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    The EU Clinical Trials Register currently displays   43876   clinical trials with a EudraCT protocol, of which   7294   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2018-001796-21
    Sponsor's Protocol Code Number:2102-ONC-102
    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:2019-01-22
    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 number2018-001796-21
    A.3Full title of the trial
    A Phase 1b/2 Study of FT-2102 in Patients with Advanced Solid Tumors and Gliomas with an IDH1 Mutation
    Estudio Fase 1b/2 de FT-2102 en pacientes con tumores sólidos avanzados y gliomas con mutación de IDH1
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of FT-2102 in Patients with Advanced Solid Tumors and Gliomas
    Estudio de FT-2102 en pacientes con tumores sólidos avanzados y gliomas.
    A.4.1Sponsor's protocol code number2102-ONC-102
    A.5.4Other Identifiers
    Name:US IND numberNumber:139611
    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 SponsorFORMA Therapeutics, Inc.
    B.1.3.4CountryUnited States
    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 supportFORMA Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFORMA Therapeutics, Inc.
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street Address500 Arsenal Street, Suite 100
    B.5.3.2Town/ cityWatertown, Massachusetts
    B.5.3.3Post code02472
    B.5.3.4CountryUnited States
    B.5.4Telephone number001617 679-1970
    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 nameFT-2102
    D.3.2Product code FT-2102
    D.3.4Pharmaceutical form Capsule, hard
    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 INNNot available
    D.3.9.2Current sponsor codeFT-2102
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFT-2102
    D.3.2Product code FT-2102
    D.3.4Pharmaceutical form Capsule, hard
    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 INNNot available
    D.3.9.2Current sponsor codeFT-2102
    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 RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Vidaza
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameAzacitidine
    D.3.4Pharmaceutical form Powder for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAZACITIDINE
    D.3.9.1CAS number 320-67-2
    D.3.9.2Current sponsor codeVidaza
    D.3.9.4EV Substance CodeSUB05624MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Opdivo
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameNivolumab
    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 INNNivolumab
    D.3.9.1CAS number 946414-94-4
    D.3.9.3Other descriptive nameNIVOLUMAB
    D.3.9.4EV Substance CodeSUB122750
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Opdivo
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameNivolumab
    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 INNNivolumab
    D.3.9.1CAS number 946414-94-4
    D.3.9.3Other descriptive nameNIVOLUMAB
    D.3.9.4EV Substance CodeSUB122750
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Opdivo
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameNivolumab
    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 INNNivolumab
    D.3.9.1CAS number 946414-94-4
    D.3.9.3Other descriptive nameNIVOLUMAB
    D.3.9.4EV Substance CodeSUB122750
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number240
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Gemcitabine
    D.2.1.1.2Name of the Marketing Authorisation holderAPSLA Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameGemcitabine
    D.3.4Pharmaceutical form Powder 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 INNGEMCITABINE
    D.3.9.1CAS number 95058-81-4
    D.3.9.4EV Substance CodeSUB07892MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Gemcitabine
    D.2.1.1.2Name of the Marketing Authorisation holderAPSLA Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameGemcitabine
    D.3.4Pharmaceutical form Powder 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 INNGEMCITABINE
    D.3.9.1CAS number 95058-81-4
    D.3.9.4EV Substance CodeSUB07892MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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 RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Cisplatin
    D.2.1.1.2Name of the Marketing Authorisation holderTeva UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameCisplatin
    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 INNCISPLATIN
    D.3.9.1CAS number 15663-27-1
    D.3.9.4EV Substance CodeSUB07483MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.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
    Advanced Solid Tumors and Gliomas with an IDH1 Mutation
    Tumores sólidos avanzados y gliomas con mutación IDH1
    E.1.1.1Medical condition in easily understood language
    Advanced Solid Tumors and Gliomas
    Tumores sólidos avanzados y gliomas
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10018338
    E.1.2Term Glioma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10008734
    E.1.2Term Chondrosarcoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10073073
    E.1.2Term Hepatobiliary cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10065252
    E.1.2Term Solid tumor
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10073077
    E.1.2Term Intrahepatic cholangiocarcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase 1b:
    Evaluate the safety and tolerability of FT-2102 as monotherapy and confirm the dose to be further examined in expansion cohorts as monotherapy and combination therapy.
