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    The EU Clinical Trials Register currently displays   36392   clinical trials with a EudraCT protocol, of which   5996   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2013-000423-14
    Sponsor's Protocol Code Number:D1532C00065
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-05-09
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-000423-14
    A.3Full title of the trial
    A Randomised, Double Blind Study to Compare the Complete Remission Rate Following a 5-Week Course of Selumetinib or Placebo and Single Dose Adjuvant Radioactive Iodine Therapy in Patients with Differentiated Thyroid Cance
    Studio randomizzato, in doppio cieco per confrontare la percentuale di remissione completa in seguito ad un trattamento di 5 settimane con Selumetinib o placebo e singola dose di terapia adiuvante con iodio radioattivo in pazienti con tumore differenziato della tiroide
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study comparing complete remission after treatment with selumetinb/palcebo in patients with differentiated thyroid cancer
    Studio che confronta la remissione completa dopo il trattamento con selumetinib / placebo in pazienti con tumore differenziato della tiroide
    A.3.2Name or abbreviated title of the trial where available
    ASTRA
    ASTRA
    A.4.1Sponsor's protocol code numberD1532C00065
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointInformation Centre
    B.5.3 Address:
    B.5.3.1Street AddressNot Applicable
    B.5.3.2Town/ cityNot Applicable
    B.5.3.3Post codeNot Applicable
    B.5.3.4CountryUnited States
    B.5.6E-mailInformation.centre@astrazeneca.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 nameSelumetinib
    D.3.2Product code AZD6244 blue 25 mg capsule
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNselumetinib
    D.3.9.1CAS number 943332-08-9
    D.3.9.2Current sponsor codeAZD2624 Hydrogen Sulfate
    D.3.9.3Other descriptive nameModified INN: Selumetinib hydrogen sulphate
    D.3.9.4EV Substance CodeSUB36237
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Differentiated Thyroid Cancer
    tumore differenziato della tiroide
    E.1.1.1Medical condition in easily understood language
    Thyroid Cancer
    tumore della tiroide
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of selumetinib with radioactive iodine therapy (RAI), versus placebo with RAI, by assessment of complete remission rate at 18 months post RAI treatment in the overall study population.
    To compare the efficacy of selumetinib with RAI, versus placebo with RAI, by assessment of complete remission rate at 18 months post RAI treatment in a sub-group of patients with tumours known to be mutation positive for BRAF or NRAS
    Confrontare l'efficacia di selumetinib con radioiodioterapia, rispetto al placebo con radioiodioterapia in termini di valutazione del tasso di remissione completa a 18 mesi dopo il trattamento radioiodioterapico nella popolazione generale dello studio.
    Confrontare l'efficacia di selumetinib con radioiodioterapia rispetto al placebo con radioiodioterapia mediante la valutazione del tasso di remissione completa a 18 mesi dopo il trattamento radioiodioterapico in un sottogruppo di pazienti con tumori noti per essere positivi alla mutazione BRAF o NRAS
    E.2.2Secondary objectives of the trial
    To compare the efficacy of selumetinib with RAI, versus placebo with RAI by assessment of clinical remission rate at 18 months post RAI treatment in the overall study population
    To compare the efficacy of selumetinib with RAI, versus placebo with RAI by assessment of clinical remission rate at 18 months post RAI treatment in a sub-group of patients with tumours known to be mutation positive for BRAF or NRAS
    To assess the safety and tolerability of selumetinib with RAI compared to placebo with RAI.
    To investigate the pharmacokinetics (PK) of selumetinib and N-desmethyl selumetinib when administered to patients with differentiated thyroid cancer.
    Confrontare l'efficacia di selumetinib con radioiodioterapia rispetto al placebo con radioiodioterapia in termini di valutazione del tasso di remissione clinica a 18 mesi dopo trattamento radioiodioterapico nella popolazione generale di studio.
    Confrontare l'efficacia di selumetinib con radioiodioterapia rispetto al placebo con radioiodioterapia per la valutazione del tasso di remissione clinica a 18 mesi dopo il trattamento radioiodioterapico in un sottogruppo di pazienti con tumori noti per essere positivi alla mutazione BRAF o NRAS
    Valutare la sicurezza e la tollerabilità di selumetinib con la radioiodioterapia rispetto al placebo con la radioiodioterapia.
