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    Summary
    EudraCT Number:2015-002395-24
    Sponsor's Protocol Code Number:PM60184-B-001-15
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-05-11
    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 ConcernedBelgium - FPS Health-DGM
    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.
    Etude de phase II ouverte, randomisée et contrôlée du produit PM060184 chez des patients du cancer du sein à un stade avancé, avec récepteurs hormonaux positifs, HER2 négatif, en troisième ou quatrième ligne
    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.
    Etude de phase II du produit PM060184 chez des patients du cancer du sein en troisième ou quatrième ligne.
    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.
    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, 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 AuthorisationBelgium
    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: 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 AuthorisationBelgium
    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: 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 AuthorisationBelgium
    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: 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.2.5The 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: 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.2.5The 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: 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.2.5The 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: 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.2.5The 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: 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 AuthorisationBelgium
    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 du sein
    E.1.1.1Medical condition in easily understood language
    Breast Cancer
    Cancer du sein
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    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
    Evaluer l'activité du produit PM060184 en terme de survie
    sans progression à 4 mois (SSP4) en troisième ou quatrième
    ligne de traitement dans une sous-population de patients
    atteints du cancer du sein à un stade avancé avec récepteurs
    hormonaux positifs, récepteur du facteur de croissance
    épithéliale humaine 2 (HER2) négatif.
    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.
    Evaluer la faisabilité de l’administration du PM060184 sur de plus courtes durées. Evaluer la SG, la SSP médiane, le TRG et la DdR tels que définis par les critères RECIST. Caractériser le profil de tolérance et la faisabilité du traitement par PM060184 au sein de cette population. Décrire le profil de neuropathie périphérique au cours du traitement à l’aide d’un questionnaire rempli par les patients (EORTC-QLQ-CIPN20). Caractériser la PK du PM060184 au sein de cette sous-population de patients. Caractériser la métabolomique du PM060184,c’est-à-dire les
    variations systémiques du profil métabolique des patients avant et après traitement, ce qui permettra l’identification de biomarqueurs potentiels pour la réponse au PM060184 en termes de PK, d’innocuité et/ou d’efficacité. Caractériser la la pharmacogénétique (PGt) du PM060184. Analyser la pharmacogénomique (PGx) du PM060184, c’est –à-dire les facteurs potentiels de prédiction de sensibilité/résistance au traitement avec le PM060184.
    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.
    Etude secondaire de pharmacogénomique (PGx) et de
    pharmacogénétique (PGt) et de Métabolomique (biomarqueurs).

    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) Signature libre et volontaire du formulaire de consentement éclairé (FCE) volontaire par écrit, avant le début de toute procédure spécifique à l'étude.
    2) Âge ≥ 18 ans.
    3) Diagnostic de cancer du sein confirmé par histologie.
    4) Tumeurs avec récepteurs hormonaux (RO et/ou RPg)
    positifs et HER2 négatif.
    5) Deux ou trois lignes de chimiothérapie au stade avancé
    (chimiothérapie adjuvante et/ou néo-adjuvante sont autorisées).
    6) Traitement antérieur par anthracyclines et taxanes (sauf
    contre-indication clinique).
    7) Progression de la maladie dans les deux mois précédent
    l’entrée dans l’étude et dans les six mois suivant la
    dernière administration de chimiothérapie pour la maladie
    avancée.
    8) Maladie mesurable, telle que définie par les critères
    RECIST v.1.1. Si la seule lésion se situe dans une zone
    précédemment traitée par irradiation ou dans une zone
    soumise à un autre traitement loco-régional, la
    progression de la lésion doit être démontrée.
    9) Patients avec propagation métastatique cutanée
    uniquement : les lésions doivent mesurer au moins 10 mm
    de diamètre (mesure par compas) et doivent être
    documentées à l’aide de photographies en couleurs
    comportant une règle permettant d’en estimer la taille.
    10) Patients avec métastases osseuses : sont éligibles si
    présence d’autres sites où la maladie est mesurable.
    11) Performance Status (PS) selon les critères de l’ECOG
    (Eastern Cooperative Oncology Group) de 0 ou 1.
    12) Pour les patients des deux groupes, fonctions médullaires,
    hépatiques et rénales adéquates :
    a) Hémoglobine ≥ 9 g/dl.
    b) Numération des neutrophiles ≥ 1,5 × 109/l.
    c) Numération plaquettaire ≥ 100 × 109/l.
    d) Créatinine sérique ≤ 1,5 mg/dl ou clairance calculée de
    la créatinine ≥ 40 ml/min.
    e) Albumine ≥ 2,5 g/dl.
    f) Bilirubine sérique totale ≤ 1,5 x la limite supérieure de
    normalité (LSN), sauf en cas de syndrome de Gilbert.
    g) Alanine aminotransférase (ALAT) et aspartate
    aminotransférase (ASAT) ≤ 3 x LSN (≤ 5,0 x LSN si
    présence de métastases hépatiques).
    13) Neuropathie périphérique de grade ≤ 1 selon la version 4
    des critères terminologiques communs pour la
    classification des évènements indésirables de l'institut
    national du cancer (National Cancer Institute Common
    Terminology Criteria for the Classification of Adverse
    Events (NCI-CTCAE v4).
