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    Summary
    EudraCT Number:2013-000422-58
    Sponsor's Protocol Code Number:D4203C00011
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-06-10
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2013-000422-58
    A.3Full title of the trial
    A Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Phase III Study to Assess the Efficacy and Safety of Vandetanib (CAPRELSA?) 300 mg in Patients with Papillary or Poorly Differentiated Thyroid Cancer That Is Either Locally Advanced or Metastatic Who Are Refractory or Unsuitable for Radioiodine (RAI) Therapy.
    Ensayo fase III multicéntrico, aleatorizado, doble ciego y controlado con placebo, para evaluar la eficacia y seguridad de Vandetanib (CAPRELSA®) 300 mg en pacientes con cáncer de tiroides papilar o pobremente diferenciado localmente avanzado o metastásico, refractarios o no aptos para tratamiento con radioyodo (RAI).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of efficacy and safety of vandetanib in patients with advanced papillary or poorly differentiated thyroid cancer.
    Evaluación de la eficacia y seguridad de Vandetanib en pacientes con cáncer de tiroides papilar avanzado o pobremente diferenciado.
    A.4.1Sponsor's protocol code numberD4203C00011
    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 Address"
    B.5.3.2Town/ city"
    B.5.3.3Post code"
    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 Yes
    D.2.1.1.1Trade name CAPRELSA
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB, Sweden
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameCaprelsa
    D.3.2Product code ZD6474
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNVANDETANIB
    D.3.9.1CAS number 443913-73-3
    D.3.9.2Current sponsor codeZD6474
    D.3.9.4EV Substance CodeSUB29174
    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 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 placeboFilm-coated tablet
    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
    Papillary Differentiated Thyroid Cancer, Poorly Differentiated Thyroid Cancer
    Cáncer de tiroides papilar diferenciado, cáncer de tiroides papilar pobremente diferenciado.
    E.1.1.1Medical condition in easily understood language
    Vandetanib, ZD 6474, Differentiated Thyroid Cancer.
    Vandetanib, ZD6474, Cáncer de tiroides papilar diferenciado.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10071029
    E.1.2Term Thyroid cancer stage III
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10071030
    E.1.2Term Thyroid cancer stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10072162
    E.1.2Term Thyroid cancer recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10066474
    E.1.2Term Thyroid cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10055107
    E.1.2Term Thyroid cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10033701
    E.1.2Term Papillary thyroid cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the efficacy (as assessed by progression free survival (PFS)) of vandetanib when compared to placebo in patients with papillary or poorly differentiated thyroid cancer that is either locally advanced or metastatic who are refractory or unsuitable for radioiodine therapy.
    Determinar la eficacia (evaluada mediante la supervivencia libre de progresión (SLP)) de vandetanib en comparación con placebo en pacientes con cáncer tiroideo papilar o pobremente diferenciado que sea localmente avanzado o metastásico y que sean refractarios o no aptos para tratamiento con radioyodo.
    E.2.2Secondary objectives of the trial
    1. To determine the efficacy of vandetanib when compared to placebo in this patient population as assessed by efficacy variables including duration of response (DOR), objective response rate (ORR), change in tumour size (TS) and overall survival (OS).
    2. To evaluate the pharmacokinetics (PK) of vandetanib in this patient population and potentially investigate any influence of patient demography and pathophysiology on vandetanib PK.
    3. To demonstrate an improvement in time to worsening of pain (TWP) in patients treated with vandetanib when compared to placebo in this patient population.
    4. To evaluate the safety and tolerability of vandetanib treatment in this patient population.
    1. Determinar la eficacia de vandetanib en comparación con placebo en esta población de pacientes, evaluada mediante variables de eficacia, como la duración de la respuesta (DdR), la tasa de respuestas objetivas (TRO), el cambio en el tamaño tumoral (TT) y la supervivencia global (SG).
    2. Evaluar la farmacocinética (FC) de vandetanib en esta población de pacientes y potencialmente investigar cualquier influencia de los datos demográficos de los pacientes y de la fisiopatología sobre la FC de vandetanib.
    3. Demostrar una mejoría de tiempo hasta el empeoramiento del dolor (TED) en pacientes tratados con vandetanib en comparación con placebo en esta población de pacientes.
    4. Evaluar la seguridad y tolerabilidad del tratamiento con vandetanib en esta población de pacientes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Provision of informed consent to participate in the study as well as provision of informed consent to provide a sample of a previously obtained archival tumour biopsy
    Female or male aged 18 years and older with previously confirmed histological diagnosis of locally advanced or metastatic poorly differentiated or papillary thyroid cancer not amenable to surgical resection, external beam radiotherapy or other local therapy.
    Measurable disease defined as at least one lesion, not irradiated within 12 weeks of the date of randomisation, that can be accurately measured at baseline.
    Patients must have progression and be RAI-refractory/resistant or unsuitable for RAI.
    TSH suppression below 0.5 mU/L
    Firma del consentimiento informado para participar en el estudio, así como dar su consentimiento informado para aportar una muestra de una biopsia tumoral de archivo obtenida previamente.
    Mujeres o varones de 18 años y mayores con diagnóstico histológico confirmado previamente de cáncer tiroideo localmente avanzado o metastásico, papilar o pobremente diferenciado no susceptible de resección quirúrgica, radioterapia externa u otros tratamientos locales.
    Enfermedad medible, definida como al menos una lesión no irradiada dentro de las 12 semanas previas a la fecha de aleatorización, que pueda medirse con exactitud en el momento basal.
    Los pacientes deben haber progresado y ser refractarios/resistentes a RAI o no aptos para tratamiento con RAI
    Supresión de TSH por debajo de 0,5 mU/l.
