Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   31566   clinical trials with a EudraCT protocol, of which   5087   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2011-006108-11
    Sponsor's Protocol Code Number:PM1183-B-003-11
    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:2012-02-10
    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 number2011-006108-11
    A.3Full title of the trial
    A Multicenter Phase II Clinical Trial of PM01183 in BRCA 1/2-Associated or Unselected Metastatic Breast Cancer.
    Ensayo Clínico de fase II, multicéntrico de PM01183 en cáncer de mama metastásico no seleccionado o asociado a las mutaciones BRCA1 y BRCA2.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase II Clinical Trial of PM01183 in BRCA 1/2-Associated or Unselected Metastatic Breast Cancer.
    Ensayo Clinico de Fase II de PM01183 en Cáncer de Mama Metastático Asociado o No a Mutación de Genes BRCA-1/2
    A.3.2Name or abbreviated title of the trial where available
    N.A.
    N.A.
    A.4.1Sponsor's protocol code numberPM1183-B-003-11
    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.
    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.
    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.
    B.5.2Functional name of contact pointClinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressAvda. De Los Reyes, no 1 Pol. Ind. La Mina
    B.5.3.2Town/ cityColmenar Viejo (Madrid)
    B.5.3.3Post code28770
    B.5.3.4CountrySpain
    B.5.4Telephone number3491846 60 00
    B.5.5Fax number3491846 60 03
    B.5.6E-mailclinicaltrials@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.3.9.1CAS number 497871-47-3
    D.3.9.2Current sponsor codePM01183
    D.3.9.3Other descriptive namePM01183
    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.3.9.1CAS number 497871-47-3
    D.3.9.2Current sponsor codePM01183
    D.3.9.3Other descriptive namePM01183
    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
    BRCA1 / BRCA2 associated or unselected Metastatic Breast Cancer.
    Cáncer de mama metastático no seleccionado o asociado a las mutaciones BRCA1 y BRCA2.
    E.1.1.1Medical condition in easily understood language
    Metastatic Breast Cancer.
    Cáncer de mama metastático.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10027475
    E.1.2Term Metastatic breast cancer
    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 the antitumor activity of PM01183 in terms of overall response rate (ORR) according to RECIST vs 1.1 in each cohort of metastatic breast cancer (MBC) patients.
    Evaluar la actividad antitumoral de PM01183 en términos de tasa de respuesta global (TRG), de acuerdo con la versión 1.1 de RECIST, en cada cohorte de pacientes con cáncer de mama metastásico (CMM).
    E.2.2Secondary objectives of the trial
    Characterize the antitumor activity of PM01183 in terms of duration of response (DR) clinical benefit, progression free survival (PFS) and one-year overall survival (ly-OS) /Evaluate whether the presence of a known germline mutation in BRCA 1/2 predicts response of PM01183 in MBC patients/Explore activity of PM01183 in specific breast cancer subpopulations/ Evaluate safety profile of PM01183/Explore PK/PD correlations if applicable/Evaluate PGx expression.
    ?Realizar una caracterización adicional de la actividad antitumoral de PM01183 respecto a la duración de la respuesta (DR), el beneficio clínico [TRG o enfermedad estable de más de tres meses de duración (EE > 3 meses)], la supervivencia libre de progresión (SLP), y la supervivencia global a un año (SG-1a).
    ?Evaluar si la presencia de una mutación germinal conocida en BRCA 1/2 predice la respuesta a PM01183 en pacientes con CMM.
    ?Explorar la actividad de PM01183 en subpoblaciones específicas con cáncer de mama
    ?Evaluar el perfil de seguridad de PM01183
    ?Analizar el perfil farmacocinético.
    ?Explorar las correlaciones FC/ FD si aplica.
    ?Evaluar el perfil farmacogenómico (PGx) de expresión de los supuestos marcadores potencialmente predictivos de la respuesta a PM01183.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Women>=18 and <=75 years of age/Voluntary signed informed consent form before any study procedure/Histologically proven diagnosis of metastatic breast carcinoma/ At least one, but no more than three, prior chemotherapy-containing regimens for MBC/Patients with known HER-2 overexpressing tumors must have failed at least one prior trastuzumab-containing regimen for metastatic disease/Measurable disease as defined by RECIST v1.1/ECOG performance status 0 or 1/Adequate major organ function/Wash out periods prior to Day 1 of Cycle 1/Grade <=1 toxicity due to any previous cancer therapy according to NCI-CTCAE/ Patients of child-bearing potental must agree to use a medically approved contraception method until at least six weeks after the last study drug administration.
    Patients in Cohort A: Known deleterius germline mutation of BRCA 1/2.
    1.Mujeres ? 18 y ? 75 años de edad.
    2. Formulario de consentimiento informado firmado voluntariamente, obtenido antes de cualquier procedimiento específico del estudio.
    3.Diagnóstico de cáncer de mama metastásico demostrado mediante pruebas histológicas.
    4.Al menos uno, pero no más de tres, tratamientos con quimioterapia para CMM.
    5.Las pacientes con tumores con sobreexpresión de HER-2 conocida deben haber presentado fracaso terapéutico al menos en un tratamiento previo con trastuzumab para la enfermedad metastásica.
    6.Enfermedad cuantificable definida por la versión 1.1 de RECIST.
    7.Estado funcional (EF) en la escala ECOG de 0 ò 1.
    8.Funcionamiento adecuado de los órganos vitales.
    9.Periodos de lavado farmacológico antes del Día 1 del primer ciclo.
