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    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.
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    Summary
    EudraCT Number:2015-002395-24
    Sponsor's Protocol Code Number:PM60184-B-001-15
    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
    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 number2015-002395-24
    A.3Full title of the trial
    Phase II, Open-Label, Randomized, Controlled Study of PM060184 in Advanced, Hormone Receptor Positive, HER2 negative Breast Cancer Patients in Third or Fourth Line Setting.
    Estudio de fase II, abierto, randomizado y controlado de PM060184 en pacientes con cáncer de mama avanzado, receptores hormonales positivos y HER 2 negativo en tercera o cuarta línea.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II study of PM060184 in Advanced Breast Cancer Patients in Third or Fourth Line.
    Estudio de fase II de PM060184 en pacientes con cáncer de mama avanzado en tercera o cuarta línea.
    A.4.1Sponsor's protocol code numberPM60184-B-001-15
    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 pointClinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressAvda 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 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 namePM060184
    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 INNNot Aplicable
    D.3.9.1CAS number 960210-99-5
    D.3.9.2Current sponsor codePM060184
    D.3.9.3Other descriptive namePM060184
    D.3.9.4EV Substance CodeSUB31670
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 RoleComparator
    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.2.5The 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 Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCapecitabine
    D.3.9.3Other descriptive nameCAPECITABINE
    D.3.9.4EV Substance CodeSUB12474MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVINORELBINE TARTRATE
    D.3.9.1CAS number -
    D.3.9.3Other descriptive nameVINORELBINE
    D.3.9.4EV Substance CodeSUB20777
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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: 4
    D.1.2 and D.1.3IMP RoleComparator
    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 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 INNVINORELBINE TARTRATE
    D.3.9.1CAS number -
    D.3.9.4EV Substance CodeSUB20777
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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: 5
    D.1.2 and D.1.3IMP RoleComparator
    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 Concentrate and solvent 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 INNdocetaxel
    D.3.9.3Other descriptive nameDOCETAXEL
    D.3.9.4EV Substance CodeSUB12492MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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: 6
    D.1.2 and D.1.3IMP RoleComparator
    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 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 INNPACLITAXEL
    D.3.9.1CAS number 33069-62-4
    D.3.9.4EV Substance CodeSUB09583MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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: 7
    D.1.2 and D.1.3IMP RoleComparator
    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 Powder for suspension for injection
    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 INNpaclitaxel
    D.3.9.3Other descriptive namePACLITAXEL ALBUMIN-BOUND
    D.3.9.4EV Substance CodeSUB127678
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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: 8
    D.1.2 and D.1.3IMP RoleComparator
    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 Solution for injection
    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 INNeribulin
    D.3.9.1CAS number 441045-17-6
    D.3.9.3Other descriptive nameERIBULIN MESYLATE
    D.3.9.4EV Substance CodeSUB31126
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.44
    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: 9
    D.1.2 and D.1.3IMP RoleComparator
    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 Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcapecitabine
    D.3.9.3Other descriptive nameCAPECITABINE
    D.3.9.4EV Substance CodeSUB12474MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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: 10
    D.1.2 and D.1.3IMP RoleComparator
    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 Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcapecitabine
    D.3.9.3Other descriptive nameCAPECITABINE
    D.3.9.4EV Substance CodeSUB12474MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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: 11
    D.1.2 and D.1.3IMP RoleComparator
    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 Capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVINORELBINE TARTRATE
    D.3.9.3Other descriptive nameVinorelbine
    D.3.9.4EV Substance CodeSUB20777
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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.IMP: 12
    D.1.2 and D.1.3IMP RoleComparator
    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 Concentrate and solvent 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 INNdocetaxel
    D.3.9.3Other descriptive nameDOCETAXEL
    D.3.9.4EV Substance CodeSUB12492MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    Breast Cancer
    Cancer de mama
    E.1.1.1Medical condition in easily understood language
    Breast Cancer
    Cancer de mama
    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 LLT
    E.1.2Classification code 10072737
    E.1.2Term Advanced breast cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To Evaluate the efficacy of PM060184 in terms of progression-free survival at 4 months (PFS4) in third or fourth line setting in the subset population of advanced, hormone receptor positive, human epidermal growth factor receptor 2 (HER2) negative, breast carcinoma
    Determinar la eficacia del PM060184 en relación con la supervivencia libre de progresión a los cuatro meses (SLP4) como tratamiento de tercera o cuarta línea en pacientes de carcinoma de mama avanzado, receptores hormonales positivos y negativo para receptor 2 del factor de crecimiento epidérmico humano (HER2)
    E.2.2Secondary objectives of the trial
    Evaluate the feasibility of administering PM060184 in shorter administration times.
