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    Summary
    EudraCT Number:2015-004860-12
    Sponsor's Protocol Code Number:ERCAVATAR2015
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-02-17
    Trial 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 number2015-004860-12
    A.3Full title of the trial
    Integrated Genomics and Avatar Mouse Models for Personalized Treatment of Pancreatic Cancer
    Elección de terapias personalizadas en pacientes con carcinoma de páncreas metastásico de acuerdo al análisis genético del tumor y al modelo Avatar
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Integrated Genomics and Avatar Mouse Models for Personalized Treatment of Pancreatic Cancer
    Elección de terapias personalizadas en pacientes con carcinoma de páncreas metastásico de acuerdo al análisis genético del tumor y al modelo Avatar
    A.4.1Sponsor's protocol code numberERCAVATAR2015
    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 SponsorCentro Nacional Investigaciones Oncológicas (CNIO)
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCentro Nacional Investigaciones Oncológicas
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentro Nacional Investigaciones Oncológicas
    B.5.2Functional name of contact pointUnidad de Investigación
    B.5.3 Address:
    B.5.3.1Street AddressMelchor Fernández Almagro, 3
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28029
    B.5.3.4CountrySpain
    B.5.4Telephone number+349173280002922
    B.5.5Fax number+34912246931
    B.5.6E-mailsperea@cnio.es
    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.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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
    Metastatic pancreatic cancer
    Cáncer de páncreas metastásico
    E.1.1.1Medical condition in easily understood language
    Metastatic pancreatic cancer
    Cáncer de páncreas metastásico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10033610
    E.1.2Term Pancreatic carcinoma metastatic
    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 compare the efficacy of implementing an integrated genetics and avatar mouse model personalized treatment strategy to the conventional treatment strategy in patients with metastatic PDAC
    Comparar la eficacia de la implementación de una estrategia con tratamiento convencional personalizado basada en el análisis genético del tumor y el modelo avatar en ratón en pacientes con cáncer de páncreas metastásico
    E.2.2Secondary objectives of the trial
    - To compare the response rates, progression-free survival and CA 19.9 tumor marker modulation effects of patients with metastatic pancreatic cancer treated with a personalized approach to the conventional treatment strategy.
    - To determine the genomic landscape of metastatic PDAC.
    - To generate Avatar mouse models from metastatic PDAC.
    - To develop customized disease monitoring based on mutation analysis in extracellular circulating DNA and circulating exosomes.
    - To attempt generating Avatar models from circulating tumor cells.
    - Comparar las tasas de respuesta, la supervivencia libre de progresión y los efectos de modulación sobre el marcador tumoral CA 19.9 en pacientes con cáncer de páncreas metastásico tratados con un tratamiento personalizado basado en tratamientos convencionales.
    - Determinar el mapa genético del cáncer de páncreas metastásico.
    - Generar modelos de ratón Avatar de cáncer de páncreas metastásico.
    - Desarrollar una monitorización personalizada de la enfermedad basada en el análisis de mutaciones en el ADN extracelular circulante y exosomas circulantes.
    - Generar modelos Avatar a partir de células tumorales circulantes
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients who are 18 years or older;
    2. Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas.
    3. One or more metastatic tumor sites that are amenable for biopsy.
    4. Measurable or evaluable disease.
    5. Patients must have received either no previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease or be within the first 3 cycles of first line chemotherapy. Palliative radiotherapy for bone metastasis is allowed.
    6. Adequate blood counts at baseline (obtained <=14 days prior to randomization):
    - Absolute neutrophil count (ANC) >= 1.5 × 109/L;
    - Platelet count >= 100,000/mm3 (100 × 109/L);
    - Hemoglobin (Hgb) >= 9 g/dL.
    7. Patient has the following blood chemistry levels at baseline:
    - AST (SGOT), ALT (SGPT) <= 2.5 × upper limit of normal range (ULN), unless liver metastases are clearly present, then <= 5 × ULN is allowed
    - Total bilirubin <= 1.5 x ULN
    - Total albumin >= 0.75 ULN
    - Serum creatinine <= 1.5 x ULN
    8. Eastern Cooperative Oncology Group (ECOG) performance score of 1 or lower.
    9. Written informed consent.
    10. Patient of child-bearing potential (for female patient: study entry after a menstrual period and a negative pregnancy test) must agree to use two medically acceptable methods of contraception during the study and for 4 months after the last study treatment intake for women and 6 months for men.