    Studiare la farmacocinetica (PK) di selumetinib e N-desmethyl selumetinib quando somministrato a pazienti con carcinoma differenziato della tiroide.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Confirmed follicular cell derived differentiated thyroid cancer
    Post-surgery staging categories: primary tumour greater than 4 cm or gross extrathyroidal extension (T4 disease) or at least 1 lymph node that is 1 cm or larger or 5 or more involved lymph nodes (of any size)
    Previous one or two stage total thyroidectomy with therapeutic neck dissection of metastatic lymph nodes
    Patient must be suitable for radioactive iodine therapy
    Patient must be suitable for TSH suppresion
    - carcinoma differenziato della tiroide derivato dalle cellule follicolari confermato istologicamente o citologicamente
    - categorie di stadiazione post-chirurgica:
    • tumore primario di dimensioni maggiori di 4 cm
    • tumore primario di qualsiasi dimensione con estensione extratiroidea totale al di fuori della ghiandola tiroide (T4)
    • N1a o N1b con almeno 1 linfonodo ≥ 1 centimetro
    • N1a o N1b che coinvolge 5 o più linfonodi (di qualsiasi dimensione)
    - precedente tiroidectomia totale in una o due fassi con dissezione terapeutica del collo dei linfonodi metastatici.
    - paziente deve essere idoneo per la terapia radioattiva con iodio
    - paziente deve essere idoneo per la soppressione con TSH
    E.4Principal exclusion criteria
    Known distant metastaic disease at study entry
    Diagnosis of anaplastic thyroid cancer, modullary thyroid cancer or Hurthle cell carcinoma
    Presence of anti-Tg antibodies at screening
    Previous treatment with 131 I (RAI) or external beam radiation therapy (EBRT)
    Unresolved toxicit ≥ CTCAE Grade 2 from any previous therapy
    Conoscenza iniziale della progressione delle metastasi
    Diagnosi del tumore anaplastico alla tiroide, tumore midollare alla tiroide o carcinoma cellulare….
    Presenza al controllo di anticorpi anti-Tg
    Precedente trattamento con 131 I (RAI) o terapia con fascio esterno (EBRT)
    Tossicità irrisolte ≥ CTCAE di 2 grado da qualsiasi terapia precedente
    E.5 End points
    E.5.1Primary end point(s)
    Complete remission rate in overall study population
    Complete remission rate in sub-group of patients with tumours known to be mutation positive for BRAF or NRAS
    Tasso di remissione completa nella popolazione generale dello studio
    Tasso di remissione completa nel sottogruppo di pazienti con tumori noti per essere positivi alla mutazione BRAF o NRAS
    E.5.1.1Timepoint(s) of evaluation of this end point
    Measured at 18 months post RAI treatmen
    Misurato a 18 mesi dopo radioiodioterapia
    E.5.2Secondary end point(s)
    Clinical remission rate in overall study population
    Clinical remission rate in sub-group of patients with tumours known to be mutation positive for BRAF or NRAS
    Frequency and severity of adverse events
    Assess the pharmacokinetics of selumetinib and/or N-desmethyl selumetinib by assessment of parameters including area under the curve over time (AUC) and maximum concentration
    Tasso di remissione clinica nella popolazione generale dello studio
    Tasso di remissione clinica nel sottogruppo di pazienti con tumori noti per essere positivo per mutazione BRAF o NRAS
    Frequenza e gravità degli eventi avversi
    Valutazioni sulla farmacocinetica di selumetinib e / o selumetinib N-demetilato mediante parametri tra cui curva AUC e la concentrazione massima
    E.5.2.1Timepoint(s) of evaluation of this end point
    Measured at 18 months post RAI treatment
    AE's Measured throughout the study until 3 years post RAI treatment
    PK - In total 8 blood samples will be collected: 4 samples on pre defined time windows on Day1, and 4 samples on Day 29 or Day 30
    Misurato a 18 mesi dopo dopo radioiodioterapia
    Gli eventi avversi sono raccolti durante lo studio e fino a 3 anni dopo radioiodioterapia
    PK - in totale saranno raccolti 8 campioni di sangue: 4 campioni in tempi prestabiliti al giorno 1, gli altri 4 al giorno 29 o 30.
    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 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) 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) 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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
    Brazil
    France
    Germany
    Italy
    Poland
    Spain
    Sweden
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months5
    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: 135
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 115
    F.4.2.2In the whole clinical trial 228
    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)
    Standard of care
    Standard di cura
    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 Decision2013-07-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-09
    P. End of Trial
    P.End of Trial StatusOngoing
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