    Evaluate (OS), median (PFS), (ORR) and (DR), as defined by RECIST.
    Characterize the safety profile and feasibility of PM060184 treatment in this population.
    Describe the peripheral neuropathy profile at (BL) and over time using a patient reported outcome questionnaire (the EORTC-QLQ-CIPN20).
    Characterize the (PK) of PM060184 in this subset of patients.
    Characterize the metabolomics of PM060184, i.e., systemic variations in the patients pre- and post-treatment metabolic profile that allow the identification of potential biomarkers of PK, safety and/or efficacy response to PM060184.
    Characterize the (PGt) of PM060184, i.e., the presence or absence of germline mutations or polymorphisms that may help explain individual variability in the main PK parameters and safety outcomes.?Analyze the (PGx) of PM060184, i.e., potential predictive factors of sensitivity/resistance to PM060184 treatment.
    Evaluar la viabilidad de reducir tiempos de administración de PM060184.
    Evaluar supervivencia global (SG), mediana de supervivencia libre progresión (SLP), tasa respuesta global (TRG) y duración de respuesta (DR) según RECIST v.1.1.
    Establecer perfil de seguridad y viabilidad del tratamiento.
    Describir perfil de neuropatía periférica al inicio del estudio y a lo largo del tiempo utilizando un cuestionario de resultados por el paciente.
    Farmacocinética (FC) de PM060184.
    Metabolómica de PM060184, es decir, variaciones en el perfil metabólico que permitan identificar biomarcadores, seguridad y/o eficacia en la respuesta.
    Farmacogenética (PGt) del PM060184, es decir, la presencia o ausencia de mutaciones o polimorfismos en la línea germinal que puedan explicar la variabilidad individual en los parámetros farmacocinéticos y resultados de seguridad.
    Farmacogenómica (PGx) dl PM060184, es decir, posibles factores predictivos de sensibilidad/resistencia al tratamiento.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacogenomics (PGx), Pharmacogenetics (PGt) and Metabolomic Biomarkers.
    Sub-estudio de Farmacogenómica, Pharmacogenética y Metabolómica.
    E.3Principal inclusion criteria
    1) Voluntarily written informed consent (IC), obtained from the patient
    before the beginning of any specific study procedures.
    2) Age ≥ 18 years.
    3) Histologically proven diagnosis of breast cancer.
    4) Tumors must be hormone receptor (ER and/or PgR) positive and
    HER2 negative.
    5) Two or three chemotherapy lines in the advanced setting (adjuvant
    and/or neoadjuvant chemotherapy are allowed).
    6) Previous treatment with anthracyclines and taxanes (unless clinically
    contraindicated for any of them).
    7) Disease progression should have occurred within 2 months before
    study entry and within 6 months of the last administration of
    chemotherapy for advanced disease.
    8) Measurable disease as defined by the RECIST criteria v.1.1. If the only
    tumor lesion is situated in a previously irradiated area, or in an area
    subjected to other loco-regional therapy, progression of the lesion must
    be demonstrated.
    9) Patients with dermic metastatic pattern only: lesions should have at
    least 10 mm diameter assessed by calipers and should be documented
    by color photography including a ruler to estimate the size of the lesion.
    10) Patients with bone metastases will be eligible if other sites of
    measurable disease are present.
    11) Eastern Cooperative Oncology Group (ECOG) performance status
    (PS) 0 or 1.