    Phase 2:
    Evaluate the clinical activity of FT-2102 as monotherapy or in combination in patients with glioma, HBC, chondrosarcoma, and IHCC harboring an IDH1 mutation.
    Fase 1b:
    •Evaluar la seguridad y la tolerabilidad de FT-2102 en monoterapia y confirmar la dosis que se va a estudiar posteriormente en cohortes de ampliación en monoterapia y en combinación.
    Fase 2:
    •Evaluar la actividad clínica de FT-2102 en monoterapia o en combinación en pacientes con glioma, CHB, condrosarcoma y CCIH asociados a una mutación de IDH1.
    E.2.2Secondary objectives of the trial
    Phase 1b:
    Evaluate the PK of FT-2102 as monotherapy and in combination with other anti-cancer agents.
    Evaluate the clinical activity of FT-2102 as a single-agent or in combination in patients with glioma, HBC, chondrosarcoma, and IHCC harboring an IDH1 mutation.
    Phase 2:
    Evaluate the safety of FT-2102 administered as monotherapy and in combination in patients with glioma, HBC, chondrosarcoma, and IHCC harboring an IDH1 mutation.
    Evaluate the PK of FT-2102 as monotherapy and in combination with other anti-cancer agents.
    Evaluate additional measures of antitumor activity of FT-2102 as monotherapy and in combination with other anti-cancer agents.
    Fase 1b:
    •Evaluar la FC de FT-2102 en monoterapia y en combinación con otros fármacos contra el cáncer
    •Evaluar la actividad clínica de FT-2102 en monoterapia o en combinación en pacientes con glioma, CHB, condrosarcoma y CCIH asociados a una mutación de IDH1.
    Fase 2:
    •Evaluar la seguridad de FT-2102 administrado en monoterapia y en combinación en pacientes con glioma, CHB, condrosarcoma y CCIH asociados a una mutación de IDH1
    •Evaluar la FC de FT-2102 en monoterapia y en combinación con otros fármacos contra el cáncer
    •Evaluar medidas adicionales de la actividad antitumoral de FT-2102 en monoterapia y en combinación con otros fármacos contra el cáncer
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.≥18 years of age
    2.Life expectancy of ≥4 months
    3.Able to provide tumor tissue sample (archival)
    4.Disease, defined as:
    Disease-specific Cohorts
    •Glioma (Cohort 1)
    Histologically or cytologically confirmed IDH1 gene-mutated advanced glioma that has recurred or progressed following standard therapy, or that has not responded to standard therapy with measurable disease.
    Glioblastoma multiforme with confirmed IDH1 gene-mutated disease with first or second recurrence with measurable disease.
    HBC (Cohort 2)
    Relapsed/refractory or intolerant to approved standard-of-care therapy (included: hepatocellular carcinoma, bile duct carcinoma, intrahepatic cholangiocarcinoma or other hepatobiliary carcinomas)
    Histologically or cytologically confirmed IDH1 gene-mutated with measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
    Child-Pugh Class A
    Single Agent FT-2102: prior exposure to nivolumab is permitted
    Combination Cohort 2b: patients may not have had prior exposure to nivolumab.

    •Chondrosarcoma (Cohort 3)
    Relapsed or refractory and either locally advanced or metastatic and not amenable tocomplete surgical excision
    Histologically or cytologically confirmed IDH1 gene-mutated with measurabledisease per RECIST 1.1 criteria.
    •IHCC (Cohort 4)
    Advanced nonresectable or metastatic intrahepatic cholangiocarcinoma not eligiblefor curative resection or transplantation.
