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    Summary
    EudraCT Number:2018-003896-37
    Sponsor's Protocol Code Number:ODO-TE-B201
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-04-12
    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 number2018-003896-37
    A.3Full title of the trial
    A Multinational, Multicenter, Phase 2 Study of Tesetaxel plus a Reduced Dose of Capecitabine in Patients with HER2 Negative, Hormone Receptor Positive, Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Received a Taxane
    Un estudio multinacional, multicéntrico, fase 2 de tesetaxel más una dosis reducida de capecitabina en pacientes con HER2 negativo, receptor hormonal positivo, cáncer de mama localmente avanzado o metastásico que no han recibido previamente el tratamiento con taxane
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    n/a
    A.4.1Sponsor's protocol code numberODO-TE-B201
    A.5.4Other Identifiers
    Name:US INDNumber:062584
    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 SponsorOdonate 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 supportOdonate Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOdonate Therapeutics, Inc.
    B.5.2Functional name of contact pointChief Development Officer
    B.5.3 Address:
    B.5.3.1Street Address4747 Executive Drive, Suite 590
    B.5.3.2Town/ citySan Diego
    B.5.3.3Post code92121
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1858731 8180
    B.5.5Fax number+1858200 3837
    B.5.6E-mailregulatory@odonate.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 nametesetaxel
    D.3.2Product code DJ-927
    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 INNTesetaxel
    D.3.9.1CAS number 333754-36-2
    D.3.9.2Current sponsor codeDJ-927, C13022716-S2
    D.3.9.3Other descriptive nameUNII-UG97LO5M8Y
    D.3.9.4EV Substance CodeSUB36078
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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: 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 nametesetaxel
    D.3.2Product code DJ-927
    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 INNTesetaxel
    D.3.9.1CAS number 333754-36-2
    D.3.9.2Current sponsor codeDJ-927, C13022716-S2
    D.3.9.3Other descriptive nameUNII-UG97LO5M8Y
    D.3.9.4EV Substance CodeSUB36078
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 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 Xeloda
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration 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 nameXeloda
    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.3.9.1CAS number 154361-50-9
    D.3.9.2Current sponsor codeXeloda
    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: 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 Xeloda
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration 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 nameXeloda
    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.3.9.1CAS number 154361-50-9
    D.3.9.2Current sponsor codeXeloda
    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.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
    cáncer de mama
    E.1.1.1Medical condition in easily understood language
    breast cancer
    cáncer de mama
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10057654
    E.1.2Term Breast cancer female
    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 10061020
    E.1.2Term Breast cancer male
    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 10006201
    E.1.2Term Breast cancer stage III
    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 10006202
    E.1.2Term Breast cancer stage IV
    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 10006187
    E.1.2Term Breast 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 20.1
    E.1.2Level PT
    E.1.2Classification code 10055113
    E.1.2Term Breast cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To establish the efficacy of tesetaxel plus a reduced dose of capecitabine in patients with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive, locally advanced or metastatic breast cancer (LA/MBC) not previously treated with a taxane in the neoadjuvant, adjuvant, or metastatic setting
    Establecer la eficacia de tesetaxel con una dosis reducida de capecitabina en pacientes con cáncer de mama localmente avanzado o metastásico (CMLA/M), con receptor hormonal positivo (RH) y sin receptor del factor de crecimiento epidérmico humano 2 (HER2 negativo) que no hayan recibido ningún taxano anteriormente en el contexto neoadyuvante, adyuvante o metastásico.
    E.2.2Secondary objectives of the trial
    SECONDARY OBJECTIVE
    - To assess the safety and tolerability of tesetaxel plus a reduced dose of capecitabine in patients with HER2 negative, HR positive LA/MBC not previously treated with a taxane in the neoadjuvant, adjuvant, or metastatic setting