    12) For patients in both arms, adequate bone marrow, liver and kidney
    function:
    a) Hemoglobin ≥ 9 g/dl.
    b) Neutrophil count ≥ 1.5 × 109/l.
    c) Platelet count ≥ 100 × 109/l.
    d) Serum creatinine ≤ 1.5 mg/dl or calculated creatinine clearance ≥ 40
    ml/min.
    e) Albumin ≥ 2.5 g/dl.
    f) Total serum bilirubin ≤ 1.5 x upper limit of normal (ULN), except in
    case of Gilbert´s syndrome.
    g) Alanine aminotransferase (ALT) and aspartate aminotransferase
    (AST) ≤ 3 × ULN (≤ 5.0 x ULN in the presence of liver metastases).
    13) Peripheral neuropathy grade ≤ 1 according to the National Cancer
    Institute Common Terminology Criteria for the Classification of Adverse
    Events (NCI-CTCAE) (v.4).
    14) Complete recovery to grade ≤ 1 from any toxicity due to a previous
    therapy (except for alopecia) according to the NCI-CTCAE (v.4) criteria.
    15) Left ventricular ejection fraction (LVEF) by echocardiography (ECHO)
    or multiple-gated acquisition (MUGA) scan within normal range
    (according to institutional standards).
    16) At least three weeks since the last administration of chemotherapy,
    biological therapy or investigational drug; six weeks since the last
    administration of nitrosoureas and mitomycin C, and one week since the
    last dose of hormone-therapy.
    17) At least three weeks since the end of radiotherapy involving up to
    35% of the bone marrow (radiotherapy involving > 35% of bone
    marrow is not allowed) or two weeks since the end of palliative
    radiotherapy, including single doses.
    18) Life expectancy ≥ 3 months.
    19) Women of child-bearing potential must have a negative pregnancy
    test seven days prior to treatment administration; a medically approved
    method of contraception must be maintained while on treatment with
    any of the trial medications and for six months after their last
    administration. Peri-menopausal women must have had amenorrhea for
    at least 12 months to be considered of non-childbearing potential.
    1)Consentimiento informado voluntario y por escrito, antes de realizar
    cualquier procedimiento específico del estudio.
    2) Edad ≥ 18 años.
    3) Pacientes con diagnóstico histológico confirmado de cáncer de mama.
    4) Pacientes con tumores receptores hormonales positivos (RE y/o RPg)
    y HER 2 negativos.
    5) Dos o tres líneas de quimioterapia para enfermedad avanzada (se
    permiten las quimioterapias adyuvantes y/o neoadyuvantes).
    6) Tratamiento previo con antraciclinas y taxanos (salvo quealguno de
    ellos esté contraindicado).
    7) Progresión de la enfermedad en los dos meses anteriores a la
    inclusión en el estudio y en los seis meses posteriores a la última dosis
    de quimioterapia para enfermedad avanzada.
    8) Enfermedad medible según los criterios de evaluación de la respuesta
    en tumores sólidos (RECIST) v1.1. Si la única lesión tumoral se
    encuentra en un área irradiada con anterioridad o sujeta a cualquier otro
    tratamiento locorregional, se debe demostrar la progresión del tumor.
    9) Pacientes que presenten únicamente cuadro de metástasis cutáneas:
    las lesiones deben medirse con un calibre para garantizar que tienen un
    mínimo de 10 mm de diámetro y se deben documentar con fotografías en
    color que incluyan una regla para poder calcular el tamaño de la lesión.
    10) Los pacientes con metástasis óseas podrán incluirse en el estudio si
    hay otras zonas con enfermedad medible.
    11) Estado funcional (EF) 0 o 1 conforme a la escala del Eastern
    Cooperative Oncology Group (ECOG).
    12) Para pacientes incluidos en ambos grupos, función medular, renal,
    hepática y metabólica adecuadas:
    a) Hemoglobina ≥ 9 g/dl.
    b) Recuento de neutrófilos ≥ 1,5 × 109/l.
    c) Recuento plaquetario ≥ 100 × 109/l.
    d) Creatinina sérica ≤ 1,5 mg/dl o aclaramiento de creatinina calculado
    ≥ 40 ml/min.
    e) Albúmina ≥ 2,5 g/dl.

