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    Summary
    EudraCT Number:2009-011128-70
    Sponsor's Protocol Code Number:CSOM230G2304
    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:2011-07-18
    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 number2009-011128-70
    A.3Full title of the trial
    Estudio de fase III, multicéntrico, aleatorizado y doble ciego, para evaluar la eficacia y seguridad de pasireotida LAR en pacientes con enfermedad de Cushing
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Estudio de fase III, de muchos centros, aleatorizado a dos dosis distintas de medicación sin que el médico ni el paciente sepa en cual está, para evaluar la eficacia y seguridad de pasireotida LAR (de larga duración) en pacientes con enfermedad de Cushing.
    A.4.1Sponsor's protocol code numberCSOM230G2304
    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 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 supportNovartis Farmacéutica, S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmacéutica, S.A.
    B.5.2Functional name of contact pointJavier Malpesa
    B.5.3 Address:
    B.5.3.1Street AddressGran via de les Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number933069464
    B.5.5Fax number933064615
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/09/671
    D.3 Description of the IMP
    D.3.1Product namepasireotide
    D.3.2Product code SOM230
    D.3.4Pharmaceutical form Powder for suspension for injection
    D.3.4.1Specific paediatric formulation No
    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/l milligram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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/3/09/671
    D.3 Description of the IMP
    D.3.1Product namepasireotide
    D.3.2Product code SOM230
    D.3.4Pharmaceutical form Powder for suspension for injection
    D.3.4.1Specific paediatric formulation No
    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/l milligram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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.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
    Enfermedad de Cushing
    E.1.1.1Medical condition in easily understood language
    Enfermedad de Cushing
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10011651
    E.1.2Term Cushing's disease
    E.1.2System Organ Class 10014698 - Endocrine disorders
    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 dos pautas posológicas de pasireotida LAR independientemente (dosis de inicio de 10 mg y 30 mg seguidas de un ajuste ascendente de la dosis si procede o de la continuación con la misma dosis) en pacientes con enfermedad de Cushing después de 7 meses de tratamiento, se haya realizado o no un ajuste ascendente de la dosis en el mes 4
    E.2.2Secondary objectives of the trial
    evaluar la eficacia de las dosis de pasireotida LAR 10 mg y 30 mg independientemente en pacientes con enfermedad de Cushing después de 7 meses de tratamiento a los que no se les realizó un ajuste ascendente de la dosis de pasireotida en el mes 4.
    Evaluar el cambio en CLUm respecto a la basal todos los meses en el estudio principal y cada tres meses en la fase de extensión en las dos pautas posológicas de pasireotida LAR.
    Evaluar la eficacia de las dos pautas posológicas de pasireotida LAR todos los meses en el estudio principal y cada tres meses en la fase de extensión.
    Evaluar la eficacia de las dos pautas posológicas de pasireotida LAR medida mediante los pacientes respondedores con CLUm controlado y parcialmente controlado combinados, todos los meses en el estudio principal y cada tres meses en la fase de extensión.
    Evaluar la frecuencia de la respuesta con CLUm controlado de las dos pautas posológicas de pasireotida LAR en los meses 7 y 12.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.El consentimiento informado escrito se debe obtener antes de realizar cualquier procedimiento de selección.
    2.Pacientes adultos con diagnóstico confirmado de enfermedad de Cushing dependiente de ACTH demostrado según lo siguiente:
    a.La media de las tres muestras de orina de 24 horas recogidas durante 2 semanas debe ser 1,5 x LSN y 5x LSN (según lo determinado por el laboratorio central de este estudio).
    b.ACTH plasmática matutina dentro del rango normal o por encima del rango normal.
    c.Confirmación por IRM de adenoma hipofisario > 6 mm, o gradiente del seno petroso inferior >3 después de estimulación con CRH en aquellos pacientes con un tumor menor o igual a 6 mm. En aquellos pacientes a los que se les haya realizado una cirugía hipofisaria previa, será necesaria una histopatología que confirme un adenoma con tinción para ACTH.
    3.Los pacientes con enfermedad de Cushing de novo se pueden incluir solo si no se consideran candidatos para cirugía hipofisaria
    4.Confirmación de que se excluye el pseudo-Cushing en los pacientes con CLUm menor de 3 x LSN
    E.4Principal exclusion criteria
    1.Pacientes que se consideren candidatos para tratamiento quirúrgico en el momento en el que entren en el estudio.
    2.Pacientes que hayan recibido irradiación hipofisaria durante los 10 años anteriores a la visita 1.
    3.Pacientes que hayan recibido previamente tratamiento con pasireotida.
    4.Pacientes que hayan sido tratados con mitotano durante los 6 meses anteriores a la visita 1.
    5.Pacientes con compresión de quiasma óptico que cause algún defecto en el campo visual que precise intervención quirúrgica.
    6.Pacientes diabéticos con medicación antihiperglucémica y un mal control glucémico demostrado según HbA1c >8%.
    7.Pacientes con factores de riesgo de torsada de pointes, es decir pacientes con un QTcF basal >470 ms, hipopotasemia, hipotiroidismo no controlado, antecedentes familiares de síndrome de QT largo o medicación concomitante conocida por prolongar el intervalo QT.
    8.Antecedentes de infección por VIH, incluido un resultado positivo en la prueba de VIH (Elisa y Western blot). No será necesario realizar una prueba de VIH; sin embargo se revisarán los antecedentes médicos.
    9.Pacientes con síndrome de Cushing debido a secreción ectópica de ACTH.
    10.Pacientes con hipercortisolismo secundario a tumores adrenales o hiperplasia adrenal bilateral nodular (primaria).
    11.Pacientes que tengan un síndrome heredado conocido como la causa del exceso de secreción de hormonal (es decir, complejo de Carney, síndrome McCune-Albright, MEN-1).
    E.5 End points
    E.5.1Primary end point(s)
    La variable de eficacia principal se define como la proporción de pacientes respondedores en cada una de las dos pautas posológicas de pasireotida LAR. Un respondedor se define como un paciente que alcanza un valor de CLUm 1,0 X LSN en el mes 7, independientemente del ajuste de la dosis.
    El CLUm en el mes 7 se determinará en el laboratorio central a partir de tres muestras de orina de 24 horas. Se hará una media de los resultados de las 3 muestras para obtener el nivel de CLUm correspondiente a la evaluación del mes 7.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Month 7
    E.5.2Secondary end point(s)
    Key secondary endpoint: Proportion of patients that attain a mUFC ? 1.0
    x ULN at Month 7 and had not had a dose increase at Month 4.
    For Other endpoint: refer to study protocol
    E.5.2.1Timepoint(s) of evaluation of this end point
    Month 7
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Argentina
    Brazil
    Canada
    China
    Japan
    Peru
    Russian Federation
    Singapore
    Thailand
    Turkey
    United States
    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
    Completion of the study as a whole (last patient last visit) will occur after all patients have completed all assessments as per protocol (core and extension phase) or have discontinued early.
    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 months4
    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 months4
    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.1.2.1Number of subjects for this age range: 8
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 64
    F.4.2.2In the whole clinical trial 162
    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)
    After the end of study visit, patients can be enrolled in an extension study during 12 months. Patients can continue in this extension study as long as they do not fulfill any of the study discontinuation criteria until the reach the month 24 visit.
    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 Decision2011-09-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-08-01
    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
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