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    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2013-002138-20
    Sponsor's Protocol Code Number:CURTAXEL
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-08-20
    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 number2013-002138-20
    A.3Full title of the trial
    Multicenter randomized phase II study, double-blind, comparing Taxotere plus curcumin versus Taxotere plus placebo combination in first-line treatment of prostate cancer metastatic castration resistant
    Etude multicentrique randomisé de phase II, en double aveugle, comparant l’association Taxotère plus curcumine versus Taxotère plus placebo en première ligne de traitement des cancers de la prostate métastatiques résistants à la castration
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multicenter randomized phase II study, double-blind, comparing Taxotere plus curcumin versus Taxotere plus placebo combination in first-line treatment of prostate cancer metastatic castration resistant
    Etude multicentrique randomisé de phase II, en double aveugle, comparant l’association Taxotère plus curcumine versus Taxotère plus placebo en première ligne de traitement des cancers de la prostate métastatiques résistants à la castration
    A.3.2Name or abbreviated title of the trial where available
    CURTAXEL
    CURTAXEL
    A.4.1Sponsor's protocol code numberCURTAXEL
    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 Jean Perrin
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre Jean perrin
    B.5.2Functional name of contact pointPouget Mélanie
    B.5.3 Address:
    B.5.3.1Street Address58, rue Montalembert
    B.5.3.2Town/ cityClermont-Ferrand
    B.5.3.3Post code63011
    B.5.3.4CountryFrance
    B.5.4Telephone number33473278497
    B.5.5Fax number33473278410
    B.5.6E-mailMelanie.POUGET@cjp.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 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 nameCurcumine
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product Yes
    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
    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
    metastatic prostate cancer
    cancer de la prostate métastique
    E.1.1.1Medical condition in easily understood language
    metastatic prostate cancer
    cancer de la prostate métastique
    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 10066489
    E.1.2Term Progression of prostate cancer
    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
    Assess time to progression (time to progression) of metastatic disease (from first day of treatment in the trial). Progression was defined as an increase (of) injury (s) tumor (s) (RECIST) or an increase in PSA levels (≥ 25% and ≥ 2ng/ml increase) or the appearance of new lesions metastatic (at least 2 new lesions for bone lesions).
    Evaluer le temps jusqu’à progression (Time to Progression) de la maladie métastatique (à partir du 1er jour de traitement dans l’essai). On définit la progression comme une augmentation de la (des) lésion(s) tumorale(s) (critères RECIST) ou une augmentation du taux PSA (≥ 25% d’augmentation et ≥ 2ng/mL) ou l’apparition de nouvelles lésions métastatiques (au moins 2 nouvelles lésions pour les lésions osseuses).
    E.2.2Secondary objectives of the trial
    Evaluate the PSA response (50% decrease compared to the value of the pre-processing).
    Evaluate the objective tumor response rate (CR + PR) by RECIST.
    Assess the safety of the combination Taxotere/ curcumin.
    Assess pain in the short questionnaire on pain (QCD), short version of the brief French Bread inventory.
    Assess serum neuroendocrine markers chromogranin A (CgA) and neuron specific enolase (NSE).
    Evaluate overall survival (between inclusion and death whatever the cause).
    Evaluate the anti-angiogenic activity of the association Taxotere ® plus curcumin (dosage serum VEGF).
    Assess the compliance by curcumin treatment / placebo orally for all patients included in the study.
    Evaluer la réponse du PSA (diminution de 50% par rapport à la valeur du pré-traitement).
    -Evaluer le taux de réponse tumorale objective (RC+RP) selon les critères RECIST.
    -Evaluer la tolérance de l’association Taxotère/curcumine.
    -Evaluer la douleur selon le questionnaire concis sur les douleurs (QCD), version française courte du brief Pain inventory.
    -Evaluer les marqueurs neuroendocrines sériques : la chromogranine A (CgA) et l’énolase neurone spécifique (NSE).
    -Evaluer la survie globale (entre l’inclusion et le décès quelle qu’en soit la cause).
    -Evaluer l’activité anti-angiogénique de l’association Taxotère® plus curcumine (dosage de VEGF sérique).
    -Evaluer la compliance au traitement par curcumine/placebo per os pour tous les patients inclus dans l’étude.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient older than 18 years.
    - Performance status ≤ 2 according to the WHO criteria.
    - Life expectancy> 3 months.
    - Patient in hormonal blockade based on surgical castration by orchiectomy or pulpectomy, medical or agonist or antagonists of LHRH associated or not with anti-androgens or any other treatment that blocks the fraction of non-gonadal testosterone, resulting in a testosterone <0.5 ng / mL.
    - Patient with adenocarcinoma of the prostate and histologically proven metastatic castration-resistant stage, defined by:
    o objective progression of at least one measurable tumor target and / or assessable by RECIST,
    o and / or increase in PSA ("rising PSA").
    - Satisfactory biological functions (renal, hepatic and hematologic)
    - Patient who signed the consent for participation before entering the study.
    - Affiliation to a social security scheme (or be the beneficiary of such a plan) under the terms of the law of 9 August 2004.
    Patient âgé de plus de 18 ans.
    - Performance status ≤ 2 selon les critères de l’OMS.
    - Espérance de vie > 3 mois.
    - Patient sous blocage hormonal reposant sur une castration chirurgicale par orchidectomie ou pulpectomie, ou médicale par agonistes ou antagonistes de la LH-RH associés ou non aux anti-androgènes ou à tout autre traitement bloquant la fraction de la testostérone non gonadique, résultant en une testostéronémie < 0,5 ng/mL.