    f) Bilirrubina sérica total ≤ 1,5 x límite normal superior (LNS), excepto
    en los casos de síndrome de Gilbert.
    g) Alanino aminotransferasa (ALT) y aspartato aminotransferasa (AST)
    ≤ 3 × ULN (≤ 5,0 x LNS en los casos de metástasis hepáticas).
    13) Neuropatía periférica de grado ≤ 1 según los Criterios de
    terminología común para los efectos secundarios del National Cancer
    Institute (NCI-CTCAE) (v.4).
    14) Recuperación completa a grado ≤ 1 de cualquier acontecimiento
    adverso (AA) surgido a partir de un tratamiento previo (excepto
    alopecia) según los criterios del NCI-CTCAE (V.4).
    15) Fracción de eyección ventricular izquierda (FEVI) mediante
    ecocardiografía (ECO) o ventriculografía nuclear (MUGA) dentro de un
    intervalo normal (según las normas institucionales).
    16) Al menos tres semanas desde la última administración de
    quimioterapia, terapia biológica o fármacos en fase de investigación; un
    mínimo de seis semanas desde la administración de nitrosoureas y
    mitomicina C y al menos una semana desde la última dosis de
    tratamiento hormonal.
    17) Al menos tres semanas desde la finalización del tratamiento con
    radioterapia en un máximo del 35% de la médula ósea (queda excluida
    la radioterapia en > 35% de la médula ósea) o dos semanas desde la
    finalización de laradioterapia paliativa, incluso en dosis única.
    18) Esperanza de vida ≥ 3 meses.
    19) Las mujeres en edad fértil deben presentar una prueba de embarazo
    realizada siete días antes del tratamiento; se debe utilizar un método
    anticonceptivo aceptable desde un punto de vista médico a lo largo del
    periodo de tratamiento y durante seis meses después de la interrupción
    del mismo. Las mujeres premenopáusicas deben haber tenido amenorrea
    durante un mínimo de 12 meses para que se las considere en edad no
    fértil.
    E.4Principal exclusion criteria
    1) Prior exposure to PM060184.
    2) Concomitant administration of any other antineoplastic therapy.
    3) History of another neoplastic disease (except for prior breast cancer,
    basal cell carcinoma of the skin, properly treated in situ carcinoma of
    the uterine cervix, or melanoma in situ), unless in remission for five
    years or longer and without local or systemic recurrence.
    4) Presence of cerebral and/or leptomeningeal metastasis, even if they
    are being treated.
    5) Patients with locally advanced disease amenable to local therapy at
    study entry.
    6) Unknown HR status (both ER and PgR) and HER2 new status.
    7) Inflammatory breast carcinoma.
    8) Other serious and/or relevant diseases or clinical situations that, in
    the Investigator´s opinion, are incompatible with the protocol (any of
    the following):
    a) History of cardiac disease, such as myocardial infarction, in the year
    prior to enrollment in the clinical trial; symptomatic/uncontrolled angina
    pectoris; congestive heart failure or uncontrolled cardiac ischemia; any
    type of uncontrolled arrhythmia or abnormal left ventricular ejection
    fraction, or uncontrolled arterial hypertension (according to the
    standards of the World Health Organization, WHO).
    b) History of significant psychiatric disease.
    c) Active infection requiring antibiotic, antifungal or antiviral treatment
    that, in the opinion of the Investigator, could compromise the patient´s
    capacity to tolerate the therapy.
    d) Known active liver (hepatitis B or C or cirrhosis) or renal disease.
    e) Known human immunodeficiency virus (HIV) infection.
    f) Major surgery within the two weeks prior to entering the clinical trial
    or any other concomitant pathology that could jeopardize the patient´s
    safety or commitment to complete the clinical trial.
    9) Pregnant or breastfeeding women.
    10) Inability or refusal to comply with the protocol or with the clinical
    trial procedures.
    11) Known hypersensitivity to PM060184 or any of the drugs to be used
    in the PSPC arm (second stage).
    1) Exposición previa a PM060184.