    Single-Agent/Safety Lead-in of Combination Phase 2: ineligible for standardtherapies only
    Combination Phase 2 (beyond Safety Lead-in): have received no more than 1 cycleof GemCis therapy
    Histologically or cytologically confirmed IDH1 gene-mutated with measurabledisease per RECIST 1.1 criteria
    •Other tumors (non-CNS) (Cohort 5)
    Relapsed or refractory to standard-of-care therapy with no other available therapeuticoptions
    Histologically or cytologically confirmed IDH1 gene-mutated with measurabledisease per disease appropriate response criteria.
    5.Recovered to ≤Grade 2 or baseline toxicity (except alopecia) from prior therapy (per CTCAEv 4.03)
    6.Eastern Cooperative Oncology Group (ECOG) performance status 0-2
    7.Adequate bone marrow function
    •Absolute neutrophil count (ANC) ≥1.5 x 109/L without any growth factors in prior7 days
    •Hemoglobin ≥8.0 g/dL (with or without transfusion support)
    Platelet count ≥75 × 109/L (with or without transfusion support); Cohort 4b (GemCiscombination): platelet count ≥100 × 109/L (with or without transfusion support)
    8.Adequate hepatic function
    •Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase)/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase) ≤2.5 ×institutional upper limit of normal (ULN). For patients with suspected malignancyrelated elevations, <5 × ULN.
    • Total bilirubin ≤1.5 × ULN. For patients with suspected malignancy related elevation <3 × institutional ULN.
    9. Adequate renal function
    • Creatinine clearance per Cockcroft-Gault equation of ≥60 mL/min
    10. For women of childbearing potential (WCBP): negative serum β human chorionic gonadotropin (β-hCG) pregnancy test within 1 week before first treatment (WCBP defined as a sexually mature woman who has not undergone surgical sterilization or who has not been naturally post-menopausal for at least 12 consecutive months for women >55 years of age)
    11. Willingness of male and female patients who are not surgically sterile or postmenopausal to use medically acceptable methods of birth control for the duration of the study treatment, including 90 days after the last dose of study drug. Sexually active men, and women using oral contraceptive pills, should also use barrier contraception. Males must agree not to donate sperm while participating in the study and for 90 days after the last dose of the study drug.
    12. Ability to adhere to the study visit schedule and all protocol requirements
    13. Signed and dated IRB/independent ethics committee (IEC)-approved informed consent form before any screening procedures are performed.
    1.18 años de edad como mínimo
    2.Esperanza de vida de ≥4 meses
    3.Capacidad de proporcionar muestras de tejido tumoral (de archivo)
    4.Enfermedad, definida como:
    Cohortes de enfermedades específicas
    •Glioma (Cohorte 1)
    •Glioma avanzado asociado a una mutación del gen IDH1 histológica o citológicamente confirmada, que ha reaparecido o progresado después del tratamiento de referencia, o que no ha respondido al tratamiento de referencia, con enfermedad mensurable.
    •Glioblastoma multiforme con enfermedad asociada a una mutación génica confirmada del gen IDH1 en la primera o segunda recidiva, con enfermedad mensurable.
    •CHB (Cohorte 2)
    •Recidivado/resistente o intolerante al tratamiento de referencia aprobado (incluidos: carcinoma hepatocelular, carcinoma de vías biliares, colangiocarcinoma intrahepático u otros carcinomas hepatobiliares)
    •Asociado a una mutación del gen IDH1 confirmada histológica o citológicamente con enfermedad mensurable según los Criterios de evaluación de la respuesta en tumores sólidos (Response Evaluation Criteria in Solid Tumors, RECIST) en su versión 1.1.
