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    Summary
    EudraCT Number:2010-022064-12
    Sponsor's Protocol Code Number:EFC11784
    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:2011-02-18
    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 number2010-022064-12
    A.3Full title of the trial
    Estudio aleatorizado, abierto y multicéntrico de comparación de cabazitaxel a dosis de 25 mg/m2 y 20 mg/m2, administrado en combinación con prednisona cada 3 semanas, con docetaxel administrado en combinación con prednisona en pacientes con cáncer de próstata metastásico hormonorresistente que no han recibido tratamiento previo con quimioterapia_____________________________________Randomized, Open Label, Multi-Center Study comparing Cabazitaxel at 25 mg/m2 and at 20 mg/m² in Combination with Prednisone Every 3 Weeks to Docetaxel in Combination with Prednisone in Patients with Metastatic Castration Resistant Prostate Cancer not Pretreated with Chemotherapy
    A.3.2Name or abbreviated title of the trial where available
    FIRSTANA
    A.4.1Sponsor's protocol code numberEFC11784
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of Sponsorsanofi-aventis R&D
    B.1.3.4CountryFrance
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 JEVTANA
    D.2.1.1.2Name of the Marketing Authorisation holdersanofi-aventis US Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 namecabazitaxel
    D.3.2Product code XRP6258
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeXRP6258
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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.IMP: 2
    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 namecabazitaxel
    D.3.2Product code XRP6258
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeXRP6258
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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.IMP: 3
    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 Information not present in EudraCT
    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.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDOCETAXEL
    D.3.9.1CAS number 114977-28-5
    D.3.9.3Other descriptive nameDOCETAXEL
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    cáncer de próstata metastásico hormonorresistente__________________
    metastatic Castration Resistant Prostate cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10060862
    E.1.2Term Prostate cancer
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level PT
    E.1.2Classification code 10060862
    E.1.2Term Prostate cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Demostrar la superioridad de cabazitaxel más prednisona a una dosis de 25 mg/m2 (Grupo A) o de 20 mg/m2 (Grupo B) frente a docetaxel más prednisona (Grupo C) en cuanto a supervivencia global (SG) en pacientes con cáncer de próstata metastásico hormonorresistente (CPMHR) no tratados previamente con quimioterapia.
    E.2.2Secondary objectives of the trial
    1.Evaluar la seguridad en los 3 grupos de tratamiento.2.Comparar la eficacia de cabazitaxel a una dosis de 20 mg/m2 y de 25 mg/m2 con docetaxel en lo que respecta a los siguientes aspectos:Supervivencia libre de progresión (SLP), definida como la aparición de cualquiera de los acontecimientos siguientes:progresión tumoral según los criterios de evaluación de la respuesta en tumores sólidos (RECIST 1.1), progresión del PSA, progresión del dolor o muerte por cualquier causa,SLP, definida como la aparición de cualquiera de los acontecimientos siguientes:progresión tumoral según los criterios de evaluación de la respuesta en tumores sólidos (RECIST 1.1) o muerte por cualquier causa,Respuesta tumoral en pacientes con enfermedad medible (RECIST 1.1),Respuesta del PSA- SLP del PSA, SLP del dolor- Tiempo hasta la aparición de cualquier evento óseo (EO).3. Comparar la calidad de vida relacionada con la salud (CVRS).4. Evaluar las propiedades farmacocinéticas de cabazitaxel.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    I 01. Adenocarcinoma de próstata confirmado histológica o citológicamente.
    I 02. Enfermedad metastásica.
    I 03. Enfermedad progresiva (EP) mientras se recibe tratamiento
    hormonal o después de la castración quirúrgica confirmada.
    I 04. Castración efectiva (concentraciones de testosterona sérica inf o igual a 0,50
    ng/dl) mediante orquiectomía y/o agonistas de la LHRH con o sin antiandrógenos.
    E.4Principal exclusion criteria
    Relacionados con la metodología:
    E01. Haber recibido previamente quimioterapia para el cáncer de próstata, excepto estramustina y excepto tratamiento adyuvante o neoadyuvante completado hace superior a 3 años. La inmunoterapia previa con sipuleucel-T está permitida siempre que el paciente no haya recibido quimioterapia previa.
    E02. Haber transcurrido menos de 28 días desde el tratamiento previo con estramustina, radioterapia o cirugía hasta el momento de la aleatorización. Los pacientes pueden estar recibiendo bisfosfonatos antes de su inclusión en el estudio.
    E03. Tratamiento previo con isótopos, radioterapia pélvica entera o radioterapia hasta superior a 30% de la médula ósea.
    E04. Acontecimientos adversos (excluyendo alopecia y los enumerados en los criterios de exclusión específicos) derivados de cualquier tratamiento antineoplásico previo, de grado superior a 1 (según los criterios terminológicos comunes Common Terminology Criteria del National Cancer Institute, NCI CTCAE, v. 4.03) en el momento de la aleatorización.
