a minimum of sampling time points and as a result, will be able to provide information only on maximum plasma concentrations (Cmax) and on potential accumulation. Samples for evaluation of the Cmax will be taken only from patients of the pilot group after the first and after the last IMP administrations. From patients enrolled in both phases of the clinical study, pre-dose plasma samples will be used to evaluate the accumulation of NOX H94 and will be taken before the first, second, fifth, and the last injections. Further PK samples are drawn one and two weeks after last treatment in order to document the elimination of NOX H94 from plasma.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy: V4, V6, V8, and V10 to V14
    Safety and tolerability: V1, V2, V4, V6, V8, V10, V11, V12, V13
    Pharmacokinetics: V2, V10, V11, V12
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    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) 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.7.1Other trial design description
    open-label pilot phase
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    LVLS
    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 months3
    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 months3
    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: 24
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    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 state10
    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)
    After the last study visit, Visit 14, no further medical care will be provided for patients as
    part of this clinical trial, with the exception of ongoing AEs requiring medical follow-up.
    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 Decision2012-06-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-12-30
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