    •Clase A de Child-Pugh
    •FT-2102 en monoterapia: se permite la exposición previa a nivolumab
    •Cohorte de tratamiento combinado 2b: los pacientes pueden no haber recibido nivolumab con anterioridad
    •Condrosarcoma (Cohorte 3)
    •Recidivado o resistente al tratamiento y localmente avanzado o metastásico y no tributario de resección quirúrgica completa
    •Asociado a una mutación del gen IDH1 confirmada histológica o citológicamente con enfermedad mensurable según los criterios RECIST en su versión 1.1.
    •CCIH (Cohorte 4)
    •Colangiocarcinoma intrahepático avanzado, irresecable o metastásico no elegible para resección curativa o trasplante.
    •Preinclusión de seguridad en monoterapia/de la fase 2 de combinación: no elegible para los tratamientos de referencia únicamente
    •Fase 2 de combinación (más allá de la preinclusión de seguridad): no haber recibido más de 1 ciclo de tratamiento con GemCis
    •Asociado a una mutación del gen IDH1 confirmada histológica o citológicamente con enfermedad mensurable según los criterios RECIST en su versión 1.1.
    •Otros tumores (fuera del SNC) (Cohorte 5)
    •Recidivados o resistentes al tratamiento de referencia sin otras opciones terapéuticas disponibles
    •Asociados a una mutación del gen IDH1 confirmada histológica o citológicamente con enfermedad mensurable según los criterios de respuesta para la enfermedad pertinente
    5.Recuperación a grado ≤2 o a la toxicidad inicial (excepto la alopecia) del tratamiento previo (según los CTCAE v 4.03)
    6.Estado funcional según la escala del ECOG (Grupo Oncológico Cooperativo del Este) de 0 a 2.
    7.Función suficiente de la médula ósea
    •Recuento absoluto de neutrófilos (RAN) ≥1,5 × 109/l sin ningún factor de crecimiento en los 7 días anteriores
    •Hemoglobina ≥8,0 g/dl (con o sin apoyo transfusional)
    Número de plaquetas ≥75 × 109/l (con o sin apoyo transfusional); Cohorte 4b (combinación de GemCis): número de plaquetas ≥100 × 109/l (con o sin apoyo transfusional)
    8.Función hepática suficiente
    •Aspartato-aminotransferasa (AST) (transaminasa glutámico-oxalacética sérica)/alanina-aminotransferasa (ALT) (transaminasa glutámico-pirúvica sérica) ≤2,5 veces el límite superior de la normalidad (LSN) del centro. En pacientes con sospecha de elevaciones relacionadas con la neoplasia maligna, <5 veces el LSN
    •Bilirrubina total ≥1,5 veces el LSN En pacientes con sospecha de una elevación relacionada con la neoplasia maligna, <3 veces el LSN del centro
    9.Función renal suficiente:
    •Aclaramiento de creatinina según la ecuación de Cockcroft-Gault de ≥60 ml/min
    10.En las mujeres con posibilidad de quedar embarazadas: resultado negativo en la prueba de embarazo en suero de la subunidad β de la gonadotropina coriónica humana (β-hCG) en la semana anterior al primer tratamiento (las mujeres con posibilidad de quedar embarazadas son las mujeres sexualmente maduras que no se han sometido a esterilización quirúrgica o que no llevan siendo posmenopáusicas de forma natural durante al menos 12 meses consecutivos en caso de que tengan >55 años)
    11.Disposición de pacientes de ambos sexos que no sean quirúrgicamente estériles y de las mujeres posmenopáusicas a usar métodos anticonceptivos médicamente aceptables mientras dure el tratamiento del estudio, incluidos los 90 días siguientes a la última dosis del fármaco del estudio. Los varones sexualmente activos y las mujeres que utilicen anticonceptivos orales también deben utilizar métodos anticonceptivos de barrera. Los varones deben aceptar no donar esperma mientras participen en el estudio y durante los 90 días posteriores a la última dosis del fármaco del estudio.