    PHARMACOKINETIC OBJECTIVES
    - To investigate the relationship between the pharmacokinetics (PK) of tesetaxel and efficacy and safety endpoints in patients with HER2 negative, HR positive LA/MBC not previously treated with a taxane in the neoadjuvant, adjuvant, or metastatic setting
    - To investigate the potential for a PK drug-drug interaction of tesetaxel on capecitabine and its active metabolite, fluorouracil (5-FU)
    OBJETIVO SECUNDARIO
    -Evaluar la seguridad y tolerabilidad de tesetaxel con una dosis reducida de capecitabina en pacientes con CMLA/M con RH y sin HER2 que no hayan recibido ningún taxano anteriormente en el contexto neoadyuvante, adyuvante o metastásico.

    OBJETIVO FARMACOCINÉTICA
    -Investigar la relación entre la farmacocinética (FC) de tesetaxel y los criterios de valoración de la eficacia y la seguridad en pacientes con CMLA/M con RH y sin HER2 que no hayan recibido ningún taxano anteriormente en el contexto neoadyuvante, adyuvante o metastásico.
    -Investigar el potencial de interacción farmacológica FC de tesetaxel sobre la capecitabina y su metabolito activo, fluorouracilo (5-FU).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All of the following criteria must be met:

    1. Female or male patients at least 18 years of age
    2. Histologically or cytologically confirmed breast cancer
    3. HER2 negative disease based on local testing: American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines should be utilized for assessing HER2 status
    4. HR (estrogen receptor [ER] and/or progesterone receptor [PgR]) positive disease based on local testing: ASCO/CAP guidelines should be utilized for assessing HR status
    5. Measurable disease per RECIST 1.1, including bone-only disease with measurable lytic component
    - Patients with bone-only metastatic cancer must have a measurable lytic or mixed lytic-blastic lesion that can be accurately assessed by computerized tomography (CT) or magnetic resonance imaging (MRI). Patients with bone-only disease without a measurable lytic component (ie, blastic-only metastasis) are not eligible.
    - Known metastases to the CNS are permitted but not required. The following criteria apply:
    - Patients must be neurologically stable and either off corticosteroids or currently treated with a maximum daily dose of 4 mg of dexamethasone (or equivalent), with no increase in corticosteroid dose within 7 days prior to Enrollment (defined as the time of Sponsor approval of treatment dose)
    - Patients with a history of CNS metastases but with no current evidence of CNS lesions following local therapy are eligible
    - Patients may have CNS metastases that are stable or progressing radiologically
    - Patients with current evidence of leptomeningeal disease are not eligible
    - Patients may have untreated brain metastases or previously treated brain metastases, as long as no immediate local CNS-directed therapy is indicated
