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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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:2008-001825-32
    Sponsor's Protocol Code Number:TTD-08-02
    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:2008-05-07
    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 number2008-001825-32
    A.3Full title of the trial
    "Fase II Docetaxel-Oxiplatino-Capecitabina (DOX) a dosis ajustadas en pacientes con adenocarcinoma gástrico avanzado y estado general subóptimo"
    A.3.2Name or abbreviated title of the trial where available
    MiniDOX
    A.4.1Sponsor's protocol code numberTTD-08-02
    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 SponsorGrupo de Tratamiento de los Tumores Digestivos (TTD)
    B.1.3.4CountrySpain
    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 Yes
    D.2.1.1.1Trade name Eloxatin
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI-AVENTIS, S. A.
    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 nameEloxatin
    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 INNOxaliplatino
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10ml/50mg to 20ml/100mg
    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 Yes
    D.2.1.1.1Trade name Xeloda
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE REGISTRATION LIMITED
    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 nameXeloda
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNCapecitabina
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150 to 500
    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 Yes
    D.2.1.1.1Trade name Taxotere
    D.2.1.1.2Name of the Marketing Authorisation holderDocetaxel 40 mg/m2 EU/1/95/002/002
    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 nameTaxotere
    D.3.4Pharmaceutical form Solution for injection
    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.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5ml/20mg to 2ml/80mg
    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
    Pacientes diagnosticados histológicamente de adenocarcinoma gástrico o de la unión esófago gástrica (tipos I, II y III de Siewert) localmente avanzado irresecable, metastásico o recidivado.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10017758
    E.1.2Term Gastric cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determinar la tasa de respuesta objetiva de la combinación de Docetaxel, Oxaliplatino y Capecitabina (DOX) en pacientes con cáncer gástrico avanzado no susceptibles de tratamiento radical.
    E.2.2Secondary objectives of the trial
    - Tasa de control de la Enfermedad (Respuesta completa, Respuesta parcial o Estabilización)
    - Toxicidad de DOX
    - Intensidad de dosis finalmente administrada
    - Supervivencia libre de progresión
    - Supervivencia global
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Consentimiento informado por escrito.
    2. Pacientes diagnosticados histológicamente de Adenocarcinoma gástrico o de la unión esófago gástrica (tipos I, II y III se Siewert), localmente avanzado irresecable, metastásico o recidivado.
    3.Enfermedad medible (criterios RECIST). Se consideran medibles las imágenes de metástasis o recidivas locoregionales si su diámetro es ≥ 1 cm en TAC helicoidal o ≥ 2 cm en TAC convencional. El tumor primario no se admitirá como lesión medible. Si serán admisibles como lesiones medibles las adenopatías regionales pero sólo si son ≥ 2 cm.
    4.Edad mayor de 18 años.
    5. Al menos una de las características siguientes:
    - Performance status (ECOG) igual a 2
    - Pérdida ponderal entre el 10% y el 25% en los últimos 3 meses
    - Edad igual o mayor de 70 años
    6. Expectativa de vida igual o superior a 12 semanas
    7. Adecuada función hematológica:
    - Recuento absoluto de neutrófilos ≥ de 1.5 x 10 9/L
    - Recuento de plaquetas ≥ 100 x 10 9 /L
    8. Adecuada coagulación: INR ≤ 1.5 o A. Protrombina > 70 %
    9. Adecuada función hepática
    10. Adecuada función renal
    11. Ingesta oral adecuada
    12. Función cardiaca normal, sin signos o síntomas de insuficiencia cardiaca o cardiopatía isquémica en los 6 meses previos. FE > 50% en caso de dudas.
    13. Todas las mujeres en edad fértil deberán presentar una prueba negativa de embarazo en suero u orina (sensibilidad mín 25 UI/L de BHCG) dentro de las 2 semanas previas a la inclusión.
    14. Los pacientes en edad fértil deberán seguir un método anticonceptivo eficaz durante todo el tratamiento.
    15. Los pacientes deberán ser tratados y estudiados en el centro participante
    16. Los pacientes deberán ser accesibles para el tratamiento y seguimiento implicando esto la imposición de unos límites geográficos razonables. Deberán ser capaces de adherirse al protocolo durante toda la duración del mismo.
