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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:2008-004223-27
    Sponsor's Protocol Code Number:GEMCAD-0802
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2008-09-23
    Trial 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 number2008-004223-27
    A.3Full title of the trial
    Estudio fase II, de la combinación de Oxaliplatino y Sorafenib en pacientes con Adenocarcinoma gástrico o de la unión gastroesofágica localmente avanzado o metastásico, en progresión tras un esquema basado en cisplatino.
    A.4.1Sponsor's protocol code numberGEMCAD-0802
    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 SponsorGEMCAD
    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 Nexavar 200 mg comprimidos recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderBayer HealthCare AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameSORAFENIB
    D.3.2Product code BAY 43-9006
    D.3.4Pharmaceutical form Coated 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 INNSORAFENIB
    D.3.9.1CAS number 284461-73-0
    D.3.9.2Current sponsor codeBAY 43-9006
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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) Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeINHIBIDOR MULTIKINASA
    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 nameOXALIPLATINO
    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 INNOXALIPLATINO
    D.3.9.1CAS number 61825-94-3
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number130
    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) Information not present in EudraCT
    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
    CANCER GASTRICO
    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 eficacia de tratamiento
    E.2.2Secondary objectives of the trial
    ?Toxicidad
    ?Supervivencia
    ?Calidad de Vida
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adenocarcinoma gástrico o de la unión demostrado por citología o biopsia, con enfermedad irresecable o metástasica que hayan progresado a un esquema basado en cisplatino-5Fluorouracilo (excluído si el esquema se administró de manera neoadyuvante con o sin radioterapia concomitante)
    2. Ser mayores de 18 años en el momento de firmar el consentimiento.
    3. Edad > 18 años
    4. ECOG 0-2
    5. Enfermedad medible por criterios RECIST. Las lesiones deben ser medidas por CT o RMN
    6. Esperanza de vida superior a 12 semanas.
    7. Adecuada reserva medular y función hepática y renal, definida según los siguientes parámetros:
    a. Hemoglobin ? 9g/dl
    b. Neutrófilos ? 1,5 x 109/L
    c. Plaquetas ?100 x 109/L
    d. Bilirrubina total ? a 1.5 veces el límite superior de la normalidad (ULN).
    e. ALT(GPT) y AST (GOT) ? a 2.5 veces el límite superior de la normalidad (ULN). (? a 5 veces ULN en pacientes con metástasis hepáticas).
    f. PT-INRPTT ? a 1.5 veces UPN. (Los pacientes en tratamiento anticoagulante con dicumarínicos o heparina, podrán ser incluíbles si no existe evidencia previa de alteración de estos parámetros antes del inicio del tratamiento anticoagulante).
    g. Aclaramiento de creatinina superior a 30 ml/ml
    8. Los pacientes deben ser capaces de comprender el significado de su participación en el ensayo y otorgar voluntariamente su consentimiento para participar firmando el documento de consentimiento informado.
    E.4Principal exclusion criteria
    1. Haber recibido más de una primera línea para enfermedad localmente avanzada
    2. Cardiopatía isquemica activa. Historia de enfermedad cardiaca definida por :
    a. Insuficiencia cardiaca congestiva > clase 2 d la NYHA
    b. Enfermedad coronaria activa. Se permite el reclutamiento de pacientes con infarto agudo de miocardio resuelto, diagnosticado al menos 6 meses antes del inicio del estudio).
    c. Arritimia cardiaca que requiere tratamiento con fármacos antiarrítmicos; (Se permite el tratamiento con fármacos beta-bloqueantes o digoxina).
    d. Hipertensión arterial no controlada.
    3. Enfermedad intercurrente no controlada
    4. Neuropatía periférica sensitiva sintomática
    5. Otra enfermedad maligna diagnosticada en los últimos 5 años, excepto el carcinoma de cérvix in situ adecuadamente tratado, carcinoma de piel no melanoma, tumor de vejiga superficial (Ta, Tis y T1), o cualquier tumor tratado de manera curativa nates de los 3 años del reclutamiento.
    6. Mujer embarazada o en período de lactancia. Las mujeres deberán someterse a un test de embarazo en los 7 días previos al reclutamiento. Tanto los hombres como mujeres reclutados en el ensayo, deberán utilizar un método anticonceptivo de barrera adecuado en sus relaciones sexuales, durante el periodo del ensayo y hasta al menos dos semansa tras la finalización el mismo. Los hombres que participen en el ensayo, deberán continuar con este tipo de método anticonceptivo al menos hasta 3 meses tras la finalización del tratamiento.
    7. Infección crónica conocida por VIH, Hepatitis B, y /o Hepatitis C.
    8. Infección severa clínicamente activa ( grado 2 NCI-CTC version 3.0).
    9. Metástasis cerebrales o tumor meníngeo.
    10. Pacientes que requieran tratamiento crónico corticoideo o altas dosis de corticoesteroirdes o cualquier otro tratamiento inmunosupresor
    11. Pacientes sometidos a cirugía mayor < 4 semanas del inicio del estudio
    12. Pacientes que hayan finalizado tratamiento de quimioterapia o radioterapia hace < 4 semanas ( a excepción de radioterapia paliativa antialgica en que se permitiran 2 semanas de intervalo)
    13. Haber realizado tratamiento previo con un inhibidor de la vía de Ras.
    14. Pacientes con diátesis hemorrágica.
    15. Cualquier condición médica, psiquiátrica grave o consumo de drogas, que implique para el paciente un serio riesgo derivado de su participación en el ensayo, o que le pueda impedir la firma del consentimiento informado
    16. Pacientes que no son capaces de tragar medicación.
    E.5 End points
    E.5.1Primary end point(s)
    ? Supervivencia libre de progresión (PFS).
    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 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) 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 concerned11
    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 years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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 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 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 state46
    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 Decision2008-10-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-09-15
    P. End of Trial
    P.End of Trial StatusOngoing
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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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