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    Summary
    EudraCT Number:2010-023183-40
    Sponsor's Protocol Code Number:CSOM230I2201
    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:2011-06-13
    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 number2010-023183-40
    A.3Full title of the trial
    Estudio de fase II, multicéntrico, aleatorizado, abierto que evalúa la eficacia de everolimus oral solo o en combinación con pasireotida LAR i.m. en tumores neuroendocrinos pancreáticos (TNEP) progresivos en estadio avanzado - Estudio COOPERATE-2
    A.4.1Sponsor's protocol code numberCSOM230I2201
    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 SponsorNovartis Farmacéutica 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 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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/04/200
    D.3 Description of the IMP
    D.3.1Product namepasireotide
    D.3.2Product code SOM230
    D.3.4Pharmaceutical form Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPasireotide
    D.3.9.2Current sponsor codeSOM230
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPasireotide
    D.3.9.2Current sponsor codeSOM230
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 Yes
    D.2.1.1.1Trade name AFINITOR 5 mg comprimidos
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS EUROPHARM LTD.
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/07/488
    D.3 Description of the IMP
    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 INNEVEROLIMUS
    D.3.9.3Other descriptive nameEVEROLIMUS
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) 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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/04/200
    D.3 Description of the IMP
    D.3.1Product namepasireotide
    D.3.2Product code SOM230
    D.3.4Pharmaceutical form Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNpasireotide
    D.3.9.2Current sponsor codeSOM230
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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.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
    tumores neuroendocrinos pancreáticos (TNEP) progresivos en estadio avanzado
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level PT
    E.1.2Classification code 10067517
    E.1.2Term Pancreatic neuroendocrine tumour
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Estimar el efecto del tratamiento de everolimus en combinación con pasireotida LAR con respecto al efecto de everolimus solo sobre la supervivencia libre de progresión (SLP) en pacientes con TNEP en estadio avanzado y determinar la probabilidad predictiva de éxito en un posible estudio de fase III posterior cuando se hayan observado 80 sucesos de SLP.
    E.2.2Secondary objectives of the trial
    - Evaluar el perfil de seguridad y tolerabilidad de everolimus solo o en combinación con pasireotida LAR.
    - Evaluar la tasa de respuesta objetiva (TRO) y la tasa de control de la enfermedad (TCE)
    - Evaluar la duración de la respuesta (DR)
    - Evaluar la supervivencia global (SG)
    - Estimar el efecto del tratamiento en la SLP y evaluar la probabilidad predictiva de éxito en un posible estudio de fase III posterior cuando se hayan observado 105 sucesos de SLP.
    - Evaluar las exposiciones farmacocinéticas (PK) de everolimus y pasireotida LAR.
    - Evaluar las posibles interacciones fármaco-fármaco PK entre everolimus y pasireotida LAR.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Tumor neuroendocrino pancreático (TNEP) en estadio avanzado (no resecable o metastásico), confirmado histológicamente, bien diferenciado (de grado bajo a intermedio).
    2. Documentación radiológica de enfermedad progresiva durante los últimos 12 meses antes de la aleatorización.
    3. Enfermedad medible según los criterios RECIST Versión 1.0 determinada mediante IRM multifase o TC trifásica.
    4. Pacientes adultos (hombres o mujeres) 18 años de edad.
    5. Estado funcional de la OMS 2
    6. Función adecuada de la médula ósea:
    WBC 2,5 x 109/l,
    RAN 1,5 x 109/l,
    Plaquetas 100 x 109/l,
    Hb 9 g/dl
    7. Ausencia de signos de enfermedad hepática/de páncreas significativos:
    Bilirrubina sérica 2,5 x LSN,
    INR < 1,3,
    ALT y AST 2,5 x LSN en pacientes sin metástasis hepáticas y 5 x LSN con metástasis hepáticas
    Lipasa y amilasa séricas 2 x LSN
    8. Creatinina sérica 2,0 mg/dl y tasa de filtración glomerular estimada (TFGe) > 30 ml/min/m2 (calculada con la fórmula MDRD).
    9. El consentimiento informado escrito se debe obtener antes de realizar cualquier procedimiento de selección.
    E.4Principal exclusion criteria
    1. que actualmente requieran tratamiento con SSA.
    2. que hayan recibido tratamiento previo con inhibidores mTOR (p. ej., sirolimus, temsirolimus, everolimus), o pasireotida.
    3. que hayan recibido cualquier quimioterapia citotóxica, terapia dirigida, SSA, o bioterapia durante las últimas 4 semanas.
    4. con más de 2 pautas de tratamiento sistémico previas.
    5. con hipersensibilidad conocida a SSA.
    6. con hipersensibilidad conocida a alguno de los componentes de pasireotida LAR o formulaciones s.c., everolimus u otros análogos de la rapamicina (sirolimus, temsirolimus) o a sus excipientes.