    14) Récupération totale au grade ≤ 1 de toute toxicité due à un
    traitement antérieur (sauf alopécie) selon les critères NCICTCAE
    (v.4).
    15) Fraction d’éjection du ventricule gauche (FEVG),
    mesurée par échocardiogramme doppler (ECHO) ou
    isotopique (MUGA), dans les valeurs normales selon les
    normes institutionnelles.
    16) Délai minimum de trois semaines depuis la dernière
    chimiothérapie, thérapie biologique ou administration de
    traitement expérimental ; six semaines depuis la dernière
    administration de nitrosourées et de mitomycine C ; et
    une semaine depuis la dernière dose d’hormonothérapie.
    17) Délai minimum de trois semaines depuis la fin de la
    radiothérapie touchant au maximum 35 % de la moelle
    osseuse (les radiothérapies touchant > 35 % de la moelle
    osseuse ne sont pas acceptables) ou deux semaines depuis
    la fin de la radiothérapie palliative, y compris en dose
    unique.
    18) Espérance de vie ≥ 3 mois.
    19) Les femmes susceptibles de procréer doivent avoir un test
    de grossesse négatif dans les sept jours précédant
    l’administration du traitement. Il est impératif d’utiliser
    une méthode contraceptive médicalement validée pendant
    la durée de traitement avec l’un des produits concernés par l’étude, et pendant les six mois suivants la dernière
    administration. Les femmes en péri-ménopause doivent
    avoir eu au minimum 12 mois d’aménorrhée pour n’être
    plus considérées comme étant potentiellement en mesure
    de procréer.
    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) Traitement antérieur par PM060184.
    2) Administration concomitante d’un autre traitement
    antinéoplasique.
    3) Antécédents d’autre maladie néoplasique (sauf
    antécédents de cancer du sein, carcinome basocellulaire,
    carcinome in situ du col utérin correctement traité ou
    mélanome in situ) à moins qu’elle ne soit en rémission
    depuis cinq ans ou plus et sans récurrence locale ou
    systémique.
    4) Présence de métastases cérébrales et/ou leptoméningées,
    même si elles sont traitées.
    5) Patients avec une maladie avancée au niveau local et
    réceptive à un traitement local au moment de l’admission
    à l’étude.
    6) État RH (RO et RPg) et HER2 inconnu.
    7) Cancer inflammatoire du sein.
    8) Autres maladies ou situations cliniques graves et/ou
    significatives qui sont, d’après l’Investigateur,
    incompatibles avec le protocole (tous les cas suivants) :
    a) Antécédents de maladies cardiaques, comme l’infarctus
    du myocarde, au cours de l’année précédant l’inclusion
    dans l’essai clinique ; angine de poitrine
    symptomatique/non contrôlée ; insuffisance cardiaque
    congestive ou ischémie myocardique non contrôlée ;
    tous types d’arythmie non contrôlée, de fraction
    d’éjection du ventricule gauche anormale, ou
    d’hypertension non contrôlée (selon les critères de
    l’Organisation mondiale de la santé, OMS).
    b) Antécédents de troubles psychiatriques significatifs.
    c) Infection évolutive nécessitant un traitement
    antibiotique, antifongique ou antiviral qui pourrait,
    selon l’Investigateur, compromettre la capacité du
    patient à tolérer le traitement.
    d) Maladie hépatique (hépatite B, C ou cirrhose) ou rénale
    évolutive connue.
    e) Infection connue par le virus de l’immunodéficience
    humaine (VIH).
    f) Intervention chirurgicale majeure au cours des deux
    semaines précédant l’entrée dans l’essai clinique, ou
    toute autre pathologie concomitante pouvant mettre la
    santé du patient en danger ou nuire à son implication
    dans l’essai clinique.
    9) Femmes enceintes et/ou allaitantes.
    10) Incapacité à ou refus de suivre le protocole ou les
    procédures inhérentes à l’essai clinique.
    11) Hypersensibilité connue au produit PM060184 ou à l’un
    des médicaments utilisés pour le groupe CMCP
    (deuxième phase).
    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).
    L’efficacité du traitement pourra être évaluée chez les patients, à
    condition qu’ils soient éligibles et qu'ils aient suivi au minimum
    un cycle de traitement avec PM060184/CMSP et qu’ils aient
    passé au minimum une évaluation radiologique post-baseline
    (réalisée au moins huit semaines ± une semaine après la
    première administration de médicament).


    E.5.1.1Timepoint(s) of evaluation of this end point
    Along the study.
    Tout au long de l'étude.
    E.5.2Secondary end point(s)
    Efficacy, Safety, Peripheral neurophaty, Pharmacokinetics, Metabolomic, Pharmacogenetic, Pharmacogenomic
    Efficacité, sécurité, neuropathie périphérique, pharmacocinétique, métabolomique, pharmacogénétique, pharmacogénomique.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Along the study.
    Tout au long de l'étude.
    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
    Metabolomique
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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.
    Première partie:
    Quatre mois après la première administration chez le dernier patient recruté pouvant être évalué si l’essai est arrêté en première phase.
    Deuxième partie:
    Douze mois après la première administration chez le dernier patient traité dans le groupe expérimental.
    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 state15
    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
    Aucun
    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 Decision2016-06-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-25
    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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