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    Summary
    EudraCT Number:2012-003162-41
    Sponsor's Protocol Code Number:ET2012000058
    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:2013-06-11
    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 number2012-003162-41
    A.3Full title of the trial
    A randomized, multicenter, open-label, phase II study of the optimal scheme of administration of pazopanib in thyroid carcinoma
    Etude de phase II randomisée, multicentrique, en ouvert, du schema d'administration optimal du pazopanib dans le carcinome de la thyroïde
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Optimal scheme of administration of pazopanib in thyroid carcinoma
    Schema d'administration optimal du pazopanib dans le carcinome de la thyroide
    A.3.2Name or abbreviated title of the trial where available
    PAZOTHYR
    PAZOTHYR
    A.4.1Sponsor's protocol code numberET2012000058
    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 SponsorCentre Léon Bérard
    B.1.3.4CountryFrance
    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 supportInstitut National du Cancer (French NCI)
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportGlaxoSmithKline
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre Léon Bérard
    B.5.2Functional name of contact pointDRCI
    B.5.3 Address:
    B.5.3.1Street Address28, rue Laennec
    B.5.3.2Town/ cityLYON
    B.5.3.3Post code69008
    B.5.3.4CountryFrance
    B.5.4Telephone number+33 426 55 68 29
    B.5.5Fax number+33478 78 27 15
    B.5.6E-mailjulien.gautier@lyon.unicancer.fr
    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 VOTRIENT
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoGroup Ltd
    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 namepazopanib
    D.3.4Pharmaceutical form 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 INNPAZOPANIB
    D.3.9.1CAS number 444731-52-6
    D.3.9.4EV Substance CodeSUB29175
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200 to 400
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Iodine refractory Differentiated Thyroid Carcinoma
    Carcinome Differencié de la Thyroide réfractaire à l'iode
    E.1.1.1Medical condition in easily understood language
    Iodine refractory thyroid carcinoma
    Carcinome de la thyroide conventionnel réfractaire à l'iode radioactif
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10043702
    E.1.2Term Thyroid carcinoma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to compare the time to treatment failure in patients with continuous pazopanib versus intermittent pazopanib treatment
    L'objectif principal est de comparer le temps à échec du traitement chez des patients traités par pazopanib en continu versus par intermittence
    E.2.2Secondary objectives of the trial
    Before randomization:
    - To study the objective response rate at 6 months of pazopanib,
    - To study the disease control rate at 6 months of pazopanib,
    After randomization:
    - To compare the Progression-free survival between the 2 arms,
    - to compare the best response rate between the 2 arms,
    - To compare the duration of best response between the 2 arms,
    - To compare the overall survival between the 2 arms,
    - To compare the objective response rate between the 2 arms,
    - To compare the stable disease rate between the 2 arms,
    - To compare the quality of life between the 2 arms,
    Throughout the study:
    - To study the safety profile of pazopanib
    Avant la randomisation:
    - Evaluer le taux de réponses objectives à 6 mois de traitement par pazopanib
    - Evaluer le taux de controle de la maladie à 6 mois de traitement par pazopanib,
    Après la randomisation:
    - Comparer la survie sans progression entre les 2 bras,
    - Comparer le taux de meilleure réponse entre les 2 bras,
    - Comparer la durée de la meilleure réponse entre les 2 bras,
    - Comparer la survie globale entre les 2 bras,
    - Comparer le taux de reponses objectives entre les 2 bras,
    - Comparer la qualité de vie entre les 2 bras,
    Tout au long de l'étude:
    - Evaluer le profil de tolérance du pazopanib
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Informed consent signature
    Differentiated thyroid carcinoma (DTC)
    Resistance to therapeutique radioiodine
    Disease progression
    ECOG Performance Status = 0 or 1
    Consentement éclairé signé
    Carcinome différencié de la thyoïde (DTC)
    Résistant à l'iode radioactif
    Progression de la maladie
    ECOG Performance Status = 0 ou 1
    E.4Principal exclusion criteria
    Other histological type than DTC
    Prior treatment with pazopanib
    Prior malignancy
    Active Central Nervous System metastasis
    Risk for gastrointestinal bleeding
    Poorly controlled hypertension
    Active bleeding or bleeding diathesis
    Type histologique autre que DTC
    Utilisation antérieure de pazopanib
    Antécédent de néoplasie
    Métastase active du Système Nerveux Central
    Risque de saignement gastrointestinal
    Hypertension non controlée
    Saignement actif ou prédisposition hémorragique
    E.5 End points
    E.5.1Primary end point(s)
    The Time to Treatment Failure (TTF) is the time from the date of randomization to the date of permanent treatment discontinuation due to any cause.