    - Patient présentant un adénocarcinome de la prostate histologiquement prouvé et métastatique au stade résistant à la castration, défini par :
    ola progression objective d’au moins une cible tumorale mesurable et/ou évaluable selon les critères RECIST,
    oet/ou l’augmentation du taux de PSA (« rising PSA »).
    - Fonctions biologiques satisfaisantes (rénales, hépatiques et hématologique)
    - Patient ayant signé le consentement de participation avant l’entrée dans l’étude.
    - Affiliation à un régime de Sécurité Sociale (ou être bénéficiaire d’un tel régime) selon les termes de la loi du 9 août 2004.
    E.4Principal exclusion criteria
    - Age <18 years.
    - Performance status> 2 according to the WHO criteria.
    - Patient deprived of liberty or under guardianship, patient with (the) condition (s) psychological, family, social or geographic may interfere with the proper conduct of the study.
    - Diagnosis of a second malignancy in the past 5 years, with the exception of a basal cell skin cancer considered cured.
    - Patient with brain metastases at initial assessment.
    - Patient with another pathology deemed incompatible with the inclusion in the protocol.
    - Laboratory tests inadequate.
    - History of malabsorption syndrome or extensive resection of the upper digestive tract.
    - Uncontrolled intercurrent infection.
    - Pathology autoimmune and / or chronic active inflammation.
    -  peripheral neuropathy grade 2 according to the criteria of the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE, version 4.0).
    - History of allergy to polysorbate 80.
    - Treatment with nonsteroidal anti-inflammatory and / or cyclooxygenase-2 dated within three weeks.
    - Concomitant with a drug test or participation in another clinical trial within <30 days treatment.
    - Regular Taking dietary supplements.
    - Age < 18 ans.
    - Performance status > 2 selon les critères de l’OMS.
    - Patient privé de liberté ou sous tutelle, patient présentant une (des) condition(s) psychologique, familiale, sociale ou géographique pouvant gêner le bon déroulement de l’étude.
    - Diagnostic d’une seconde affection maligne au cours des 5 dernières années, exception faite d’un cancer basocellulaire cutané considéré comme guéri.
    - Patient présentant de métastases cérébrales au bilan initial.
    - Patient présentant une autre pathologie jugée comme incompatible avec l’inclusion dans le protocole.
    - Bilan biologique inadéquat.
    - Antécédents de syndrome de malabsorption ou de résection étendue du tractus digestif supérieur.
    - Infection intercurrente non contrôlée.
    - Pathologie auto-immune et/ou inflammation chronique active.
    - Neuropathie périphérique  grade 2 selon les critères du National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE, version 4.0).
    - Antécédents d’allergie au Polysorbate 80.
    - Traitement par anti-inflammatoires non stéroïdiens et/ou inhibiteurs de la cyclooxygénase-2 datant de moins 3 semaines.
    - Traitement concomitant par un médicament en essai ou participation à un autre essai clinique dans un délai < 30 jours.
    - Prise régulière de compléments alimentaires.
    E.5 End points
    E.5.1Primary end point(s)
    - Evaluation of time to progression
    Time to progression was assessed by the time elapsed between the first day of treatment in the trial and when the disease progresses objectively regardless of initial response to treatment ..
    - Évaluation du temps jusqu’à progression
    Le temps jusqu’à progression est apprécié par le temps écoulé entre le premier jour de traitement dans l’essai et le moment où la maladie progresse objectivement quelle que soit la réponse initiale au traitement..
    E.5.1.1Timepoint(s) of evaluation of this end point
    Monitoring to assess the time to PSA progression will be monthly for one year and then every 3 months for 2 years and then every 6 months.
    Monitoring to assess time to progression (of) lesion (s) tumor (s) will be measured by an assessment visit to 3, 6, 9 and 12 months after the sixth treatment (the paraclinical evaluation will be at the discretion of the investigator after progression).
    Le suivi pour évaluer le temps jusqu’à progression du PSA se fera mensuellement pendant 1 an puis tous les 3 mois pendant 2 ans et enfin tous les 6 mois.
    Le suivi pour évaluer le temps jusqu’à progression de la (des) lésion(s) tumorale(s) mesurables se fera par une visite d’évaluation à 3, 6, 9 et 12 mois après la 6ème cure (l’évaluation paraclinique sera au choix de l’investigateur après la progression).
    E.5.2Secondary end point(s)
    Tumor response to target and non-target lesions
    The biological response will be evaluated on the evolution of PSA
    overall survival
    neuroendocrine markers
    tolerance
    Compliance
    Réponse tumorale sur lésions cibles et non cibles
    La réponse biologique sera évaluée sur l’évolution du taux de PSA
    Survie globale
    Marqueurs neuroendocriniens
    Tolérance
    Compliance
    E.5.2.1Timepoint(s) of evaluation of this end point
    Tumor response was assessed by RECIST. The biological response was evaluated according to the PSA response. Neuro endocrine markers are evaluated by measuring the CgA and NSE. Tolerance will be assessed for each treatment and compliance.
    La réponse tumorale est évaluée selon les critères RECIST. La réponse biologique est évaluée selon la réponse PSA. Les marqueurs neuro endocriniens sont évalués par la mesure du CgA et NSE. La tolérance sera évaluée à chaque cure ainsi que la compliance.
    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
    biological markers assessement
    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 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 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 concerned4
    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
    The end of the study is progression after the last patient of the study.
    La fin de l'étude se situe après la progression de la dernière patiente de l'essai.
    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 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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    F.2 Gender
    F.2.1Female No
    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 state100
    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
    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 Decision2013-10-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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