    - Any prior whole brain radiation therapy must have been completed > 14 days prior to the date of Enrollment
    - Prior stereotactic brain radiosurgery is permitted
    - CNS surgical resection must have been completed > 28 days prior to the date of Enrollment; patient must have complete recovery from surgery
    6. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
    7. Prior endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor unless endocrine therapy is not indicated (ie, short relapse-free interval while on adjuvant endocrine therapy [endocrine resistance]; rapidly progressing disease/visceral crisis; or endocrine intolerance). Any targeted therapies approved for HER2 negative, HR positive LA/MBC, including everolimus, are permitted as prior therapy. There is no limit to the number of prior endocrine therapies.
    8. Documented (including de novo): (a) locally advanced breast cancer that is not considered curable by surgery and/or radiation; or (b) metastatic breast cancer
    9. Adequate hematologic, hepatic, and renal function, as evidenced by:
    - Absolute neutrophil count (ANC) ≥ 1,500/μL without colony-stimulating factor support
    - Platelet count ≥ 100,000/μL
    - Hemoglobin ≥ 10 g/dL without need for hematopoietic growth factor or transfusion support
    - Total bilirubin < 1.5 × upper limit of normal (ULN); does not apply to patients with Gilbert’s syndrome
    - Alanine aminotransferase (ALT) < 3 × ULN unless hepatic metastases are present, then < 5 × ULN
    - Aspartate aminotransferase (AST) < 3 × ULN unless hepatic metastases are present, then < 5 × ULN
    - Alkaline phosphatase < 2.5 × ULN unless hepatic metastases are present, then < 5 × ULN
    - Calculated creatinine clearance ≥ 50 mL/min (by Cockcroft-Gault formula or local standard)
    - Serum albumin ≥ 3.0 g/dL
    - Prothrombin time (PT) < 1.5 × ULN or international normalized ratio (INR) < 1.3 and partial thromboplastin time (PTT) < 1.5 × ULN, unless the patient is on a therapeutic anticoagulant
    10. Complete recovery to baseline or Grade 1 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 from adverse effects of prior surgery, radiotherapy, endocrine therapy, and other therapy, as applicable, with the exception of Grade 2 alopecia from prior chemotherapy
    11. Ability to swallow an oral solid-dosage form of medication
    12. A negative serum pregnancy test within 7 days prior to the first dose of Study treatment in women of childbearing potential (ie, all women except those who are post menopause for ≥ 1 year or who have a history of hysterectomy or surgical sterilization)
    13. Women of childbearing potential must use an effective, non-hormonal form of contraception from Screening throughout the Treatment Phase and until 70 days after the last dose of Study treatment
    - Acceptable methods include: copper intrauterine device or double barrier methods, including male/female condoms with spermicide and use of contraceptive sponge, cervical cap, or diaphragm