    E.4Principal exclusion criteria
    Risk of prolonged QTc as defined by history of QT prolongation; current therapy with any medication known to be associated with Torsades de Pointes or prolongation of QT; congenital long QT syndrome.
    Previous therapy with approved or investigational tyrosine kinase or anti-VEGF receptor inhibitors or targeted therapies (e.g. multi-targeted kinase inhibitors such as sorafenib, AMG-706, sunitinib, pazopanib, lenvatinib)
    RAI therapy within 12 weeks prior to first dose of study drug, and radiation therapy other than RAI, including external beam, if not completed prior to randomisation
    Inadequate organ function as defined by elevated ALT, AST, ALP or bilirubin; or creatinine clearance <50 ml/min
    Riesgo de QTc prolongado como se define por la historia de la prolongación del intervalo QT; tratamiento actual con cualquier medicamento con asociación conocida con Torsades de Pointes o prolongación de QT; síndrome de QT largo congénito.
    Tratamiento previo de la tirosina cinasa o anti-receptor del VEGF o terapias dirigidas, aprobados o en investigación (p. ej., inhibidores de la cinasa con múltiples dianas como sorafenib, AMG-706, sunitinib, pazopanib, lenvatinib).
    Tratamiento con RAI dentro de las 12 semanas previas a la primera dosis del fármaco del ensayo, y radioterapia distinta de RAI, incluida la radioterapia externa, si no se terminó antes de la aleatorización.
    Función inadecuada de órganos, definida por elevada ALT, AST, ALP o bilirrubina; o aclaramiento de creatinina < 50 ml/min.
    E.5 End points
    E.5.1Primary end point(s)
    To determine the efficacy (as assessed by progression-free survival) of vandetanib when compared to placebo in the patient population.
    Determinar la eficacia (evaluada mediante la supervivencia libre de progresión (SLP)) de vandetanib en comparación con placebo en la población pacientes.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Once 155 progression events have occurred. This is estimated as 25.5 months (18 months recruitment period plus 7.5 months follow-up). RECIST measurements taken every 12 weeks from randomization.
    Una vez se hayan producido 155 acontecimientos de progresión. Esto se estima en 25,5 meses (18 meses del periodo de reclutamiento más 7,5 meses del periodo de seguimiento). Mediciones RECIST tomadas cada 12 semanas desde la aleatorización.
    E.5.2Secondary end point(s)
    To determine the efficacy of vandetanib when compared to placebo in the patient population as assessed by efficacy variables including duration of response, objective response rate, change in tumour size and overall survival.
    To evaluate the pharmacokinetics of vandetanib in the patient population by assessment of CL/F, V/F, Cmax and AUCss
    To demonstrate an improvement in time to worsening of pain in patients treated with vandetanib when compared to placebo in the patient population
    To evaluate the safety and tolerability of vandetanib treatment in the patient population by assessment of adverse events, vital signs, laboratory parameters and electrocardiographics
    Determinar la eficacia de vandetanib en comparación con placebo en esta población de pacientes evaluada mediante variables de eficacia, como la duración de la respuesta, la tasa de respuestas objetivas, el cambio en el tamaño tumoral y la supervivencia global.
    Evaluar la farmacocinética de vandetanib en esta población de pacientes mediante la evaluación de CL/F y V/F, Cmáx y AUCss.
    Demostrar una mejoría de tiempo hasta el empeoramiento del dolor en pacientes tratados con vandetanib en comparación con placebo en esta población de pacientes.
    Evaluar la seguridad y tolerabilidad del tratamiento con vandetanib en esta población de pacientes mediante la evaluación de acontecimientos adversos, constantes vitales, parámetros de laboratorio y electrocardiogramas.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Once 155 progression events have occurred. Analysis of overall survival to be repeated when 50% of randomised patients have died due to any cause. Estimated at 20 months after initial 25.5 months
    Blood sampling at 4-6 hours post-dose at Weeks 1, 2, 4, 8, 12 and then 12 weekly thereafter until discontinuation
    Once 155 progression events have occurred. Patient assessments at baseline, week 4, 8, 12 and then 12 weekly thereafter
    Once 155 progression events have occurred. Safety assessments at baseline, Weeks 1, 2, 4, 8, 12 and then 12 weekly thereafter
    Una vez se hayan producido 155 acontecimientos de progresión. El análisis de la supervicencia global se repetirá cuando el 50% de los pacientes aleatorizados hayan fallecido debido a cualquier causa. Estimado a los 20 meses después de los primeros 25,5 meses.
    Las muestras de sangre se recogerán en el plazo de 4-6h. después de la dosis del fármaco del ensayo en las semanas 1,2,4, 8,12 y después cada 12 semanas en adelante hasta la discontinuación.
    Una vez se hayan producido 155 acontecimientos de progresión. Evaluaciones de los pacientes al inicio del estudio, semana 4, 8, 12 y después cada 12 semanas en adelante.
    Una vez se hayan producido 155 acontecimientos de progresión. Evaluaciones de seguridad al inicio del estudio, las semanas 1, 2, 4, 8, 12 y después cada 12 semanas en adelante.
    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 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) Yes
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    China
    Czech Republic
    Denmark
    France
    Italy
    Japan
    Poland
    Russian Federation
    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
    LSLV
    La última visita del último paciente que participe en el ensayo.
    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 months10
    E.8.9.1In the Member State concerned days21
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days21
    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: 128
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 127
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 96
    F.4.2.2In the whole clinical trial 227
    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)
    None
    Ninguno
    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 Decision2013-08-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-11
    P. End of Trial
    P.End of Trial StatusCompleted
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