    2) Administración concomitante de cualquier otro tratamiento
    antineoplásico.
    3) Antecedentes de otra enfermedad neoplásica (excepto cáncer de
    mama, carcinoma de piel de células basales, carcinoma de cuello uterino
    in situ debidamente tratado o melanoma in situ), a menos que haya
    estado en remisión por un periodo mínimo de cinco años y sin recaída
    local o sistémica.
    4) Metástasis cerebrales y/o leptomeníngeas, incluso aunque estén siendo tratadas.
    5) Pacientes con enfermedad localmente avanzada susceptible de ser tratada a nivel local en el momento de la inclusión en el estudio.
    6) Estado desconocido de RH (tanto RE como RPg) y nuevo estado de
    HER2.
    7) Carcinoma de mama inflamatorio.
    8) Cualquier otra enfermedad grave y/o importante que, a juicio del
    Investigador, sea incompatible con el protocolo (cualquiera de las que se
    indican a continuación):
    a) Antecedentes o presencia de cardiopatía, como infarto de miocardio,
    en el año anterior a su inclusión en el ensayo clínico; angina de pecho
    sintomática/no controlada; insuficiencia cardíaca congestiva o
    cardiopatía isquémica no controlada; cualquier tipo de arritmia no
    controlada o fracción de eyección ventricular izquierda anómala, o
    hipertensión arterial no controlada (de acuerdo con los estándares de la
    Organización Mundial de la Salud, OMS).
    b) Antecedentes de enfermedad psiquiátrica significativa.
    c) Infección activa que precise tratamiento con antibióticos, antifúngicos
    o antivirales que, a juicio del Investigador, pueda comprometer la
    capacidad del paciente para tolerar el tratamiento.
    d) Enfermedad hepática (hepatitis B o C o cirrosis) o renal activa y
    conocida.
    e) Infección conocida por el virus de la inmunodeficiencia humana (VIH).
    f) Cirugía mayor en las dos semanas anteriores a su inclusión en el
    ensayo clínico o cualquier otra patología concomitante que pudiera
    poner en peligro la seguridad del paciente o su compromiso de completar el ensayo clínico.
    Mujeres embarazadas o en periodo de lactancia.
    10) Incapacidad para o rechazo a cumplir con el protocolo o los
    procedimientos del ensayo clínico.
    11) Hipersensibilidad conocida a PM060184 o a cualquier fármaco
    utilizado en el grupo EMSP (segunda fase).
    E.5 End points
    E.5.1Primary end point(s)
    For efficacy if they are eligible and have received at least one treatment cycle with PM060184/PSPC and have undergone at least one radiological post-BL evaluation (performed a minimum of eight weeks ± 1 week from the first drug administration).
    Se evaluará la eficacia en los pacientes si cumplen los criterios y han recibido al menos un ciclo de tratamiento con PM060184/EMSP y se les ha realizado al menos una evaluación radiológica posterior al IE (realizado transcurridas un mínimo de 8 semanas ± 1 semana desde la primera administración del fármaco).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Along the study.
    A lo largo del estudio.
    E.5.2Secondary end point(s)
    Efficacy, Safety, Peripheral neurophaty, Pharmacokinetics, Metabolomic, Pharmacogenetic, Pharmacogenomic
    Eficacia, Seguridad, Neuropatía periférica, Farmacocinética, Metabolómica, Farmacogenética, Farmacogenómica,
    E.5.2.1Timepoint(s) of evaluation of this end point
    Along the study
    A lo largo del 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 Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Metabolomic
    Metabolómica
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    First stage: Four months after the first administration of the last evaluable patient recruited if the trial is stopped at the first stage.
    Second stage: Twelve months after the first administration of the last patient treated in the experimental arm.
    Primera fase: cuatro meses después de la primera administración del último paciente evaluable reclutado si el ensayo se detiene en la primera etapa. Segunda etapa: doce meses después de la primera administración del último paciente tratados en el brazo experimental.
    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 months8
    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 months8
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 26
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 106
    F.4.2.2In the whole clinical trial 106
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-12-09
    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 trial2017-10-30
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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