    Please refer to the Study Protocol for further inclusion criteria.
    Todos los criterios de inclusión deben de cumplirse:
    1. Pacientes masculino o femenino de al menos 18 años.
    2. Cáncer de mama confirmado mediante evaluación histológica o una citología.
    3. Enfermedad HER2 negativa según el análisis local: para la evaluación del estado de HER2 se deben emplear las directrices de la Sociedad americana de oncología clínica/Colegio americano de patólogos
    4. Enfermedad RH positiva (receptor de estrógeno [RE] y receptor de progesterona [RPg]) según el análisis local: para la evaluación del estado de RH se deben emplear las directrices de la ASCO/CAP.
    5. Enfermedad medible según RECIST 1.1, incluidos los pacientes con enfermedad solo ósea con un componente lítico medible.
    -Los pacientes con cáncer metastásico solo óseo deben tener una lesión lítica o blástica lítica mixta medible que pueda evaluarse con exactitud mediante TAC o RMN. Los pacientes con enfermedad solo ósea sin un componente lítico medible (es decir, metástasis solo blásticas) no son aptos.
    -Se permiten las metástasis conocidas en el SNC, aunque no es necesario. Se aplican los siguientes criterios:
    -Los pacientes deben permanecer estables neurológicamente y no recibir tratamiento con corticoesteroides, o bien, recibir en la actualidad una dosis diaria máxima de 4 mg de dexametasona (o un equivalente), sin que se haya aumentado la dosis de corticoesteroides en los 7 días previos a la inscripción (que se define como el momento de la aprobación de la dosis del tratamiento por parte del promotor).
    -Son aptos los pacientes con antecedentes de metástasis en el SNC, pero para los que no existe en la actualidad evidencia de lesiones del SNC tras haber recibido tratamiento local.
    -Pueden tener metástasis en el SNC estables o con progresión radiológica.
    -Los pacientes con evidencia actual de enfermedad leptomeníngea no son aptos.
    -Pueden tener metástasis cerebrales no tratadas o metástasis cerebrales previamente tratadas, siempre que no esté indicado un tratamiento local inmediato dirigido al SNC.
    -Radioterapia del cerebro completo se debe haber completado >14 días antes de la fecha de inscripción.
    -Se permite la radiocirugía estereotáctica del cerebro.
    -La resección quirúrgica del SNC se debe haber completado >28 días antes de la fecha de inscripción; los pacientes se deben haber recuperado por completo de la cirugía.
    6. Estado funcional de 0, 1 o 2 conforme al Grupo oncológico cooperativo del este (Eastern Cooperative Oncology Group, ECOG).
    7. Tratamiento endocrino previo con o sin un inhibidor de las cinasas dependientes de las ciclinas (CDK) 4 y 6, excepto cuando el tratamiento endocrino no esté indicado (es decir, un intervalo breve sin recidivas mientras recibe tratamiento endocrino adyuvante [resistencia endocrina], enfermedad/crisis visceral de progresión rápida o intolerancia endocrina). Se permite como tratamiento previo todo tratamiento dirigido y aprobado para el CMLA/M con RH y sin HER2, incluido everolimus. No existe un límite del número de tratamientos endocrinos previos.
    8. La siguiente enfermedad documentada (incluida de novo): (a) cáncer de mama localmente avanzado que no se considera curable mediante cirugía o radiación; o (b) cáncer de mama metastásico.
    9. Función hematológica, hepática y renal adecuada, según:
    -Recuento absoluto de neutrófilo (RAN) ≥1500/μl sin tratamiento de apoyo mediante un factor de estimulación de colonias
    -Recuento de plaquetas ≥100000/μl
    -Hemoglobina ≥10 g/dl sin necesidad de tratamiento de apoyo con factor de crecimiento hematopoyético o transfusiones
    -Bilirrubina total <1,5 × LSN; esto no es aplicable a pacientes con el síndrome de Gilbert
    -Alanina aminotransferasa (ALT) <3 × LSN, excepto si existen metástasis hepáticas; en ese caso el valor de la ALT será de <5 × LSN
    -Aspartato aminotransferasa (AST) <3 × LSN, excepto si existen metástasis hepáticas; en ese caso el valor de la AST será de <5 × LSN
    -Fosfatasa alcalina <2,5 × LSN, excepto si existen metástasis hepáticas; en ese caso el valor será de <5 × LSN
    -Aclaramiento de creatinina calculado ≥50 ml/min (utilizando la fórmula de Cockcroft-Gault o los procedimientos locales habituales)
    -Albúmina sérica ≥3,0 g/dl
    -Tiempo de protrombina (TP) <1,5 × LSN o índice internacional normalizado (INR) <1,3 y tiempo de tromboplastina parcial (TTP) <1,5 × LSN, excepto si el paciente está recibiendo un anticoagulante terapéutico
    10. Recuperación completa al estado inicial o grado 1 según la versión 5.0 de los Criterios de terminología común para acontecimientos adversos (CTCAE) del Instituto Nacional del Cáncer de los acontecimientos adversos de una cirugía, radioterapia, tratamiento endocrino y cualquier otro tratamiento anteriores, según corresponda, a excepción de la alopecia de grado 2 relacionada con una quimioterapia anterior.
    11. Capacidad de ingerir una forma farmacéutica sólida oral del medicamento.

