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    Summary
    EudraCT Number:2014-005607-24
    Sponsor's Protocol Code Number:8-79-52030-326
    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:2015-10-05
    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 number2014-005607-24
    A.3Full title of the trial
    Efficacy and safety of lanreotide Autogel® 120 mg administered every 14 days in well differentiated, metastatic or locally advanced, unresectable pancreatic or midgut neuroendocrine tumours having progressed radiologically while previously treated with lanreotide Autogel® 120 mg administered every 28 days
    Eficacia y seguridad de lanreotide Autogel® 120 mg administrado cada 14 días en tumores neuroendocrinos de intestino medio o pancreáticos irresecables localmente avanzados o metastásicos bien diferenciados que han progresado radiológicamente durante el tratamiento anterior con lanreotide Autogel® 120 mg administrado cada 28 días.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of lanreotide Autogel® 120 mg administered every 14 days in pancreatic or midgut neuroendocrine tumours having progressed radiologically while previously treated with lanreotide Autogel® 120 mg administered every 28 days
    Eficacia y seguridad de lanreotide Autogel® 120 mg administrado cada 14 días en tumores neuroendocrinos de intestino medio o pancreáticos que han progresado radiológicamente durante el tratamiento anterior con lanreotide Autogel® 120 mg administrado cada 28 días.
    A.4.1Sponsor's protocol code number8-79-52030-326
    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 SponsorIpsen Innovation
    B.1.3.4CountryFrance
    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 supportIpsen Innovation
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIpsen Innovation
    B.5.2Functional name of contact pointMedical Affairs, Endocrinology
    B.5.3 Address:
    B.5.3.1Street Address65 Quai George Gorse
    B.5.3.2Town/ cityBoulogne Billancourt
    B.5.3.3Post code92100
    B.5.3.4CountryFrance
    B.5.4Telephone number+3358 33 50 00
    B.5.5Fax number+3358 33 50 01
    B.5.6E-mailct-application@ipsen.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 Yes
    D.2.1.1.1Trade name Somatuline Autogel 120 mg
    D.2.1.1.2Name of the Marketing Authorisation holderIpsen Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameSomatuline Autogel
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    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 INNLanreotide (INN) acetate
    D.3.9.1CAS number 127984-74-1
    D.3.9.2Current sponsor codeBN52030, BIM-23014C
    D.3.9.3Other descriptive nameLANREOTIDE ACETATE
    D.3.9.4EV Substance CodeSUB14326MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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
    Well differentiated, metastatic or locally advanced, unresectable pancreatic or midgut neuroendocrine tumours
    Tumores neuroendocrinos de intestino medio o pancreáticos irresecables localmente avanzados o metastásicos bien diferenciados
    E.1.1.1Medical condition in easily understood language
    Pancreatic or midgut neuroendocrine tumours
    Tumores neuroendocrinos de intestino medio o pancreáticos
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10052399
    E.1.2Term 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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess progression free survival (PFS) when treated with lanreotide Autogel® 120 mg administered every 14 days based on Response Evaluation Criteria in Solid Tumours (RECIST) v1.0, and according to central review
    Evaluar la supervivencia libre de progresión (SLP) cuando se trata con lanreotide Autogel® 120 mg administrado cada 14 días, basándose en los Criterios de evaluación de respuesta en tumores sólidos (RECIST) v1.0 y de acuerdo con la revisión central.
    E.2.2Secondary objectives of the trial
    To evaluate the clinical and biological safety profile.
    To evaluate time to progression.
    To evaluate PFS rate every 12 weeks.
    To evaluate overall survival at Week 48 and at the end of the study period in each cohort.
    To evaluate the objective response rate (ORR) as per RECIST v1.0 every 12 weeks.
    To evaluate the disease control rate (DCR) as per RECIST v1.0 at Weeks 24 and 48 and at the end of study period in each cohort.
    To evaluate the best overall response as per RECIST v1.0.
    To evaluate the duration of stable disease (SD) as per RECIST v1.0.
    To detect predictive factors of PFS.
    To evaluate the effect on symptoms (diarrhoea, flushing).
    To evaluate quality of life.
    To evaluate the changes in nonspecific (Chromogranin A (CgA), neuron specific enolase (NSE) and 5 hydroxyindoleacetic acid (5 HIAA) and specific peptide tumour biomarkers.
    To evaluate the appearance of antilanreotide antibodies.
    To evaluate the pharmacokinetic (PK) profile of lanreotide
    Evaluar el perfil de seguridad clínico y biológico.
    Evaluar el tiempo hasta la progresión.
    Evaluar la tasa de SLP cada 12 semanas.
    Evaluar la supervivencia global en la semana 48 y al final del período de estudio en cada cohorte.
    Evaluar la tasa de respuesta objetiva(TRO)según RECIST v1.0 cada 12 semanas.
    Evaluar la tasa de control de la enfermedad(TCE) según RECIST v1.0 en las semanas 24 y 48 y al final del período de estudio en cada cohorte.
    Evaluar la mejor respuesta general según RECISTv1.0.
