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    Summary
    EudraCT Number:2010-024292-30
    Sponsor's Protocol Code Number:PM1183-B-001-10
    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:2011-11-23
    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 number2010-024292-30
    A.3Full title of the trial
    Estudio de fase II de PM01183 como tratamiento de segunda línea en pacientes con cáncer de páncreas metastásico.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of PM01183 in Patients with Metastatic Pancreatic Cancer
    Estudio de PM01183 en pacientes con cáncer de páncreas metastásico.
    A.4.1Sponsor's protocol code numberPM1183-B-001-10
    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 SponsorPharma Mar, S.A. Sociedad Unipersonal
    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 supportPharma Mar, S.A. Sociedad Unipersonal
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharma Mar, S.A. Sociedad Unipersonal
    B.5.2Functional name of contact pointAna Irigaray
    B.5.3 Address:
    B.5.3.1Street AddressAv. de los Reyes, 1- Pol. Ind. "La Mina"
    B.5.3.2Town/ cityColmenar Viejo/Madrid
    B.5.3.3Post code28770
    B.5.3.4CountrySpain
    B.5.4Telephone number+3491846 30 31
    B.5.5Fax number+3491823 45 03
    B.5.6E-mailabirigaray@pharmamar.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePM01183
    D.3.2Product code PM01183
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNo aplicable
    D.3.9.1CAS number 497871-47-3
    D.3.9.2Current sponsor codePM01183
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePM01183
    D.3.2Product code PM01183
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPM01183
    D.3.9.1CAS number 497871-47-3
    D.3.9.2Current sponsor codePM01183
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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
    Cáncer de páncreas metastásico.
    E.1.1.1Medical condition in easily understood language
    Pancreatic cancer that has spreaded to other organs
    Cáncer de páncreas con afectación de otros órganos
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10007109
    E.1.2Term Cancer of pancreas (excl head) 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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar la actividad antitumoral de PM01183 en términos de supervivencia global a los 6 meses (SG6) en pacientes con cáncer de páncreas metastásico.
    E.2.2Secondary objectives of the trial
    Supervivencia libre de progresión (SLP) y tasa de supervivencia libre de progresión a los tres (SLP3) y a los seis (SLP6) meses.
    Tasa de respuesta según la versión 1.1 de RECIST (Response Evaluation Criteria in Solid Tumors) y duración de la respuesta.
    Evolución de los marcadores tumorales (CA19-9) durante el tratamiento.
    Supervivencia global (SG) y tasa de supervivencia global a los 12 meses (SG12).
    Evaluación de seguridad en esta población de pacientes.
    Análisis farmacocinético (FC) en esta población de pacientes.
    Correlación farmacocinética/ farmacodinámica (FD/FD), si fuera pertinente.
    Evaluación de la farmacogenómica (FGx) en muestras tumorales previamente disponibles / muestras de sangre extraídas antes del inicio del tratamiento con PM01183, con el fin de identificar posibles marcadores de sensibilidad o resistencia al fármaco
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Elegibles todos los pacientes tratados en el estudio PM1183-B-001-10.Pacientes que hayan otorgado voluntariamente su consentimiento firmando el formulario.La negativa a participar en el estudio FGx no afectará la participación en el estudio clínico PM1183-B-001-10.objetivo del estudio FGx es identificar posibles biomarcadores de sensibilidad o resistencia a PM01183 y cuya expresión podría permitir predecir el resultado clínico del tratamiento con PM01183.
    E.3Principal inclusion criteria
    1. Obtención del formulario de consentimiento informado (FCI) por escrito, otorgado voluntariamente antes de cualquier procedimiento específico del ensayo.
    2. Pacientes con diagnóstico histológico/citológico de cáncer del páncreas exocrino.
    3. Enfermedad grado IV.
    4. La enfermedad debe haber progresado durante o después del tratamiento anterior con gemcitabina.
    5. Edad 18 años.
    6. Estado funcional (EF) en la escala del Eastern Cooperative Oncology Group (ECOG) 1.
    7. Funciones hematológica, renal, metabólica y hepática adecuadas.
    a. Hemoglobina 9 g/dl (los pacientes pueden haber recibido transfusión de eritrocitos previa, si estuviera clínicamente indicado); recuento absoluto de neutrófilos (RAN) 1,5 x 109/l, y recuento de plaquetas 80 x 109/l.
    b. Alanina aminotransferasa (ALT), y aspartato aminotransferasa (AST) 3,0 x límite superior normal (LSN) ( 5,0 LSN en caso de metástasis hepáticas).
    c. Bilirrubina total 1,5 x LSN o bilirrubina directa LSN.
    d. Cociente internacional normalizado (INR) < 1,5 (excepto si el paciente recibe tratamiento anticoagulante oral).
    e. Albúmina 2,5 g/dl.
    f. Aclaramiento de creatinina calculado (CrCl) 30 ml/min (mediante la fórmula de Cockcroft y Gault).
    g. Creatinina-fosfocinasa (CPK) 2,5 x LSN.