    Consulte el protocolo de estudio para obtener más información sobre los criterios de inclusión..

    E.4Principal exclusion criteria
    1. Two or more prior chemotherapy regimens for advanced disease
    2. Prior treatment with a taxane at any dose
    3. Prior treatment with capecitabine at any dose
    4. Current evidence of leptomeningeal disease
    5. Other cancer that required therapy within the preceding 5 years other than adequately treated: (a) non melanoma skin cancer or in situ cancer; or (b) following approval by the Medical Monitor, other cancer that has a very low risk of interfering with the safety or efficacy endpoints of the Study
    6. Known human immunodeficiency virus infection, unless well controlled. Patients who are on an adequate antiviral regimen with no evidence of active infection are considered well controlled.
    7. Active hepatitis B or active hepatitis C infection
    8. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with Study participation or investigational product administration or may interfere with the interpretation of Study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this Study
    9. Presence of neuropathy > Grade 1 per NCI CTCAE version 5.0
    10. Anticancer treatment, including endocrine therapy, radiotherapy (except stereotactic brain radiosurgery), chemotherapy, biologic therapy, or therapy in an investigational clinical study, ≤ 14 days prior to the date of Enrollment
    11. Major surgery ≤ 28 days prior to the date of Enrollment; patient must have complete recovery from surgery
    12. Less than 2 weeks or 5 plasma half-lives (whichever is greater) since last use of a medication or ingestion of an agent, beverage, or food that is a known clinically relevant strong inhibitor or known clinically relevant inducer of the cytochrome P450 (CYP)3A pathway (patients should discontinue taking any regularly-taken medication that is a strong inhibitor or inducer of the CYP3A pathway)
    13. History of hypersensitivity or unexpected reactions to capecitabine, fluoropyrimidine agents or any of their ingredients
    14. Known dihydropyrimidine dehydrogenase (DPD) deficiency. Testing for DPD deficiency must be performed where required by local regulations, using a validated method that is approved by local health authorities.
    15. Pregnant or breastfeeding
    16. If, in the opinion of the Investigator, the patient is deemed unwilling or unable to comply with the requirements of the Study
    17. Treatment with brivudine, sorivudine, or its chemically-related analogs ≤ 28 days prior to the date of Enrollment
    1. Dos o más regímenes de quimioterapia previos para la enfermedad avanzada.
    2. Tratamiento previo con taxano a cualquier dosis.
    3. Tratamiento previo con capecitabina a cualquier dosis.
    4. Evidencia actual de enfermedad leptomeníngea.
    5. Otro cáncer en los 5 años anteriores que requirió tratamiento, salvo los siguientes tipos de cáncer tratados adecuadamente: (a) cáncer de piel distinto del melanoma o cáncer in situ, o (b) tras la aprobación del monitor médico, otro tipo de cáncer con un riesgo muy bajo de interferir en los criterios de valoración de la seguridad y la eficacia del estudio.
    6. Infección conocida por el virus de la inmunodeficiencia humana, excepto si está bien controlada. Se considera que están bien controlados aquellos pacientes que reciben un régimen antiviral adecuado sin evidencia de infección activa.
    7. Infección activa por hepatitis B o C.
    8. Otra anomalía de laboratorio o afección psiquiátrica o médica grave, crónica o aguda, que pueda aumentar el riesgo asociado con la participación en el estudio o la administración del producto en investigación, o que pueda interferir en la interpretación de los resultados del estudio y que, en la opinión del investigador, haga que el paciente no sea adecuado para entrar en este estudio.
    9. Presencia de neuropatía > grado 1, según la versión 5.0 de los CTCAE del NCI
    10. Tratamiento antineoplásico, incluidos tratamiento endocrino, radioterapia (excepto radiocirugía estereotáctica del cerebro), quimioterapia, tratamiento biológico o tratamiento en un estudio clínico de investigación ≤14 días antes de la fecha de inscripción.
    11. Cirugía mayor ≤28 días antes de la fecha de inscripción; el paciente se debe haber recuperado por completo de la cirugía.
    12. Menos de 2 semana o 5 semividas plasmáticas (lo que sea mayor) desde el último uso de un medicamento o de haber ingerido un agente, bebida o alimento que sea un inhibidor potente conocido de relevancia clínica o un inductor conocido de la vía del citocromo P450 (CYP)3A de relevancia clínica (los pacientes deben suspender la administración de cualquier medicamento que tomen de forma regular que sea un inhibidor o inductor potente de la vía del CYP3A).
    13. Antecedentes de hipersensibilidad o reacciones imprevistas a capecitabina, fluoropirimidinas o a cualquiera de sus componentes.
    14. Deficiencia conocida de dihidropiridina deshidrogenasa (DPD). Se debe realizar el análisis para la determinación de una deficiencia de DPD cuando las normativas locales lo exijan, utilizando para ello un método validado y aprobado por las autoridades sanitarias locales.
    15. Embarazo o lactancia
    16. Si, en la opinión del investigador, se considera que el paciente no está dispuesto o no puede cumplir con los requisitos del estudio.
    17. Tratamiento con brivudina, sorivudina o sus análogos químicamente relacionados ≤28 días antes de la fecha de inscripción.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is objective response rate (ORR) as assessed by an Independent Radiologic Review Committee (IRC).