    1. Edad mayor de 18 años
    2. Confirmación histológica o citológica de adenocarcinoma metastásico de páncreas.
    3. Uno o más sitios tumorales metastásicos susceptibles de biopsiar.
    4. Enfermedad medible o evaluable.
    5. Los pacientes no deben haber recibido radioterapia, cirugía, quimioterapia o cualquier tratamiento en investigación para el tratamiento de la enfermedad metastásica o estará dentro de los 3 primeros ciclos de quimioterapia de primera línea. Se permite la radioterapia paliativa para las metástasis óseas.
    6. Hemograma adecuado al inicio del estudio, obtenidos <= 14 días antes de la aleatorización:
    - Recuento absoluto de neutrófilos (RAN) >= 1,5 x 109 / l;
    - Plaquetas >= 100.000 / mm3 (100 × 109 / L);
    - Hemoglobina (Hb) >= 9 g / dl.
    7. Bioquímica sanguínea adecuada al inicio del estudio:
    - AST (SGOT), ALT (SGPT) <= 2.5 × límite superior de normalidad (LSN), a menos que haya presencia de metástasis hepáticas, entonces se permite <= 5 × LSN
    - Bilirrubina total <= 1,5 x LSN
    - Albúmina total >= 0,75 LSN
    - Creatinina sérica <= 1,5 x LSN
    8. ECOG PS 0 - 1.
    9. Consentimiento informado por escrito.
    10. Los pacientes en edad fértil deben estar de acuerdo en utilizar métodos anticonceptivos adecuados durante el estudio.
    E.4Principal exclusion criteria
    1. Known brain metastases, unless previously treated and well-controlled for at least 3 months.
    2. Only locally advanced disease.
    3. History of malignancy in the last 5 years.
    4. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
    5. Contraindication for performing a tumor biopsy.
    6. Known historical or active infection with HIV, hepatitis B, or hepatitis C.
    7. High cardiovascular risk, including, but not limited to, recent coronary stenting or myocardial infarction in the past year.
    8. Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the patient's safety or the study data integrity.
    9. Female patient is pregnant or breast-feeding.
    10. Unwilling or unable to comply with study procedures. The patients must be agreeable to performing a tumor biopsy if allocated to the interventional arm.
    1. Metástasis cerebrales conocidas, a menos que hayan sido tratadas previamente y estén controladas durante al menos 3 meses.
    2. Únicamente enfermedad localmente avanzada.
    3. Historia de cáncer en los últimos 5 años.
    4. Infección activa, no controlada, bacteriana, viral o fúngica que requieran tratamiento sistémico.
    5. Contraindicaciones para la realización de la biopsia del tumor.
    6. Infección previa o activa por VIH, hepatitis B, o hepatitis C.
    7. Alto riesgo cardiovascular, incluyendo, pero no limitado a, la implantación reciente de un stent coronario o infarto de miocardio en el pasado año.
    8. Factores de riesgo graves que implican cualquiera de los principales órganos, o trastornos psiquiátricos graves, que podrían comprometer la seguridad o la integridad de los datos del estudio.
    9. Paciente embarazada o en periodo de lactancia.
    10. Pacientes incapaces de cumplir con los procedimientos del estudio. Los pacientes deben estar de acuerdo en la realización de una biopsia del tumor si son asignados al brazo de intervención.
    E.5 End points
    E.5.1Primary end point(s)
    One year survival rate.
    Supervivencia a un año
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 year
    1 año
    E.5.2Secondary end point(s)
    - Objective tumor response
    - Progression-free survival
    - CA 19.9 tumor measurements
    - Determine whether a correlation exists between mutation analysis in extracellular circulating DNA and efficacy outcomes
    - Tasa de respuesta objetiva
    - Spervivencia libre de progresión
    - Variaciones del marcador CA 19.9
    - Determinar si existe correlación entre las mutaciones encontradas en el ADN extracelular circulante y las variables de eficacia
    E.5.2.1Timepoint(s) of evaluation of this end point
    Every 8-12 weeks
    Cada 8-12 semanas
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    Last visit of the last subject
    Última 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 months
    E.8.9.1In the Member State concerned days
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 46
    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 state146
    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)
    The expected normal treatment of that condition
    El tratamiento habitual para esta anfermedad
    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 Decision2016-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-09
    P. End of Trial
    P.End of Trial StatusOngoing
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