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    Summary
    EudraCT Number:2011-002570-23
    Sponsor's Protocol Code Number:CAUY922A2205
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-10-05
    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 number2011-002570-23
    A.3Full title of the trial
    Estudio fase II, multicéntrico, abierto, con un grupo de tratamiento, para evaluar la eficacia y la seguridad de AUY922 en combinación con la terapia estándar, trastuzumab, como tratamiento de segunda línea en pacientes con cáncer gástrico avanzado HER2 positivo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Estudio fase II, multicéntrico, abierto, con un grupo de tratamiento, para evaluar la eficacia y la seguridad de AUY922 en combinación con la terapia estándar, trastuzumab, como tratamiento de segunda línea en pacientes con cáncer gástrico avanzado HER2 positivo
    A.4.1Sponsor's protocol code numberCAUY922A2205
    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 SponsorNovartis Farmaceutica S.A.
    B.1.3.4CountrySpain
    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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmaceutica S.A.
    B.5.2Functional name of contact pointJavier Malpesa
    B.5.3 Address:
    B.5.3.1Street AddressGran Via de las Cortes Catalanas 764, 2ª planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number0034933064464
    B.5.5Fax number0034933064290
    B.5.6E-maileecc.novartis@novartis.com
    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.3.2Product code AUY922
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 747412-49-3
    D.3.9.2Current sponsor codeAUY922
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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) 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 No
    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.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 Herceptin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited, UK
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameTrastuzumab
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 INNTRASTUZUMAB
    D.3.9.1CAS number 180288-69-1
    D.3.9.4EV Substance CodeSUB12612MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 No
    D.3.11.9Recombinant medicinal product Yes
    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 cáncer gástrico avanzado HER2 positivo documentado, que progresen después de observarse beneficio clínico con el tratamiento de 1ª línea con un tratamiento que contenga trastuzumab. El beneficio clínico se define como respuesta global o enfermedad estable de por lo menos 12 semanas de duración, desde el inicio de la terapia de 1ª línea con trastuzumab según RECIST.
    E.1.1.1Medical condition in easily understood language
    Patients with advanced HER2 positive gastric cancer who have progressed after benefiting from a Trastuzumab containg treatement
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10066896
    E.1.2Term HER-2 positive gastric cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10063916
    E.1.2Term Metastatic gastric cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    ? Evaluar la eficacia preliminar de AUY922 en combinación con la terapia estándar con trastuzumab, utilizando la tasa de respuesta global (TRG), según el investigador, en pacientes con cáncer gástrico HER2+ avanzado que progresan con el tratamiento de 1ª línea que contenga trastuzumab.
    E.2.2Secondary objectives of the trial
    - To estimate Progression Free Survival (PFS)
    ? Calcular la supervivencia libre de progresión (SLP)
    ? Calcular la supervivencia global (SG)
    ? Calcular la tasa de control de la enfermedad (TCE)
    ? Evaluar la seguridad y la tolerabilidad de AUY922 cuando se administra en combinación con terapia estándar con trastuzumab.
    ? Caracterizar el perfil farmacocinético de AUY922 cuando se administra en combinación con terapia estándar con trastuzumab.
    ? Evaluar el efecto farmacodinámico de AUY922 en combinación con terapia estándar con trastuzumab en proteínas cliente de HSP90 (HER2) en tejido de tumor (cuando se disponga de biopsias) y sangre.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Pacientes con adenocarcinoma gástrico o adenocarcinoma de la unión gastroesofágica confirmados histológicamente o documentados citológicamente y HER2 positivo demostrado.
    *Pacientes con enfermedad progresiva (confirmación radiológica necesaria según RECIST) después del tratamiento de primera línea de trastuzumab en combinación con quimioterapia para el cáncer gástrico avanzado.
    * Tumor gástrico positivo que sobreexprese HER2 con IHC3+ o IHC2+ con hibridización in situ positiva.
    * Enfermedad medible según RECIST (las lesiones irradiadas no pueden considerarse medibles excepto que hayan progresado claramente desde la radioterapia).
    Criterios específicos del estudio (para una lista completa de los criterios de inclusión para participar en el estudio, por favor, remítase al Apartado 5.2)
    E.4Principal exclusion criteria
    Evidencia de compresión de la médula espinal o evidencia actual de metástasis del SNC. La TC/RM del cerebro es obligatoria (dentro de las 3 semanas antes del inicio del estudio) en el caso de sospecha clínica o de evidencia de metástasis cerebrales.