    The ORR is defined as the proportion of patients who achieve a best overall response of complete response (CR) or partial response (PR) per RECIST 1.1. The ORR with the exact binomial 95% confidence interval (CI) will be reported. The primary efficacy analysis will require confirmation of response on subsequent assessment at least 4 weeks after the initial assessment and will be based on tumor assessments by the IRC.
    El criterio de valoración principal es establecer la tasa de respuesta objetiva (TRO) según la evaluación de un comité de revisión radiológica independiente (CRI)

    La TRO se define como la proporción de pacientes que alcanzan una mejor respuesta global de respuesta completa (RC) o respuesta parcial (RP), según RECIST 1.1. Se notificará la TRO con el IC binomial exacto del 95 %. Los análisis principales de la eficacia requerirán la confirmación de la respuesta mediante una evaluación posterior al menos 4 semanas después de la evaluación inicial y se basarán en las evaluaciones tumorales del CRI.
    E.5.1.1Timepoint(s) of evaluation of this end point
    No interim analyses for purposes of early stoppage of the Study are planned.

    The projected timing for evaluation of the primary endpoint is approximately 2 - 2.5 years following Study initiation.
    No se han previsto análisis intermedios para la interrupción anticipada del Estudio.

    El tiempo proyectado para la evaluación del criterio de valoración primario es aproximadamente de 2 a 2,5 años después del inicio del estudio.
    E.5.2Secondary end point(s)
    SECONDARY EFFICACY ENDPOINTS (in order of importance):

    ● Duration of response (DoR) as assessed by the IRC
    - DoR = time from date of first tumor assessment with documented response (CR or PR) according to RECIST 1.1 to date of disease progression or death using the same rules and censuring rules applied to PFS
    - Kaplan-Meier statistics will follow those presented for PFS

    ● Progression-free survival (PFS) as assessed by the IRC
    - PFS = time from Treatment Initiation to first observed PD or death by any cause
    - PFS of patients with death or PD after two or more missed radiologic disease assessment visits will be censored at the last evaluable PFS assessment by the IRC
    - Distributions of PFS times will be estimated using the Kaplan Meier product-limit method. The median PFS along with the associated 2 sided 95% CI will be estimated. A Cox proportional hazards model will be used to estimate the hazard ratio and 95% CI between subgroups

    ● Disease control rate (DCR) as assessed by the IRC
    - DCR = proportion of patients in that group who achieve an objective response or maintain stable disease for at least 24 weeks
    - Similar analyses as described for ORR will be conducted for this endpoint

    ● Overall survival (OS)
    - OS = time from date of Cycle 1 Day 1 to death due to any cause
    - Patients will be followed for survival for up to 24 months from the date of Cycle 1, Day 1, unless occurrence of death, lost to follow-up, or Study closure
    - The analysis of OS will be performed as described for PFS. In addition, the OS at one-year and two-year will be estimated along with 95% CI

    CNS METASTASES EFFICACY ENDPOINTS:

    ● CNS ORR as assessed by the CNS IRC in patients with CNS metastases at baseline
    - CNS ORR = proportion of patients with CNS metastases at baseline who achieve a best overall response of CR or PR based on CNS lesions

    ● CNS DoR as assessed by the CNS IRC in patients with CNS metastases at baseline
    - CNS DoR = time from date of first CNS tumor burden assessment with a documented response (CR or PR) to date of CNS disease progression or death in patients with CNS metastases at baseline
    - The same rules and censuring rules applied to CNS PFS will be used for CNS DoR
    - Kaplan-Meier statistics will follow those presented for CNS PFS