    E05. Ser menor de 18 años.
    E06. Estado funcional según el ECOG (Eastern Cooperative Oncology Group) superior a 2.
    E07. Tener antecedentes de metástasis cerebrales, compresión de la médula espinal no controlada o meningitis carcinomatosa, o signos nuevos de enfermedad cerebral o leptomeníngea.
    E08. Haber padecido una neoplasia maligna previa. Se permiten antecedentes de cáncer de piel basocelular o epidermoide o de cáncer de vejiga superficial (pTis, pTa y pT1) tratados adecuadamente, así como cualquier otro cáncer para el que la quimioterapia se haya completado hace superior o igual a 5 años y del que el paciente se haya mantenido libre durante superior o igual a 5 años.
    E09. Haber participado en otro estudio clínico y haber recibido cualquier otro tratamiento concurrente con cualquier fármaco en fase de investigación en los 30 días previos a la aleatorización.
    E10. Haber presentado cualquiera de los procesos siguientes en los 6 meses previos a la inclusión en el estudio: infarto de miocardio, angina de pecho grave/inestable, cirugía de bypass aortocoronario/periférico, insuficiencia cardíaca congestiva de clase III o IV según la NYHA, ictus o accidente isquémico transitorio.
    E11. Haber presentado cualquiera de los procesos siguientes en los 3 meses previos a la aleatorización: úlcera péptica resistente al tratamiento, esofagitis o gastritis erosiva, enfermedad intestinal infecciosa o inflamatoria, diverticulitis, embolia pulmonar o cualquier episodio tromboembólico no controlado.
    E12. Padecer síndrome de inmunodeficiencia adquirida (enfermedades relacionadas con el SIDA) o enfermedad por VIH conocida que requiera tratamiento antirretroviral.
    E13. Padecer otras enfermedades graves agudas o crónicas que pudieran dificultar la capacidad del paciente para participar en el estudio o interferir en la interpretación de los resultados del estudio o impedir que el paciente pudiera cumplir los procedimientos del estudio.
    E14. No haber firmado y fechado el formulario de consentimiento informado aprobado por el Comité Ético de Investigación Clínica (CEIC) antes de la inclusión en el estudio.
    E15. Los pacientes con capacidad reproductora que no acepten la utilización de un método anticonceptivo eficaz y aceptado durante el periodo de tratamiento del estudio. La definición de "método anticonceptivo eficaz" se basará en el criterio del investigador.
    En cuanto a los pacientes incluidos en el Reino Unido, su pareja (a menos que sea estéril por métodos quirúrgicos, posmenopáusica o que, por cualquier otra razón, no pueda quedarse embarazada) deberá usar un medio anticonceptivo eficaz de los descritos a continuación: anticonceptivos orales o dispositivo intrauterino.
    Relacionados con la quimioterapia
    E16. Antecedentes de hipersensibilidad a docetaxel o a polisorbato 80.
    E17. Disfunción orgánica y medular confirmada mediante:
    a. Hemoglobina inferior a 10,0 g/dl
    b. Recuento absoluto de neutrófilos inferior a 1,5 x 109/l
    c. Trombocitos inferior a 100 x 109/l
    d. ASAT/SGOT y/o ALAT/SGPT superior a 1,5 x LSN
    e. Bilirrubina total superior a 1,0 x LSN
    f. Creatinina sérica superior a 1,5 x LSN. Si el valor de la creatinina sérica está comprendido entre 1,0 y 1,5 x LSN, el aclaramiento de creatinina se calculará mediante la fórmula de Cockcroft-Gault para los pacientes menores de 65 años y según la versión abreviada de la fórmula del estudio de modificación de la dieta en la enfermedad renal Abbreviated Modification of Diet in Renal Disease (aMDRD) para los pacientes superior o igual a 65 años. Un valor de aclaramiento de creatinina inferior a 60 ml/min excluirá al paciente (véase el Anexo A para obtener información sobre la fórmula para el cálculo).
    E18. Contraindicaciones al uso de corticoesteroides.
    E19. Neuropatía periférica sintomática de grado superior a 2 (National Cancer
    Institute Common Terminology Criteria NCI CTCAE v.4.03)
    E.5 End points
    E.5.1Primary end point(s)
    La SG, definida como el intervalo transcurrido desde la fecha de aleatorización hasta la fecha de la muerte por cualquier causa.
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 EEA54
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    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 maximum study duration and the final study cut-off date for survival will be the date when approximately 774 deaths have occurred or approximately 516 deaths if one of the cabazitaxel arm is prematurely stopped.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months0
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 442
    F.4.2.2In the whole clinical trial 1170
    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 Decision2011-04-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-05-23
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