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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   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:2004-002094-23
    Sponsor's Protocol Code Number:EORTC 30021
    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:2004-11-11
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2004-002094-23
    A.3Full title of the trial
    Estudio aleatorizado de fase II de docetaxel (Taxotere) y oblimersén (oligonucleótido antisentido dirigido frente a bcl-2) vs. Taxotere solo en pacientes con cáncer de próstata refractario a la hormonoterapia
    A.4.1Sponsor's protocol code numberEORTC 30021
    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 SponsorEORTC
    B.1.3.4CountryBelgium
    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 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 Information not present in EudraCT
    D.2.1.1.1Trade name Taxotere
    D.2.1.1.2Name of the Marketing Authorisation holderAventis Pharma S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 namedocetaxel
    D.3.2Product code docetaxel
    D.3.4Pharmaceutical form 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 trihydrate
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 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.3.1Product nameGenasense
    D.3.2Product code G3139
    D.3.4Pharmaceutical form 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.3.9.3Other descriptive nameOblimersen
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    Pacientes con cancer de prostata refractario a la hormonoterapia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.0
    E.1.2Level LLT
    E.1.2Classification code 10001186
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Ensayo aleatorizado de fase II para evaluar la toxicidad y la actividad (en términos de respuesta del PSA) de la combinación de docetaxel y oblimersén en el cáncer de próstata refractario a la hormonoterapia.

    El ensayo es de tipo aleatorizado frente al docetaxel solo, que servirá como grupo de referencia para validar adicionalmente la muestra utilizada en el ensayo.
    E.2.2Secondary objectives of the trial
    En este ensayo se evaluarán también el tiempo hasta la progresión, la toxicidad y la supervivencia.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    • Adenocarcinoma de próstata demostrado histológicamente
    • Cáncer de próstata refractario a la hormonoterapia, definido como en progresión bajo el tratamiento hormonal previo con análogos de LH-RH u orquiectomía y antiandrógenos, ya sea de manera conjunta o consecutiva.
    • Enfermedad progresiva, definida como la progresión del PSA, documentada por 2 valores elevados del PSA en comparación con el valor previo de referencia. Las fluctuaciones del PSA se considerarán tal como se define en la sección 7.1.
    • Antes del registro en el estudio, los pacientes deberán haber presentado una elevación continuada del PSA durante como mínimo las 6 semanas siguientes a la suspensión de los antiandrógenos.
    • PSA mayor o igual a 5 ng/ml (hybritech o equivalente) dentro de la 1 semana previa a la aleatorización.
    • No evidencia clínica de metástasis cerebrales.
    • No evidencia de metástasis óseas dolorosas y/o destructivas para las que el médico responsable del paciente considere necesaria la radioterapia, los bifosfonatos o radionúclidos buscadores de hueso. Se permiten las otras metástasis óseas.
    • Edad > 18 años.
    • Estado funcional de la OMS = 0-2 (véase el Apéndice B).
    • No toma regular (diaria) de analgésicos opiáceos.
    • No tratamiento previo con quimioterapia, radionúclidos buscadores de hueso o radioterapia sobre más del 25% del área productora de médula ósea (se permite el uso previo de estramustina fosfato y/o bifosfonatos).
    • No manipulación hormonal previa con el preparado de hierbas medicinales PC-SPES dentro de las 6 últimas semanas antes de la entrada en el estudio.
    • El tratamiento antiandrogénico con flutamida, bicalutamida o nilutamida deberá haberse suspendido como mínimo 6 semanas antes de la aleatorización.
    • No tratamiento concomitante con otros fármacos experimentales o antineoplásicos (excepto un agonista de LH-RH) ni con bifosfonatos.
    • Nivel de testosterona de castración (< 50 ng/ml). Los pacientes sometidos a castración médica con un análogo de LH-RH deberán continuar con dicho análogo.
    • Acceso venoso adecuado
    • Función hematológica adecuada, evaluada por: Hb > 10 g/dl, leucocitos > 3.500 x 109/L, RAN > 1,5 x 109/L y plaquetas >100 x 109/L
    • Función hepática adecuada, evaluada por: bilirrubina < límite superior de la normalidad (LSN) y ASAT < 1,5 x LSN y ALAT < 1,5 x LSN
    • Función renal adecuada, evaluada por creatinina sérica < 1,5 x LSN o aclaramiento de creatinina calculado > 50 ml/min con la fórmula de Cockcroft (véase la fórmula en el Apéndice C)
    • Tiempo de tromboplastina parcial (TTP) < 1,5 x LSN y tiempo de protrombina (TP) < 1,5 x LSN (o INR < 1,3).
    • No hipersensibilidad conocida a los oligonucleótidos o a cualquier componente de la formulación del oblimersén o a los fármacos formulados con polisorbato. No hipersensibilidad a los fosforotioatos.
    • No ACVA o ataque isquémico transitorio o infarto de miocardio dentro de los 6 últimos meses
    • No infección activa, no infección conocida por el VIH
    • No historia de neumonitis intersticial o de fibrosis pulmonar
    • No angina inestable, embolismo pulmonar o hipertensión no controlada
    • No historia de trombosis venosa profunda dentro de los 6 meses previos a la entrada en el estudio
    • No neuropatía preexistente
    • No segundo cáncer primario (excepto el cáncer urotelial superficial o el cáncer cutáneo adecuadamente tratado sin signos de recurrencia en los últimos 5 años)
    • Ausencia de circunstancias psicológicas, familiares, sociológicas o geográficas que pudieran dificultar el cumplimiento con el protocolo del estudio y con el calendario de seguimiento; dichas circunstancias deberán discutirse con el paciente antes de su registro en el ensayo
    • Antes del registro/aleatorización del paciente, este deberá otorgar su consentimiento informado de acuerdo a las directrices de ICH/BPC y las normas nacionales/locales
    Los pacientes sólo se podrán aleatorizar en este ensayo una vez.
    E.4Principal exclusion criteria
    Por favor referirse a los criterios de inclusion indicades arriba
    E.5 End points
    E.5.1Primary end point(s)
    Variables principales:

    1. Respuesta del PSA definida como una disminucion del 50 % en el nivel basal del PSA confirmada por un segundo valor obtenido como minimo 4 semanas despues segun los criterios Bubley.

    2. Suceso de Eventos Tocicos Mayores

    Toda toxicidad hematologica o no hematologica de grado 4, excepto la neutropenia asintomatica de grado 4 (RAN < 500/mm3) de duracion inferior a 7 dias

    Neutropenia febril de grado 3 durante > 5 dias o cualquier neutropenia febril de grado 4.

    Sepsis (de grado 3 o 4)

    Hemorragia- sangrado severo (grado 3 o 4) junto con trombocitopenia de grado > 2 (< 50.000/mm3)

    Toxicidad renal de grado 3 o 4 (creatinina sercia > 3 X LSN o necesidad de dialisis)

    Suspension del tratamiento por toxicidad inaceptable

    Muerte debida al menos posiblemente a toxicidad.
    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 Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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
    El final de estudio sucede cuando se cumplen todos los criterios siguientes:

    1) 30 dias despues de que todos los pacientes hayan terminado el tratamiento.
    2) El ensayo esta listo para el analisis de la variable principal definida segun protocolo.
    3) La base de datos esta comletamente limpia y congelada para analisis

    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 170
    F.4.2.2In the whole clinical trial 210
    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)
    Not different from the expected normal treatment
    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 Decision2004-12-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-05-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-09-29
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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