    Le temps jusqu'à échec du traitement est le temps entre la date de randomization et la date d'arrêt définitif du traitement, quelle qu'en soit la cause.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Until permanent discontinuation due to any cause.
    Jusqu'à arrêt définitif, quelle qu'en soit la cause.
    E.5.2Secondary end point(s)
    The Objective Response Rate (ORR) is the proportion of patients with a best overall response of Complete Response (CR) ou Partial Response (PR);
    The Disease Control Rate (DCR) is the proportion of patients with a best overall response of CR, PR or Stable Disease;
    The Progression-Free Survival (PFS) is the time from date of randomization to the date of event defined as the first documented progression under treatment or death due to any cause,
    The best response rate is the proportion of patients with a best overall response of CR and the proportion of patients with a best overall response of PR;
    The duration of response is the time from the first documented response (CR or PR when applicable) to the first documented disease progression or death due to any cause;
    The Overall Survival (OS) is the time from the date of randomization to the date of death due to any cause;
    The quality of life (QoL) will be studied with the score obtained at the EORTC QLQ-C30;
    The safety will be described by adverse events assessed according the NCI-CTC AE v4.03
    Le Taux de Réponses Objectives est la proportion de patients avec une meilleure réponse de type Réponse Complète (RC) ou Réponse Partielle (RP);
    Le Taux de Controle de la Maladie (TCM) est la proportion de patients avec une meilleure réponse de type RC, RP ou Maladie Stable;
    La Survie Sans Progression (SSP) est le temps entre la date de randomisation et la date de première progression documentée sous traitement ou la date de décès toutes causes;
    Le taux de meilleures réponses est la proportion de patients avec une meilleure réponse de type RC et la proportion de patients avec une meilleure réponse de type PR;
    La durée de réponse est le temps entre la date de première réponse documentée (RC ou RP - si applicable) et la date de première progression documentée ou la date de décès toutes causes;
    La Survie Globale (SG) est le temps entre la date de randomisation et la date de décès toute cause;
    La qualité de vie (QV) est étudiée par le score obtenu au QLQ-C30 de l'EORTC;
    La tolérance est évaluée à l'aide de l'échelle NCI-CTC AE v4.03.
    E.5.2.1Timepoint(s) of evaluation of this end point
    ORR: 6 cycles after pazopanib initiation and 6 cycles after randomization;
    DCR: 6 cycles after pazopanib initiation and 6 cycles after randomization;
    PFS: until progression or death;
    The best response will be assessed throughout the study;
    OS: until death;
    QoL: at screening, at randomization and at end of treatment;
    Safety: throughtout the study.
    TRO: 6 cycles après l'initiation du pazopanib et 6 cycles après la randomization;
    TCR: 6 cycles après l'initiation du pazopanib et 6 cycles après la randomization;
    SSP: jusqu'à progression ou décès;
    La meilleure réponse sera évaluée tout au long de l'étude;
    SG: jusqu'au décès;
    QV: au screening, à la randomisation et à la fin de traitement;
    Tolérance: tout au long de l'étude.
    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 Yes
    E.6.13.1Other scope of the trial description
    Biomarkers
    Biomarqueurs
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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
    Randomisation après 6 mois de traitement
    Randomization after 6 months of treatment
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Pazopanib en continu
    Continuous Pazopanib
    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 concerned12
    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
    6 months after the last patients randomized
    6 mois après la randomisation du dernier patient
    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: 84
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 84
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state168
    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)
    No drug with market approval is available for this population. Patients will be cared according the investigator's discretion. No protocol-specific recommmendation has been done.
    Aucune drogue n'a d'AMM pour cette population. Les patients seront traités à la discrétion de l'investigateur. Aucune recommandation spécifique au protocole n'est formulée.
    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 Decision2013-01-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-07-10
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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