    Evaluar la duración de la enfermedad estable(EE) según RECISTv1.0.
    Detectar los factores predictivos de laSLP.
    Evaluar el efecto sobre los síntomas (diarrea, rubefacción).
    Evaluar la calidad de vida.
    Evaluar los cambios en los biomarcadores tumorales de los péptidos específicos y no específicos (cromogranina A[CgA], enolasa neuronal específica [ENE) y ácido 5-hidroxiindolacético [5-HIAA]).
    (..)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Male or female subjects aged 18 years old or older.
    2) Histopathologically confirmed well differentiated (grade 1 or grade 2 according to the WHO 2010 classification), metastatic or locally advanced, unresectable pNET (pNET cohort) or midgut NET (midgut cohort) with or without hormone related syndromes, with a proliferation index (Ki67) ?20%.
    3) Positive somatostatin receptors type 2 (SSTR2) as assessed by imaging (scintigraphy or positron emission tomography (PET) scan) in the organs of target lesions.
    4) Progression as assessed by an independent central reviewer according to RECIST v1.0 from radiological imaging (CT scan or MRI) while receiving first line treatment with lanreotide Autogel® at a standard dose of 120 mg every 28 days for at least 24 weeks (6 injections). Progression must be radiologically documented using the same technique of images (CT scan or MRI) within 24 months prior to enrolment. Inclusion into the study must be within 28 days of the radiological imaging that is performed to document progression.
    5) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2.
    6) Provision of written informed consent prior to any study related procedures.
    7) Female subjects of childbearing potential (not surgically sterile or 2 years postmenopausal) must provide a negative urine pregnancy test at Screening, and use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 2 months after participation in the study. Acceptable methods of contraception include double barrier method, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted and injected).
    8) Subjects must be willing and able to comply with study restrictions and willing to return to the clinic for the follow up evaluation as specified in the protocol.
    1) Sujetos del sexo masculino o femenino, de 18 años de edad o más.
    2) TNE de intestino medio (cohorte de intestino medio) o TNEp (cohorte de TNEp) irresecables localmente avanzados o metastásicos bien diferenciados (grado 1 o 2 según la clasificación de la OMS de 2010) confirmados histopatológicamente con o sin síndromes relacionados con las hormonas, con un índice de proliferación (Ki67) ? 20 %.
    3) Receptores de somatostatina positivos de tipo 2 (SSTR2) evaluados mediante imágenes (tomografía de emisión de positrones (TEP) o gammagrafía) en los órganos de las lesiones diana.
    4) Progresión evaluada por un revisor central independiente según RECIST v1.0 a partir de imágenes radiológicas (TC o RM) mientras recibe tratamiento de primera línea con lanreotide Autogel® en una dosis estándar de 120 mg cada 28 días durante al menos 24 semanas (6 inyecciones). La progresión debe documentarse radiológicamente con la misma técnica de imágenes (exploración por TC o RM) en un plazo de 24 meses antes de la inscripción. La inclusión en el estudio debe realizarse en un plazo de 28 días desde las imágenes radiológicas que se realicen para documentar la progresión.
    5) Estado funcional (PS) del Grupo Oncológico Cooperativo del Este (Eastern Cooperative Oncology Group, ECOG) de 0 a 2.
    6) Entrega del consentimiento informado por escrito antes de cualquier procedimiento relacionado con el estudio.
    7) Las participantes del sexo femenino en edad fértil (no esterilizadas quirúrgicamente o que lleven 2 años de posmenopausia) deben proporcionar una prueba de embarazo en orina negativa en la selección, usar un método anticonceptivo médicamente aceptado y estar de acuerdo en continuar con el uso de este método durante el estudio y durante 2 meses después de la participación en el estudio. Los métodos anticonceptivos aceptables incluyen métodos de doble barrera, dispositivo intrauterino (DIU) o anticonceptivos esteroideos (orales, transdérmicos, implantados e inyectados).
    8) Los sujetos deben ser capaces y estar dispuestos a cumplir con las restricciones del estudio y estar dispuestos a acudir a la clínica para la evaluación de seguimiento especificada en el protocolo.
    E.4Principal exclusion criteria
    1) Has poorly differentiated grade 3 NET or rapidly progressive NET (within 12 weeks of initiation of lanreotide Autogel® 120 mg every 28 days) as per RECIST v1.0.
    2) Has been diagnosed with VIPoma (i.e. Verner Morrison syndrome), insulinoma, foregut (except for pNET), hindgut NET, unknown primary NET or multiple endocrine neoplasms (MEN).
    3) Has progressed during treatment with somatostatin analogues (SSAs) other than lanreotide Autogel® 120 mg.
    4) Has been previously treated with any antitumour agent for NET other than lanreotide Autogel® 120 mg every 28 days: chemotherapy, molecular targeted therapy, peptide receptor radionuclide therapy (PRRT) or interferon.
    5) Has had major surgery related to the studied disease within 3 months prior to entering the study. Previous debulking surgery and chemoembolisation are acceptable as long as tumour burden is measurable (other target lesions).
