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    Summary
    EudraCT Number:2017-003028-59
    Sponsor's Protocol Code Number:NL62684.091.17
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-03-06
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2017-003028-59
    A.3Full title of the trial
    Treatment with Recombinant human Interleukin 1 receptor antagonist (Anakinra) in patients with Anaplastic Thyroid Cancer: a proof of concept study
    Behandeling met recombinant humaan Interleukine 1 receptor antagonist (Anakinra) in patiënten met Anaplastisch schildkliercarcinoom: een proof-of-concept studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment with Anakinra for patients with anaplastic thyroid cancer
    Proefbehandeling met Anakinra voor patiënten met anaplastisch schildklierkanker
    A.3.2Name or abbreviated title of the trial where available
    ATC-Anakinra1
    A.4.1Sponsor's protocol code numberNL62684.091.17
    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 SponsorRadboud University Medical Centre
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportRadboud University Medical Centre
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadboud University Medical Centre
    B.5.2Functional name of contact pointDepartment of Endocrinology
    B.5.3 Address:
    B.5.3.1Street AddressGeert Grooteplein zuid 8
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6525 GA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310243614599
    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 Yes
    D.2.1.1.1Trade name Kineret
    D.2.1.1.2Name of the Marketing Authorisation holderSwedish Orphan Biovitrum AB (publ)
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameKineret
    D.3.4Pharmaceutical form Solution for injection/infusion in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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) Yes
    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
    Anaplastic Thyroid Carcinoma
    anaplastisch schildkliercarcinoom
    E.1.1.1Medical condition in easily understood language
    anaplastic thyroid cancer
    anaplastische schildklierkanker
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the effect of treatment with human recombinant IL1Ra (rhIL1Ra, Anakinra) on health related quality of life (HRQoL), tumor progression and overall survival in patients with anaplastic thyroid carcinoma.
    Onderzoek naar het effect van de behandeling met anakinra in patienten met anaplastisch schildkliercaricnoom. Specifiek wordt het effect op kwaliteit van leven, tumor progressie en overleving.
    E.2.2Secondary objectives of the trial
    To investigate the effect of treatment with IL1Ra (Anakinra) in patients with ATC on;
    - performance status, measured with the Eastern Cooperative Oncology Group (ECOG) performance scale.
    - progression free survival (PFS): which is defined as the time interval from date of official diagnosis to date of first progression or death due to any cause, if death occurs before a progression is documented. Progression will be defined according to RECIST criteria.
    - safety in terms of occurrence and severity of adverse events according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) (35),
    - Measurements of (systemic) inflammation.


    Het effect van anakinra op performance, progressie-vrije overleving, veiligheid in termen van bijwerkingen, en metingen ten aanzien van systemische ontsteking.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - newly diagnosed patients with a proven diagnosis (cytology or histology) of ATC, for whom surgery is not feasible.
    - Patients with proven ATC (cytology or histology), presenting with metastasis not amendable for surgery.
    - age ≥ 18 years
    - ouder dan 18 jaar.
    - nieuwe diagnose anaplastisch schildkliercarcinoom, voor wie operatief ingrijpen geen optie meer is.
    - iemand met anaplastisch schildkliercarcinoom, die zich presenteert met metastasen en voor wie operatie geen optie meer is.
    E.4Principal exclusion criteria
    - unable to give informed consent
    - pregnancy or breast feeding
    - neutropenia (absolute neutrophil count (ANC)< 1.5 x10^9/l)
    - patients with a known history of allergic reactions to compounds of similar chemical or biological composition to Anakinra.
    - Any severe condition which could interfere with participation in this trial, including, but not limited to: severe renal dysfunction (creatinin clearance < 15 ml/min), severe cardiac failure, severe respiratory conditions etc.
    - Active infection; However, after adequate treatment of infections, patients will be eligible for inclusion again.
    - geen toestemming
    - zangerschap of borstvoeding
    - neutropenie (ANC<1.55 x10^9/l
    - patienten met allergie tegen anakinra of soortgelijk middel
    - ernstige aandoening die meedoen aan deze studie kan beïnvloeden, onder andere ernstig nerfalen, hartfalen of ernstige respiratoire aandoeningen.
    -actieve infectie (na adequate behandeling kunnen patienten alsnog deelnemen)
    E.5 End points
    E.5.1Primary end point(s)
    Health Related Quality of Life (HR-QoL): defined as outcome of the QoL life questionnaire specifically designed for anaplastic thyroid cancer patients
    Tumor dimensions/tumor progression: TNM classification and tumor size etc. This will be assessed using radiological examinations using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria .
    Overall survival (OS): defined as time interval from date of official inclusion to death due to any cause.
    kwaliteit van leven
    tumor dimensies/tumor progressie
    overleving
    E.5.1.1Timepoint(s) of evaluation of this end point
    4, 8 , 12 and 24 weeks after start of treatment imaging studie and laboratory tests to assess tumor status/tumor progression
    bi-weekly QoL questionaires .
    4, 8, 12, 24 weken tijdens behandeling vindt beeldvorming en bloedafname plaats om de tumor status/tumor progressie te beoordelen.
    Twee-wekelijks vragenlijst naar kwaliteit van elven.
    E.5.2Secondary end point(s)
    - Improved quality of life (QoL): defined as outcome of the QoL life questionnaire specifically designed for thyroid cancer patients, the THYCA-QoL in combination with the EORTC QLQ-C30.
    - The Eastern Cooperative Oncology Group (ECOG) performance status.
    - Progression free survival (PFS) based on imaging studies according to RECIST.
    - Effect of anakinra on Inflammatory parameters:
    • Systemic: CRP, fibrogen, feirritin, triglycerides, albumin, alfa-1-antitripsin, leukocyte counts, IL-6 levels
    • Cellular level: quantification and phenotyping of circulating immune cell populations; cytokine production in Peripheral Blood Mononuclear Cells (PBMCs).
    QoL vragenlijst:
    ECOG performance status
    RECIST: reductie tumorvolume
    inflammatoire parameters
    E.5.2.1Timepoint(s) of evaluation of this end point
    4, 8 , 12 and 24 weeks after start of treatment imaging studies to assess tumor status/tumor progression
    every month QoL questionaires and blood donations.
    4, 8, 12, 24 weken na behandeling vindt beeldvorming plaats om de tumor status/tumor progressie te beoordelen.
    Maandelijks vindt bloedonderzoek en afname van QoL vragenlijsten plaats.
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2018-03-06. Yes
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    incurable disease
    ongeneeslijk ziek
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    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)
    Patients will have the option to continue the use of anakinra for ATC.
    Patienten kunnen bij respons op therapie anakinra door blijven gebruiken als zij dat willen
    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 Decision2018-03-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-06
    P. End of Trial
    P.End of Trial StatusOngoing
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