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    Summary
    EudraCT Number:2008-007348-32
    Sponsor's Protocol Code Number:SOM230D2203
    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:2010-02-23
    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 number2008-007348-32
    A.3Full title of the trial
    Estudio abierto multicéntrico, con un único brazo de tratamiento con Pasireotide LAR, en pacientes con tumores poco frecuentes de origen neuroendocrino
    A.4.1Sponsor's protocol code numberSOM230D2203
    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 Farmaceútica 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 numberEC/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.3.11 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 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 numberEC/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.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 numberEC/3/04/200
    D.3 Description of the IMP
    D.3.1Product namepasireotide
    D.3.2Product code SOM230
    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 IMPSubcutaneous 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 µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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
    Se incluirán los siguientes tumores:
    1. NETs del páncreas
    Insulinoma
    Gastrinoma
    VIPoma
    Glucagonoma
    2. NETs pituitarios
    Prolactinoma (PRL)
    Adenoma pituitario-tirotropo (TSH)
    Adenoma gonadotropo
    Adenoma pituitario no funcional (NFPA)
    3. Tumores ectópicos que secretan ACTH (EAS)
    4. Síndrome de Nelson
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10062476
    E.1.2Term Neuroendocrine tumor
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar la eficacia de pasireotide LAR en NETs pancreáticos (insulinoma, gastrinoma, VIPoma y glucagonoma) basado en marcadores tumorales bioquímicos primarios específicos de la enfermedad.
    E.2.2Secondary objectives of the trial
    •Evaluar la eficacia de pasireotide LAR en cada uno de los NETs pancreáticos (insulinoma, gastrinoma, VIPoma y glucagonoma) basado en marcadores tumorales bioquímicos primarios específicos de la enfermedad.
    •Evaluar la eficacia de pasireotide LAR en cada uno de los otros NETs poco frecuentes que incluyen prolactinoma, adenoma tirotropo, adenoma gonadotropo, adenoma pituitario no funcional, tumores ectópicos que secretan ACTH y síndrome de Nelson basado en marcadores tumorales bioquímicos primarios específicos de la enfermedad.
    •Evaluar la seguridad y la tolerabilidad global de pasireotide LAR
    •Evaluar el efecto de pasireotide LAR en los síntomas relacionados con la enfermedad
    •Evaluar las concentraciones plasmáticas valle farmacocinéticas (PK) de pasireotide LAR
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Dentro del protocolo original se incluye el subestudio farmacogenético.
    E.3Principal inclusion criteria
    1. Pacientes varones o mujeres &#8805;18 años
    2. Pacientes que no hayan respondido a la terapia estándar o para los que no exista tratamiento estándar
    3. Los pacientes con tumores neuroendocrinos pancreáticos poco frecuentes deberán cumplir todo lo siguiente:
    •Confirmación patológica: los pacientes deberán tener carcinoma neuroendocrino de grado bajo o intermedio histológica o citológicamente confirmado. Los pacientes con carcinoma neuroendocrino pobremente diferenciado, carcinoma neuroendocrino de alto grado, adenocarcinoide o carcinoide de células globet, no son elegibles. Si el informe patológico sólo indica carcinoma neuroendocrino, entonces el subtipo histológico deberá reconfirmarse.
    •Enfermedad no resecable o metastásica avanzada.
    •Los pacientes deberán presentar evidencia bioquímica de producción hormonal o síntomas clínicos que coincidan con diagnóstico de insulinoma, gastrinoma, VIPoma o glucagonoma, Suplemento 1. La evidencia bioquímica puede incluir valores de una naturaleza histórica: (1) valores utilizados para establecer el diagnóstico original y/o (2) el(los) último(s) valor(es) anormal(es) disponible(s) más recientes.
    4. Los pacientes con tumores neuroendocrinos pituitarios poco frecuentes deberán cumplir todo lo siguiente:
    •RM que documente la presencia de un tumor pituitario
    •Los pacientes deberán presentar evidencia bioquímica de secreción producción hormonal (y síntomas clínicos consistentes con diagnóstico de adenoma secretor de TSH, gonadotropo secretor, secretor de prolactina o pituitario no funcional, Suplemento 1. La evidencia bioquímica puede incluir valores de una naturaleza histórica: (1) valores utilizados para establecer el diagnóstico original y/o (2) el(los) último(s) valor(es) anormal(es) disponible(s) más recientes.