    12.Capacidad para cumplir el calendario de visitas del estudio y todos los requisitos del protocolo
    13.Haber firmado y fechado el formulario de consentimiento informado aprobado por el CEIm antes de que se realice cualquier procedimiento de selección.
    E.4Principal exclusion criteria
    Patients are to be excluded from the study if they meet any of the following criteria:
    1. Previous solid organ or hematopoietic cell transplant
    2. Less than the minimum time has elapsed from prior anticancer treatment to first dose of study treatment as follows:
    • Small molecule, antibody, or other anticancer therapeutic: 21 days (or 5 half-lives), whichever is shorter. Nitrosoureas or mitomycin C: 6 weeks. For patients enrolling in the Phase 2 (beyond Safety Lead-in with IHCC): 14 days from GemCis therapy.
    • Prior radiation therapy (including radiofrequency ablation): 4 weeks
    • Prior stereotactic body radiation therapy: 2 weeks
    • Prior chemoembolization or radioembolization: 4 weeks
    3. No previous treatment with an IDH1 inhibitor (single agent FT-2102 cohorts only)
    4. Congestive heart failure (New York Heart Association Class III or IV) or unstable angina pectoris; previous history of myocardial infarction within one year prior to study entry, uncontrolled hypertension, or uncontrolled arrhythmias
    5. History of QT prolongation or baseline QT interval corrected with Fridericia’s method (QTcF) >450 ms (average of triplicate readings)
    NOTE: criterion does not apply to patients with a right or left bundle branch block, a cardiology consult is recommended to assure that QTcF is not prolonged.
    6. Concomitant medication(s) associated with QTc interval prolongation or Torsades de Pointes (TdP) initiated less than the duration required to reach steady-state plasma concentration (approximately five half-lives) before first dose of study drug (see Appendix 3) (medications used as needed [PRN] (e.g., Zofran) are exempt).
    7. Pregnant or nursing women or WCBP not using adequate contraception; male patients not using adequate contraception
    8. Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ, stage 1, grade 1 endometrial carcinoma, or other solid tumors including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for ≥5 years
    9. Major surgery within 4 weeks of starting study treatment or not recovered from any effects of prior major surgery (uncomplicated central line placement or fine needle aspirate are not considered major surgery)
    10. Receipt of a live vaccine (including yellow fever vaccine) within 30 days of first day of study treatment
    11. Patients receiving >6 mg/day of dexamethasone or equivalent
    12. Patients with gastrointestinal disorders likely to interfere with absorption of the study medication
    13. Known human immunodeficiency virus positivity (HIV)
    14. Active infection with hepatitis B or C virus (Hep B or C viral load>100 international units/milliliter or local institutional equivalent)
    15. Unstable or severe uncontrolled medical condition (e.g., unstable cardiac function, unstable pulmonary condition including pneumonitis and/or interstitial lung disease, uncontrolled diabetes) or any important medical or psychiatric illness or abnormal laboratory finding that would, in the Investigator’s judgment, increase the risk to the patient associated with his or her participation in the study. This includes any condition that would be considered a contraindication per local prescribing information to receipt of either azacitidine, nivolumab, gemcitabine or cisplatin based on cohort assigned (combination patients only).
    16. PD-1 combination only:
    a. Patients with active autoimmune disease
    Note: patients with well controlled diabetes or hypothyroidism are eligible
    Los pacientes deben ser excluidos del estudio si cumplen alguno de los siguientes criterios:
    1.Trasplante de órgano macizo o de células hematopoyéticas con anterioridad
    2.Ha transcurrido menos del tiempo mínimo establecido desde el tratamiento anterior contra el cáncer hasta la primera dosis del tratamiento del estudio, siendo el tiempo mínimo el siguiente:
    •Micromoléculas, anticuerpos u otros tratamientos contra el cáncer: 21 días (o 5 semividas), lo que sea más corto. Nitrosoureas o mitomicina C: 6 semanas. Para los pacientes a los que se incluya en la fase 2 (después de la preinclusión de seguridad con CCIH): 14 días desde el tratamiento con GemCis.