    8. Pacientes que no estén extremadamente enfermos y/o con riesgo vital inmediato.
    9. Pacientes sin enfermedad maligna anterior o concurrente, a menos que se haya observado remisión completa durante más de tres años, excepto carcinoma cervicouterino in situ adecuadamente tratado, carcinoma cutáneo de células basales o escamosas o carcinoma in situ de células transicionales de la vejiga.
    10. Por lo menos dos semanas de intervalo desde el último tratamiento previo (por lo menos cuatro semanas desde la finalización de la radioterapia si fuera aplicable) y recuperación hasta el grado 1 de cualquier acontecimiento adverso (AA) derivado de tratamientos anticancerosos previos (con exclusión de alopecia y/o toxicidad cutánea de cualquier grado y astenia y/o neuropatía periférica, ambas grado 2) con arreglo a los criterios NCI-CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Event) versión 4.
    11. Las mujeres en edad fértil deben tener un resultado negativo en la prueba sérica del embarazo con anterioridad a su entrada en el estudio. Todos los participantes, hombres y mujeres, aceptarán utilizar algún método anticonceptivo aceptable desde el punto de vista médico tanto en el transcurso del tratamiento como durante los seis meses siguientes a su finalización.
    E.4Principal exclusion criteria
    1. Tratamiento previo con PM01183.
    2. Diferenciación neuroendocrina o subtipo mucinoso en las pruebas histológicas.
    3. Más una línea previa de tratamiento sistémico por enfermedad avanzada.
    4. Metástasis cerebral documentada o afectación leptomeníngea.
    5. Enfermedades/condiciones concomitantes:
    a. Antecedentes o presencia en el último año de angina inestable, infarto de miocardio, insuficiencia cardiaca congestiva sintomática o fracción de eyección ventricular izquierda (FEVI) 45% (evaluada mediante ventriculografía nuclear [MUGA] o equivalente por ecografía [ECO]) o valvulopatía cardíaca clínicamente significativa.
    b. Edema generalizado y/o ascitis grado 3.
    c. Pacientes inmunocomprometidos, incluidos aquellos con infección por el virus de la inmunodeficiencia humana (VIH).
    d. Infección crónica activa por el virus de la hepatitis B (VHB) o de la hepatitis C (VHC).
    e. Infección activa no controlada.
    f. Miopatía o elevaciones persistentes de CPK > 2,5 x LSN en dos determinaciones distintas realizadas con una semana de diferencia.
    g. Limitación de la capacidad del paciente para cumplir con el tratamiento o el protocolo.
    h. Toda otra enfermedad importante que a juicio del investigador aumentaría considerablemente el riesgo asociado con la participación del paciente en este estudio.
    6. Trombosis venosa profunda (TVP) presente y no controlada.
    7. Hombres y mujeres en edad fértil que no estén usando un método anticonceptivo eficaz, como se mencionó anteriormente; mujeres embarazadas o en periodo de lactancia.
    8. Tratamiento con cualquier producto experimental en el periodo 5 semividas anterior a la primera infusión de PM01183.
    E.5 End points
    E.5.1Primary end point(s)
    Evaluar la actividad antitumoral de PM01183 en
    términos de supervivencia global a los 6 meses
    (SG6) en pacientes con cáncer de páncreas
    metastásico.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Cada 6 meses
    E.5.2Secondary end point(s)
    Supervivencia libre de progresión (SLP) a los tres (SLP3) y a los seis (SLP6) meses.
    • Tasa de respuesta según la versión 1.1 de RECIST y duración de la respuesta.
    • Evolución de los marcadores tumorales (CA19-9)
    • Supervivencia global (SG) y supervivencia global a los 12 meses (SG12).
    • Evaluación de seguridad
    • Análisis farmacocinético (FC).
    • Correlación farmacocinética/ farmacodinámica
    (FD/FD), si fuera pertinente.
    • Evaluación de la farmacogenómica (FGx) en
    muestras tumorales previamente disponibles /
    muestras de sangre extraídas antes del inicio del
    tratamiento con PM01183, con el fin de identificar posibles marcadores de sensibilidad o resistencia al fármaco.
    E.5.2.1Timepoint(s) of evaluation of this end point
    A lo largo de todo el estudio
    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 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) 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    La terminación prevista del estudio o fecha fin de estudio (FDE) (punto de corte clínico) será nueve meses después de la fecha del final del tratamiento del último paciente (última visita del último paciente), o doce meses después de la inclusión del último paciente (lo que ocurra primero).
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    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.1.1Number of subjects for this age range: 0
    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: 28
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 43
    F.4.2.2In the whole clinical trial 43
    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)
    No aplicable.
    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 Decision2011-05-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-06
    P. End of Trial
    P.End of Trial StatusOngoing
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