    10.Toxicidad de grado ? 1 debida a cualquier tratamiento antitumoral previo de acuerdo con los Criterios de NCI-CTCAE. 11.Las pacientes en edad fértil deben acordar utilizar un método anticonceptivo aprobado desde el punto de vista médico hasta al menos seis semanas después de la última administración del fármaco del estudio.
    Pacientes en la Cohorte A
    12.Mutación germinal deletérea conocida en BRCA1/2.
    E.4Principal exclusion criteria
    Prior treatment with PM01183 or trabectedine/Prior RT in more than 35% of the bone marrow/ Prior or concurrent malignant disease unless in complete remission for more than five years/Histology other than ductal or lobulillar carcinoma of the breast/Symptomatic , steroid requiring or progressive central nervous system (CNS) involvement/Exclusively bone-limited disease/Relevant diseases or clinical situations which may increase patient´s risk/ Pregnant or breastfeeding women/ Impending need for RT/Limitation of the patient´s ability to comply with the treatment or to follow-up the protocol.
    Patients in Cohort B: Known deleterius germline mutation of BRCA 1/2.
    1.Tratamiento previo con PM01183 o trabectedina.
    2.RT previa en más del 35% de la médula ósea.
    3.Enfermedad maligna previa o concurrente a menos que presente remisión completa durante más de cinco años.
    4.Histología distinta del cáncer de mama ductal o lobulillar.
    5.Afectación sintomática del sistema nervioso central (SNC) progresiva o que requiere esteroides.
    6.Enfermedad limitada exclusivamente al hueso.
    7.Enfermedades o situaciones clínicas relevantes que pueden aumentar el riesgo de la paciente.
    8.Mujer embarazada o en periodo de lactancia.
    9.Necesidad inminente de RT.
    10.Limitación de la capacidad de la paciente para cumplir con el tratamiento o para seguir el protocolo.
    Pacientes en la Cohorte B: Mutación germinal deletérea conocida en BRCA1/2.
    E.5 End points
    E.5.1Primary end point(s)
    Overall response rate (ORR), according to RECIST v.1.1, in each cohort of metastatic breast cancer (MBC) patients.
    ?Tasa de respuesta global (TRG), de acuerdo con los criterios de la versión 1.1 de RECIST.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Timepoint (TP): Minimum 10-12 months if negative results and up to 26-28 months if study is to be complete the targeted enrollment.
    Momento de la evaluación: Mínimo 10-12 meses si los resultados son negativos y hasta 26-28 meses si se completa el objetivo de reclutamiento del estudio.
    E.5.2Secondary end point(s)
    Duration of response (DR)/ Clinical benefit, defined as the percentage of patients with ORR or SD> 3 months, according to RECIST v1.1/Progression-free survival (PFS)/ Overall survival rate at one year (1y-OS)/ Treatment safety/PK analysis and PK/PD correlation, if applicable/ PGx expression profile.
    ?Duración de la respuesta (DR).
    ?Beneficio clínico, definido como el porcentaje de pacientes con TRG o EE > 3 meses, de acuerdo con los criterios de la versión 1.1 de RECIST.
    ?Supervivencia libre de progresión (SLP).
    ?Tasa de supervivencia global en un año (SG-1a).
    ?Seguridad del tratamiento: los AA, AA graves (AAG) y las anomalías de laboratorio se clasificarán de acuerdo con la versión 4 del NCI-CTCAE.
    ?Los análisis FC y la correlación entre FC/FD, en caso necesario.
    ?El perfil de expresión PGx, en los tejidos de las muestras tumorales archivadas.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Duration of response (DR). TP: 36 months
    Clinical benefit, defined as the percentage of patients with ORR or SD > 3 months, according to RECIST v1.1. (TP:29-32 months)
    Progression-free survival (PFS). TP: 36 months
    Overall survival rate at one year (1y-OS). 36 months
    Treatment safety: AEs, serious AEs (SAEs) and laboratory abnormalities will be graded according to the NCI-CTCAE (v4). (25-26 months)
    PK analysis and PK/PD correlation, if applicable. 36 months approximately
    PGx expression profile, in tissues from archived tumor samples: 36 months
    Duración de la respuesta (DR). Momento de la evaluación: 36 meses de beneficio clínico, definido como el porcentaje de pacientes con RC o SD> 3 meses, de acuerdo a RECIST vs 1.1 (TP: 29-32 meses)/Supervivencia libre de progresión (PFS). Momento de la evaluación: 36 meses/ Índice de supervivencia al año (1y-OS): 36 meses/ Seguridad: AEs, Acontecimientos adversos (SAEs) y anormalidades de laboratorio serán evaluadas de acuerdo a NCI-CTCAE (v4): 25-26 meses.
    Análisis de PK y correlación entre PK/PD, si aplicase: 36 meses aproximadamente.
    Expresión del perfil PGx en tejidos de muestras tumorales: 36 meses.
    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 No
    E.8.1.2Open No
    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) 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 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
    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
    Nine months after the last patient-last treatment visit in the study, or 12 months after the last evaluable patient is enrolled (whichever occurs first).
    Nueve meses después del último tratamiento del último paciente en el estudio, o 12 meses después de que el último paciente evaluable haya sido reclutado (lo que ocurra primero).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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: 42
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 117
    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)
    Not applicable.
    Not applicable.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-04-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-23
    P. End of Trial
    P.End of Trial StatusOngoing
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-Wed Nov 22 08:58:48 GMT 2017 | 30 Churchill Place, Canary Wharf, London E14 5EU
    Legal notice
    EMA HMA