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    Summary
    EudraCT Number:2009-012380-34
    Sponsor's Protocol Code Number:CNTO328MCD2001
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-10-16
    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 ConcernedFrance - ANSM
    A.2EudraCT number2009-012380-34
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and
    Safety of CNTO 328 (Anti-IL-6 Monoclonal Antibody) Plus Best Supportive Care
    Compared With Best Supportive Care in Subjects With Multicentric Castleman’s
    Disease
    A.4.1Sponsor's protocol code numberCNTO328MCD2001
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCentocor BV
    B.1.3.4CountryNetherlands
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/07/508
    D.3 Description of the IMP
    D.3.1Product nameCNTO328
    D.3.2Product code CNTO328
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous 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 codeCNTO 328
    D.3.9.3Other descriptive nameChimeric murine human anti-IL-6 monoclonal antibody
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typemonoclonal antibody
    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 placeboPowder for solution for infusion
    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
    Multicentric Castleman's disease
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10050251
    E.1.2Term Castleman's disease
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to demonstrate that CNTO 328 in combination with BSC is superior
    to BSC in terms of objective response (complete response [CR] + partial response [PR]) among subjects
    with multicentric Castleman’s disease (MCD).
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    • To demonstrate additional measures of efficacy (duration of tumor response; time to treatment failure; change in hemoglobin levels; ability to discontinue corticosteroids; and improvement in fatigue, physical function, and other disease-related symptoms)
    • To study the safety of prolonged dosing
    • To determine the pharmacokinetics of CNTO 328 among subjects with MCD
    • To determine a baseline hepcidin value predictive of a ≥ 2 g/dL increase in hemoglobin
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Measurable and symptomatic MCD proven by biopsy. Symptomatic disease is
    defined clinically by the presence of symptoms or by marked laboratory
    abnormalities with NCI-CTCAE grading ≥ 1 that are attributable to the disease, and for which treatment is indicated. Subjects are required to have
    measurable disease, which may be limited to cutaneous lesions. Elevations in
    acute-phase proteins (CRP, fibrinogen) and increased ESR in the absence of other
    symptoms do not qualify as symptomatic disease.
    2. ≥ 18 years of age
    3. Pretreatment clinical laboratory values meeting these criteria within 4 weeks before treatment:
    a. Absolute neutrophil count (ANC) ≥ 1.0 x 109/L
    b. Platelets ≥ 75 x 109/L
    c. ALT; unfractionated alkaline phosphatase within 2.5 x ULN; if above 2.5 x ULN,
    subjects will be eligible if alkaline phosphatase liver fraction is within 2.5 x ULN;
    total bilirubin within 2.5 x ULN
    d. Serum creatinine ≤ 3.0 mg/dL
    4. ECOG Performance Status of 0, 1, or 2
    5. Corticosteroids dose that does not exceed 1 mg/kg/day of prednisone (or equivalent) and has remained stable or decreased over the 4 weeks before
    enrollment
    6. Subjects of childbearing potential must use adequate birth control measures.
    Negative pregnancy test (serum or urine beta human chorionic gonadotropin
    [β-HCG]) at screening (applicable to women of childbearing potential).
    7. Subjects (or their legally-acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. Informed consent must be obtained before performing any study-specific procedures.
    E.4Principal exclusion criteria
    1. HIV or HHV-8 positive
    2. Previous lymphoma
    3. Malignancies, except for adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or cancer other than lymphoma, from which the subject has been disease-free for ≥ 3 years.
    4. Concurrent medical condition or disease (eg, autoimmune disease, active systemic
    infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary disease) that is
    likely to interfere with study procedures or results, or that in the opinion of the
    investigator would constitute a hazard for participating in this study
    5. Use of disallowed therapies: other concomitant anti-tumor therapies for Castleman’s disease (eg, anti-CD20 antibodies, IL-6- or IL-6 receptor-targeted therapies, chemotherapy), biologic treatments such as anti-tumor necrosis factor α (TNFα) antibodies, immunosuppressive agents (except stable doses of corticosteroids), and erythropoietin stimulating agents (ESAs)
    6. Received an investigational drug (including vaccines), or received any systemic
    treatment for Castleman’s disease within 4 weeks (or in the case of rituximab, within
    8 weeks) before the planned start of treatment
    7. Major surgery within 4 weeks of treatment
    8. History of uncontrolled heart disease such as unstable angina, congestive heart
    failure, myocardial infarction within preceding 12 months, hemodynamic instability
    or known left ventricular ejection fraction (LVEF) < 30%, or clinically significant
    rhythm or conduction abnormality
    9. Clinically significant infections, including known hepatitis C infection or known to be
    hepatitis B surface antigen (HBsAg) positive
    10. History of allogeneic transplant (except corneal transplants)
    11. Known allergies, hypersensitivity, or intolerance to monoclonal antibodies or to
    murine, chimeric, or human proteins or their excipients
    12. Pregnant or nursing
    13. Vaccination with live, attenuated vaccines within 4 weeks of first administration of
    study agent
    14. Paraneoplastic pemphigus or bronchiolitis obliterans
    15. Any condition that, in the opinion of the investigator, would compromise the wellbeing of the subject or the study or prevent the subject from meeting or performing study requirements
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be objective tumor response (CR + PR) modified to allow assessment of measurable cutaneous lesions, as measured by Cheson criteria (Cheson et al, 2007; positron-emission tomography [PET] scan data, if obtained, will not be taken into account).
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    The end of study is defined as one year after the last subject starts study treatment.
    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days25
    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.1.3Elderly (>=65 years) Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    The subject's legally-acceptable representative must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
    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 18
    F.4.2.2In the whole clinical trial 75
    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)
    The study will end 1 year after the last subject is randomized into the study. At that time, any subject benefiting from treatment will be rolled over to a long term extension study. Otherwise, there are no further plans for treatment or care other than standard of care for MCD.
    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 Decision2010-01-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-11-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-03-01
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