    5. Los pacientes con tumores EAS y síndrome de Nelson deberían tener diagnóstico confirmado por el investigador con criterios consistentes con el Suplemento 1. La evidencia bioquímica puede incluir valores de una naturaleza histórica: (1) valores utilizados para establecer el diagnóstico original y/o (2) el(los) último(s) valor(es) anormal(es) disponible(s) más recientes.
    6. Estado funcional del ECOG &#8804; 2.
    7. Deberán transcurrir los siguientes intervalos entre la última inyección del tratamiento previo de los pacientes y la primera inyección de la medicación del estudio:
    • Octreotida LAR = 28 días (4 semanas)
    • Octreotida s.c. = 8 horas
    • Lanreotida Autogel = 28 días (4 semanas)
    • Lanreotida SR = 14 días (2 semanas)
    8. Consentimiento informado por escrito antes de cualquier procedimiento de selección
    E.4Principal exclusion criteria
    1. Pacientes con enfermedad de la vesícula biliar activa
    2. Pacientes con alguna terapia antineoplásica prevista o en curso
    3. pacientes con alguna terapia prevista o en curso con interferón
    4. Pacientes con diabetes mellitus incontrolada indicado por la presencia de HbA1c > 8% (No aplicable para los pacientes con glucagonoma)
    5. Pacientes que hayan recibido terapia con análogo de la somatostatina radioetiquetado dentro de los 6 meses de la visita 1, terapia citotóxica o interferón dentro de los 2 meses de la visita 1 o radioterapia dentro del mes previo a la visita 1.
    6. Pacientes que presenten cualquier condición médica previa o actual que pueda interferir con la realización del estudio o en la evaluación de sus resultados, a criterio del investigador o del monitor clínico del promotor.
    7. Como fármaco de esta clase, por ejemplo, octreotida ha demostrado que causa prolongación del intervalo QT, los pacientes con historial clínico previo o actual de anomalías de ECG clínicamente significativas (véase, criterios a continuación), enfermedad cardíaca importante (por ejemplo, aterosclerosis, insuficiencia cardíaca) o factores de riesgo de torsades de pointes, es decir, antecedentes familiares/historial de síndrome de intervalo QT prolongado, serán excluidos.
    ECG anormal se define como:
    • PR> 220 mseg, complejo QRS > 110 mseg, QTcB > 450 mseg
    • Cualquier anomalía en la conducción cardíaca
    • Cualquier anomalía morfológica
    8. Pacientes con coagulación anormal (PT o APTT elevados un 30% por encima de los límites de normalidad)
    9. Pacientes embarazadas, en periodo de lactancia o físicamente fértiles y que no practiquen un método anticonceptivo clínicamente aceptable.
    • Las pacientes potencialmente fértiles deberán utilizar anticonceptivos de barrera con preservativo. El uso de dispositivo intrauterino y de anticonceptivos orales se permite a todas las mujeres, excepto a aquellas con diagnóstico de adenoma pituitario no funcional y adenoma gonadotropo.
    • Si se utilizan anticonceptivos orales además de preservativos, la paciente deberá haber practicado este método durante por lo menos dos meses antes de la inclusión y deberá acceder a continuar el método anticonceptivo oral durante todo el transcurso del estudio y durante tres meses después de que el estudio haya finalizado.
    • Los pacientes varones sexualmente activos es preciso que utilicen preservativos durante el estudio y durante tres meses después como medida de precaución (los datos disponibles no indican aumento del riesgo reproductivo y o teratogénico con las medicaciones del estudio). Las parejas femeninas de estos pacientes varones deberán utilizar un anticonceptivo de barrera secundario.
    10. Pacientes que hayan participado en alguna investigación clínica con un fármaco en investigación durante los 30 días previos a la dosis
    11. Pacientes con antecedentes de incumplimiento con regímenes médicos o que se consideren potencialmente no fiables o incapaces de completar todo el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    La variable de eficacia principal es el porcentaje de pacientes que presenten respuestas en el marcador tumoral bioquímico entre los pacientes con NETs pancreáticos (insulinoma, gastrinoma, VIPoma y glucagonoma)
    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 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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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 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
    After 6 months treatment, patients who don't demonstrate clinical benefit will be discontinued, those who don't meet prespecified criteria but benefit from treatment and those who demonstrate clinical benefit may continue in the extension study. Extension: Patients to be treated for up to 2 years or until pasireotide or other effective therapy is commercially available. If pasireotide isn't commercially available after 2years of treatment, extension of the trial will be considered.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years12
    E.8.9.1In the Member State concerned months7
    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 months0
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 41
    F.4.2.2In the whole clinical trial 100
    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 Decision2010-04-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-04-19
    P. End of Trial
    P.End of Trial StatusCompleted
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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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