    * Pacientes en los cuales el último tratamiento con quimioterapia o tratamiento con otro agente antineoplásico sistémico haya sido administrado < 4 semanas antes. Los pacientes deberán haberse recuperado (CTC ? 1) de las toxicidades agudas de cualquier terapia previa (con la excepción de alopecia).
    * Tratamiento previo con un agente que actúe vía HER2/c-erbB2 excepto trastuzumab de 1ª línea, incluyendo (pero no limitado a) lapatinib y pertuzumab.
    * Pacientes con ascitis maligna que precise tratamiento invasivo
    * Mujeres físicamente fértiles (WOCBP) que no utilicen métodos anticonceptivos adecuados (abstinencia, anticonceptivos orales, dispositivo intrauterino o método anticonceptivo de barrera junto con gel espermicida o quirúrgicamente estériles). Las mujeres físicamente fértiles (WOCBP), definidas como todas las mujeres fisiológicamente capaces de quedarse embarazadas, deberán utilizar métodos anticonceptivos eficaces durante el estudio y durante 5 T1/2 después de suspender el tratamiento.
    El método anticonceptivo altamente eficaz se define como:
    ? Abstinencia total: Cuando esto esté en consonancia con el estilo de vida habitual y preferido de la paciente. [Abstinencia periódica (por ejemplo, método del calendario, ovulación, método sintotérmico, método de postovulación) y el método de retirada no son métodos anticonceptivos aceptables].
    ? Esterilización: pacientes sometidas a ooforectomía bilateral quirúrgica (con o sin histerectomía) o ligadura de trompas por lo menos seis meses antes de tomar el tratamiento del estudio. En el caso de ooforectomía sola, esto sólo es aplicable cuando el estado reproductor de la mujer haya sido confirmado con evaluación de seguimiento del nivel hormonal.
    ? Esterilización de la pareja varón (con la documentación apropiada post-vasectomía de la ausencia de espermatozoides al eyacular). [Para las pacientes mujeres del estudio, el varón vasectomizado debería ser la única pareja de dicha paciente].
    ? Uso de una combinación de alguno de los dos métodos siguientes (a+b o a+c o b+c):
    a. Uso de métodos anticonceptivos orales, inyectados u hormonales implantados
    b. Colocación de un dispositivo intrauterino (DIU) o de sistema intrauterino (SIU)
    c. Métodos anticonceptivos de barrera: preservativo o capuchón oclusivo (diafragma o capuchón cervical/en bóveda) con supositorio vaginal/crema/película/gel/espuma epermicida
    ? En el caso de uso de anticonceptivos femeninos orales, estos deberán haberse mantenido estables con la misma píldora durante un mínimo de 3 meses antes de tomar el tratamiento del estudio.
    Criterios específicos del estudio (para una lista completa de los criterios de inclusión para participar en el estudio, por favor, remítase al Apartado 5.2)
    E.5 End points
    E.5.1Primary end point(s)
    TRG según RECIST
    E.5.1.1Timepoint(s) of evaluation of this end point
    cada seis semanas
    E.5.2Secondary end point(s)
    SLP según RECIST
    SG
    TCE según RECIST
    Reacciones farmacológicas adversas, cambios en los valores bioquímicos y hematológicos, específicamente aquellos asociados con la función hepática y renal; evaluación de las exploraciones físicas, exámenes oculares, exámenes neurológicos y electrocardiogramas.
    Exposición de AUY922 y de BJP762 en plasma (evaluado con parámetros como el AUC0-t, Cmax, T1/2, Tmax, Cvalle)
    Cambio pretratamiento frente a postratamiento en serie en los niveles de biomarcadores solubles (sangre) y cambio pre frente a postratamiento en la puntuación H de HER2 (tejido)
    E.5.2.1Timepoint(s) of evaluation of this end point
    at the protocol defined timepoints (PFS, DCR, PK) or throughout th etratment period (safety, survival)
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 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 No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    France
    Germany
    Italy
    Japan
    Korea, Republic of
    Netherlands
    Spain
    United States
    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 study is defined as the time when the last patient completes the survival follow up information.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months11
    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 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: 24
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    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 No
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 48
    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)
    Ver Protocolo
    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 Decision2011-11-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-05-29
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