    7. Tratamiento previo con SSA radiomarcados durante los últimos 12 meses.
    8. con embolización arterial hepática, crioablación o ablación por radiofrecuencia de metástasis hepática durante últimos 3 meses antes aleatorización.
    9. que hayan recibido radioterapia en lesiones diana. Los que hayan recibido radioterapia local en lesiones no diana para un control local de los síntomas durante últimas 4 semanas deberán haberse recuperado de los efectos adversos de la radioterapia antes de la aleatorización.
    10. pacientes a los que se les haya realizado una intervención quirúrgica mayor/tratamiento quirúrgico por cualquier causa durante el último mes o tratamiento quirúrgico de las metástasis locorregionales durante últimos 3 meses antes de aleatorización. Los pacientes deberán haberse recuperado del tratamiento y tener buena condición clínica antes de entrar en este estudio.
    11. que estén recibiendo tratamiento crónico con corticoides u otro agente inmunosupresor.
    12. con colelitiasis sintomática.
    13. que no sean bioquímicamente eutiroideos. Pacientes con antecedentes de hipotiroidismo son elegibles si están con terapia sustitutiva con hormona tiroidea adecuada y estable durante al menos 3 meses.
    14. con coagulación anómala (TP [INR] o TTPA elevado un 30% por encima límites normales).
    15. Criterios de exclusión relacionados con el QT:
    con un QTcF basal > 450 ms,
    Antecedentes de síncope o antecedentes familiares de muerte súbita idiopática, síndrome de QT largo,
    Arritmias cardiacas sostenidas o clínicamente significativas,
    con factores de riesgo de torsades de pointes: potasio < 3,0 mmol/l, magnesio < 0,4 mmol/l o calcio < 1,75 mmol/l en la visita basal. Si las anormalidades relacionadas con electrolitos se corrigen antes de empezar con el fármaco del estudio, el paciente puede ser elegible para el ensayo. Insuficiencia cardiaca, bradicardia clínicamente significativa/sintomática o bloqueo AV de grado alto,
    Medicación concomitante que se sabe que prolonga el intervalo QT
    Enfermedad(es) concomitante(s) que puedan prolongar el QT como la neuropatía autonómica (causada por diabetes mellitus o enfermedad de Parkinson), VIH, cirrosis hepática, hipotiroidismo no controlado o insuficiencia cardiaca.
    16. Pacientes que tengan alguna enfermedad grave o no controlada u otras enfermedades que puedan afectar a su participación en el estudio tales como:
    Diabetes no controlada definida por HbA1c 8% a pesar de un tratamiento adecuado,
    Colesterol sérico en ayunas > 300 mg/dl (7,75 mmol/l) O triglicéridos en ayunas > 2,5 x LSN a pesar de los hipolipemiantes adecuados.
    Función pulmonar gravemente afectada definida según una espirometría y DLCO que sea un 50% del valor teórico normal o saturación de O2 que sea un 88% o un valor inferior en descanso a temperatura ambiente. La DLCO se debe ajustar al valor de hemoglobina y a los volúmenes pulmonares de los pacientes.
    Pacientes con presencia de infección no controlada aguda o crónica activa o sospecha de infección o con antecedentes de inmunodeficiencia, incluido un resultado positivo en la prueba de VIH (ELISA y Western blot). No será necesario realizar una prueba de VIH; no obstante, se revisarán los antecedentes patológicos.
    Enfermedades médicas no malignas que no estén controladas o cuyo control pueda verse afectado por el tratamiento de este estudio.
    Enfermedad hepática como cirrosis, enfermedad hepática descompensada, hepatitis crónica activa o hepatitis crónica persistente.
    Trastornos autoinmunes o isquémicos que pongan en peligro la vida.
    Pacientes con antecedentes de otro cáncer principal durante los 3 últimos años, con la excepción de cáncer cutáneo no melanoma localmente extirpado y carcinoma in situ de cuello uterino.
    Metástasis sintomáticas en el SNC que requieran tratamiento con corticoides.
    Pacientes que tengan alguna enfermedad actual o previa que pueda interferir en la realización del estudio o en la evaluación de sus resultados según la opinión del investigador o del monitor médico del promotor.
    17. con antecedentes de incumplimiento o considerados posiblemente no fiables o que no sean capaces de finalizar el estudio.
    18. que estén participando actualmente o hayan participado en alguna investigación clínica con un fármaco en investigación durante el mes anterior a la administración d la dosis.
    19. embarazadas o en periodo de lactancia
    E.5 End points
    E.5.1Primary end point(s)
    SLP según criterios RECIST 1.0. La SLP se define como el tiempo transcurrido desde la aleatorización hasta la fecha de la primera progresión de tumor documentada o muerte por cualquier causa, aquella que ocurra primero
    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 No
    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 Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    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 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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 150
    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 Decision2011-06-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-02-19
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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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