    6) Has gallbladder lithiasis at Screening echography or a history of cholelithiasis with no cholecystectomy since then.
    7) Has had previous cancer, except basocellular carcinoma of the skin and/or in situ carcinoma of the cervix/uterus and/or subjects treated with curative intent and free from disease for more than 5 years.
    8) Was treated with any other investigational medicinal product (IMP) within the last 30 days before study entry.
    9) Is pregnant or lactating.
    10) Has abnormal findings at Screening, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardise the subject's safety.
    11) Has any mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
    12) Has been previously screened in this study.
    13) Has a history of hypersensitivity to lanreotide Autogel® or drugs with a similar chemical structure, or any excipient used in the formulation.
    14) Is likely to require treatment during the study with drugs that are not permitted by the study protocol.
    15) Has a history of, or known current, problems with substance or alcohol abuse.
    1) TNE de grado 3 mal diferenciado o TNE de progresión rápida (en un plazo de 12 semanas desde el inicio del lanreotide Autogel® 120 mg cada 28 días) según RECIST v1.0.
    2) Se le ha diagnosticado VIPoma (es decir, síndrome de Verner Morrison), insulinoma, intestino anterior (excepto para TNEp), TNE de intestino posterior, TNE primario desconocido o varias neoplasias endocrinas (VNE).
    3) Ha tenido progresión durante el tratamiento con análogos de la somatostatina (SS) que no sean lanreotide Autogel® 120 mg.
    4) Ha sido tratado previamente con cualquier agente antitumoral para TNE distinto a lanreotide Autogel® 120 mg cada 28 días: quimioterapia, terapia dirigida molecular, terapia de radionucleidos de receptores de péptidos (TRRP) o interferón.
    5) Se ha sometido a cirugía mayor en relación con la enfermedad estudiada en los 3 meses anteriores a la entrada en el estudio. La cirugía de reducción de volumen anterior y la quimioembolización son aceptables siempre y cuando la carga tumoral
    sea medible (otras lesiones diana).
    6) Tiene litiasis de la vesícula biliar en la ecografía de selección o antecedentes de colelitiasis sin colecistectomía desde entonces.
    7) Ha tenido un cáncer anterior, excepto el carcinoma basocelular de la piel y/o el carcinoma in situ del cuello uterino/útero y/o el sujeto ha sido tratado con intención curativa y lleva sin enfermedad más de 5 años.
    8) Se le ha tratado algún otro medicamento en investigación (PEI) en los últimos 30 días antes de entrar en el estudio.
    9) Está embarazada o en periodo de lactancia.
    10) Tiene hallazgos anómalos en la selección, cualquier otra afección médica o hallazgos de laboratorio que, en opinión del investigador, podrían poner en peligro la seguridad del sujeto.
    11) Tiene alguna enfermedad mental que incapacite al sujeto para entender la naturaleza, el alcance y las posibles consecuencias del estudio, y/o indicios de actitud poco cooperativa.
    12) Ya se le ha seleccionado previamente para este estudio.
    13) Tiene antecedentes de hipersensibilidad a lanreotide Autogel® o a fármacos con una estructura química parecida, o a cualquier excipiente utilizado en la formulación.
    14) Es probable que requiera tratamiento durante el estudio con fármacos que no estén permitidos conforme al protocolo de estudio.
    15) Tiene antecedentes de o problemas actuales conocidos de abuso de estupefacientes o de alcohol.
    E.5 End points
    E.5.1Primary end point(s)
    Median PFS
    Mediana del tiempo hasta la progresión
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every 12 weeks or death date
    Cada 12 semanas o hasta la fecha de fallecimiento.
    E.5.2Secondary end point(s)
    Median time to progression
    Proportion of subjects alive and without progression
    Overall survival
    ORR
    DCR
    Best overall response
    Median duration of SD
    Factors associated with PFS
    Symptom control (diarrhoea and flushing)
    Quality of life
    Tumour biomarker concentrations
    Mediana del tiempo hasta la progresión
    Proporción de sujetos vivos y sin progresión
    Supervivencia global
    TRG
    TCE
    Mejor respuesta general
    La mediana de la duración de la EE
    Los factores asociados a la SLP
    Control de los síntomas (diarrea, rubefacción)
    La calidad de vida medida
    Las concentraciones de biomarcadores tumorales
    E.5.2.1Timepoint(s) of evaluation of this end point
    Defined time points of evaluation for each end point as per protocol
    Definidos los tiempos de evaluación de los criterios de valoración para cada criterio según el protocolo.
    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 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 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 Yes
    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.8.2.4Number of treatment arms in the trial1
    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 EEA27
    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
    Denmark
    France
    Germany
    Ireland
    Italy
    Netherlands
    Poland
    Spain
    United Kingdom
    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
    LPLV
    Ultima visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    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 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: 55
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 45
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 86
    F.4.2.2In the whole clinical trial 100
    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)
    None
    Ninguno
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Medical Research Network Limited
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-11-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-10-24
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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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