    •Radioterapia previa (incluida ablación con radiofrecuencia): 4 semanas
    •Radioterapia estereotáctica previa: 2 semanas
    •Quimioembolización o radioembolización previa: 4 semanas
    3.No haber recibido tratamiento previo con un inhibidor de la IDH1 (solo las cohortes de tratamiento con FT-2102 en monoterapia)
    4.Insuficiencia cardíaca congestiva (clases III o IV de la New York Heart Association) o angina de pecho inestable; antecedentes de infarto de miocardio en el año anterior a la entrada en el estudio, hipertensión no controlada o arritmias no controladas
    5.Antecedentes de prolongación del intervalo QT o intervalo QT inicial corregido con el método de Fridericia (QTcF) >450 ms (promedio de tres lecturas)
    Nota: El criterio no se aplica a los pacientes con bloqueo de rama derecha o izquierda, se recomienda consultar con cardiología para asegurarse de que no haya prolongación del intervalo QTcF.
    6.Medicamentos concomitantes asociados a la prolongación del intervalo QTc o a taquicardias ventriculares helicoidales (torsades de pointes, TdP) recibidos durante un período de tiempo menor del requerido para alcanzar la concentración plasmática en estado de equilibrio (aproximadamente cinco semividas) antes de la primera dosis del fármaco del estudio (véase el Anexo 3 de la v2 del protocolo) (los medicamentos utilizados según necesidad [SN] [p. ej., Zofran] están exentos).
    7.Mujeres embarazadas o en período de lactancia o mujeres con posibilidad de quedar embarazadas que no utilizan métodos anticonceptivos adecuados; pacientes varones que no utilizan métodos anticonceptivos adecuados
    8.Otros tumores malignos en los últimos 5 años excepto: cáncer de piel no melanomatoso tratado adecuadamente, cáncer in situ del cuello uterino con tratamiento curativo, carcinoma ductal in situ (CDIS) en estadio 1 y carcinoma endometrial de grado 1 u otros tumores sólidos, entre ellos linfomas (sin afectación de la médula ósea) con tratamiento curativo y sin signos de enfermedad durante ≥5 años.
    9.Cirugía mayor en las 4 semanas previas al inicio del tratamiento del estudio o pacientes que no se hayan recuperado de cualquier efecto de una cirugía mayor anterior (la colocación de una vía central sin complicaciones o la biopsia con aguja fina no se consideran cirugía mayor)
    10.Administración de una vacuna elaborada con virus vivos (incluida la vacuna antiamarílica) en los 30 días previos al primer día del tratamiento del estudio
    11.Pacientes que reciben >6 mg/día de dexametasona o equivalente
    12.Pacientes con trastornos gastrointestinales que puedan interferir en la absorción del medicamento del estudio
    13.Positividad conocida del virus de la inmunodeficiencia humana (VIH)
    14.Infección activa por el virus de la hepatitis B o C (concentración vírica de hepatitis B o C >100 unidades internacionales/mililitro o equivalente local del centro)
    15.Proceso patológico inestable o grave no controlado (p. ej., función cardíaca inestable, enfermedad pulmonar inestable incluida neumonitis o enfermedad pulmonar intersticial, diabetes no controlada) o cualquier enfermedad médica o psiquiátrica importante o resultado analítico anómalo que, según el criterio del investigador, aumenta el riesgo para el paciente asociado a su participación en el estudio. Esto incluye cualquier trastorno que se consideraría una contraindicación según la ficha técnica local al tratamiento con azacitidina, nivolumab, gemcitabina o cisplatino, dependiendo de la cohorte asignada (solo los pacientes con tratamiento combinado).