    E.4Principal exclusion criteria
    1. Lesión no medible como única evidencia de enfermedad
    2. Haber recibido tratamiento quimioterápico previo para la enfermedad avanzada. No sería criterio de exclusión el haber recibido quicio o radioterapia para la enfermedad localizada con anterioridad siempre que dicho tratamiento se hubiese completado hace más de 1 año, y en caso de única enfermedad medible dentro de un área previamente radiada, se hubiese documentado progresión de esa lesión antes de la inclusión.
    3. Otras neoplasias diagnosticadas en los cinco años anteriores, excepto carcinomas espinocelulares o basocelulares de la piel y carcinoma in situ de cerviz tratado adecuadamente.
    4. Hipersensibilidad conocida a Docetaxel, Oxaliplatino o Capecitabina
    5. Evidencia de metástasis en el sistema nervioso central (CNS). Pacientes con historial de ataques incontrolados, desórdenes del sistema nervioso central o discapacidad psiquiátrica que a juicio del investigador tengan relevancia clínica que impida el consentimiento informado o interfiera con el cumplimiento del tratamiento.
    6. Antecedentes de reacciones graves o inesperadas al tratamiento con fluopirimidinas y/o pacientes con una probada deficiencia de dehidropirimidina deshidrogenasa (DPD).
    7. Pacientes con PS superior a 2 o con pérdida ponderal superior al 25% en los últimos 3 meses.
    8. . Pacientes catalogados como delicados o frágiles para cumplir cualquiera de los siguientes criterios:
    - Dependencia en 1 ó más de las actividades de la vida diaria según escala formal de actividades de la vida diaria (AVD de Katz)
    - Tres o más entidades comorbidas mediante la evaluación de la presencia de los siguientes procesos: insuficiencia cardiaca congestiva, valvulopatía cardiaca, coronariopatía, enfermedad pulmonar crónica (obstructiva o restrictiva), enfermedad cerebro vascular, neuropatías periféricas, insuficiencia renal crónica, hipertensión, diabetes, neoplasias concomitantes, enfermedades vasculares del colágeno, hepatopatía crónica y artritis incapacitante.
    - Presencia de síndromes geriátricos: demencia moderada – severa, delirios en situación de estrés (infección urinaria o respiratoria, angina o fármacos), depresión moderada – severa que interfiere con la actividad habitual del paciente; caídas frecuentes; desatención; incontinencia urinaria en ausencia de estrés, infección, diuréticos o hiperplasia prostática; incontinencia fecal en ausencia de diarrea o laxantes; fracturas osteoparóticos de huesos largos o aplastamientos vertebrales
    9. Presencia de enfermedad cardiaca concomitante:
    - Historia de arritmias aurículoventriculares sintomáticas y/o
    - Insuficiencia cardiaca congestiva no controlada médicamente y/o
    - Infarto de miocardio los 12 meses previos al reclutamiento y/o
    - Cardiopatía isquémica sintomática.
    10. Presencia de proceso infeccioso activo. Si leucocitosis superior a 12x109/L ó fiebre superior a 38ºC, se requiere RX tórax, hemocultivo y urocultivo negativo en los 5 días previos a la inclusión.
    11. Proceso médico subyacente grave que pudiese menoscabar la capacidad del paciente para recibir el tratamiento del Protocolo
    12. Enfermedades concomitantes severas o mal controladas
    13. Cualquier otra condición o terapia que a criterio del IP o por indicación del prospecto pueda suponer algún riesgo para el paciente o interferir con los objetivos del estudio.
    14. Tratamiento con cualquier otro fármaco en investigación no comercializado en los 30 días anteriores al inicio de tratamiento
    E.5 End points
    E.5.1Primary end point(s)
    1. Tasa de respuestas objetivas según criterios RECIST
    2. Valoración de la tasa de control de la enfermedad
    3. Toxicidad del tratamiento
    4. Intensidad de dosis administrada
    5. Supervivencia libre de progresión
    6. Supervivencia global
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned10
    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 Information not present in EudraCT
    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
    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 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 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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-05-07. Yes
    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 state40
    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 Decision2008-07-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-13
    P. End of Trial
    P.End of Trial StatusCompleted
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