    16.Solo en combinación con PD-1:
    •Pacientes con enfermedad autoinmunitaria activa
    Nota: Los pacientes con diabetes bien controlada o hipotiroidismo son elegibles
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1b:
    • DLTs (Safety Lead-in Periods), AEs, and safety laboratory values
    Phase 2:
    • Objective response rate (ORR) as determined by applicable disease criteria, for disease-specific cohorts
    FAse 1b:
    •TLD (períodos de preinclusión de seguridad), AA y valores analíticos de seguridad
    Fase 2:
    •Tasa de respuesta objetiva (TRO) determinada por los criterios de la enfermedad aplicables, para las cohortes de enfermedades específicas
    E.5.1.1Timepoint(s) of evaluation of this end point
    DLTs will be evaluated during the Safety Lead-in Period during the first treatment cycle, patients will be monitored continuously for toxicity while on study drug and or all parts of the study, response and progression will be determined by Investigator assessment using the appropriate response criteria per disease at the time points shown in Table 8 of the protocol.
    Los TLDs serán evaluados durante el periodo de preinclusión de seguridad en el primer ciclo de tratamiento, los pacientes serán monitorizados de manera contínua en caso de toxicidad mientras estén tomando el fármaco del estudio y la respuesta y la progresión serán evaluadas por el investigador usando los criterios de respuesta apropiados según la patología y el momento que se muestra en la tabla 8 del protocolo.
    E.5.2Secondary end point(s)
    • AEs, and safety laboratory values (Phase 2)
    • ORR (Phase 1b only)
    • Progression-free survival (PFS), defined as the time from the first dose to disease progression as determined by applicable disease criteria or death due to any cause, whichever is sooner
    • Time to progression (TTP), defined as the time from start of treatment until disease specified progression.
    • Duration of response (DOR), defined as the time from the first response to documented disease progression as determined by applicable disease criteria
    • Overall Survival (OS), defined as the time from the first dose to death due to any cause
    • Time to Response (TTR), defined as the time from first dose to first response
    • AEs and abnormal laboratory findings
    • PK parameters derived from plasma/CSF FT-2102 concentrations
    •AA y valores analíticos de seguridad (fase 2)
    •TRO (solo en la fase 1b)
    •Supervivencia sin progresión (SSP), definida como el tiempo transcurrido desde la primera dosis hasta la progresión de la enfermedad según lo determinado por los criterios de la enfermedad aplicables o la muerte por cualquier causa, lo que ocurra antes
    •Tiempo transcurrido hasta la progresión (THP), definido como el tiempo transcurrido desde el inicio del tratamiento hasta la progresión de la enfermedad específica
    •Duración de la respuesta (DDR), definida como el tiempo transcurrido desde la primera respuesta hasta la progresión documentada de la enfermedad según lo determinado por los criterios de la enfermedad aplicables.
    •Supervivencia global (SG), definida como el tiempo transcurrido desde la primera dosis hasta la muerte por cualquier causa
    •Tiempo que tarda en alcanzarse la respuesta terapéutica (TTR), definido como el tiempo transcurrido desde la primera dosis hasta la primera respuesta
    •AA y resultados analíticos anómalos
    •Parámetros FC derivados de concentraciones de FT-2102 en plasma/LCR
    E.5.2.1Timepoint(s) of evaluation of this end point
    Patients will be monitored continuously for toxicity while on study drug and or all parts of the study, response and progression will be determined by Investigator assessment using the appropriate response criteria per disease at the time points shown in Table 8 of the protocol.
    Los pacientes serán monitorizados de manera contínua en caso de toxicidad mientras estén tomando el fármaco del estudio y la respuesta y la progresión serán evaluadas por el investigador usando los criterios de respuesta apropiados según la patología y el momento que se muestra en la tabla 8 del protocolo.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase 1b Safety Lead-in Period
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Basket study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 EEA14
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    France
    Korea, Republic of
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months30
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial months30
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state19
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    F.4.2.2In the whole clinical trial 200
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Not applicable.
    No aplica.
    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 Decision2019-03-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-06-13
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