    ● CNS PFS as assessed by the CNS IRC in patients with CNS metastases at baseline or a history of CNS metastases and in the intent-to-treat (ITT) population
    - CNS PFS will be analyzed using the Kaplan-Meier product-limit method as per primary PFS analysis in patients with CNS metastases at baseline or a history of CNS metastases and in the ITT population based on CNS disease sites and all disease sites
    - If no brain scans were conducted at baseline and later time points, patients will be assumed to be free of CNS disease at those respective time points

    ● CNS OS in patients with CNS metastases at baseline or a history of CNS metastases
    - CNS OS will be analyzed using the Kaplan-Meier product-limit method as per the primary PFS analysis in patients with CNS metastases at baseline or a history of CNS metastases

    SAFETY ENDPOINTS:

    ● Adverse events (AEs), including deaths and other serious adverse events (SAEs)
    - Treatment-emergent adverse events (TEAEs) are those AEs that occur or worsen on or after first administration of any Study treatment through 30 days after the last administration of any Study treatment. TEAEs will be graded according to NCI CTCAE version 5.0, grouped by Medical Dictionary for Regulatory Activities (MedDRA) preferred term, and summarized by worst grade severity per patient
    - SAEs will be summarized. TEAEs leading to discontinuation of Study treatment or any other premature interruption will be tabulated and summarized. Deaths due to AE and deaths due to any reason other than disease progression will be tabulated and summarized. (Deaths due to disease progression will not be captured as AEs/SAEs)

    ● Clinical laboratory abnormalities
    - Clinically significant laboratory abnormalities (eg, those that result in treatment modification and/or require intervention) will be recorded as AEs Where appropriate, AEs will be pooled across MedDRA terms (eg, neutropenia and reduced ANC)

    PHARMACOKINETIC ENDPOINTS:

    ● Tesetaxel PK and its association with efficacy and safety endpoints
    - Determinants of PK variability will be studied using a non-linear, mixed-effects modeling analysis of both dense and sparse PK data, including estimation of inter-individual PK variability and PK parameters with covariate analysis

    ● The effect of tesetaxel on capecitabine and 5-FU Cmax and AUC
    - PK of tesetaxel will be assessed by comparing the least squares mean ratio and 90% CI of log-transformed Cmax and AUC0-t for patients at the capecitabine twice a day dose level of 825 mg/m2. Magnitude of effect will be compared to PK following a single dose of capecitabine at either 825 mg/m2 or 1,250 mg/m2
    Criterios de eficacia secundarios
    ● Duración de la respuesta (DR) conforme a la evaluación del CRI
    DR=se define como el tiempo desde la fecha de la primera evaluación del tumor con una respuesta documentada (RC o RP), según RECIST 1.1, hasta la fecha de progresión de la enfermedad o la muerte, utilizando para ello las mismas normas y normas de censura aplicadas a la SSP. Las estadísticas de Kaplan-Meier seguirán aquellas indicadas para la SSP.
    ● SSP conforme a la evaluación del CRI
    SSP se define como el tiempo desde el día 1 del ciclo 1 hasta la PE observada por primera vez o la muerte por cualquier causa.
    La SSP de los pacientes con muerte o PE tras la omisión de dos o más evaluaciones radiológicas de la enfermedad se censurará en el momento correspondiente a la última evaluación evaluable de la SSP por el CRI.
    Se estimará la distribución de los tiempos de SSP empleando el método del límite de producto de Kaplan-Meier. Se estimará la SSP media junto con el IC bilateral del 95 % asociado. Se utilizará un modelo de riesgos proporcionales de Cox para estimar el cociente de riesgos y el IC del 95% entre subgrupos.
    ● Tasa de control de la enfermedad (TCE) conforme a la evaluación del CRI
    TCE es la proporción de pacientes que alcanzan una respuesta objetiva o que mantienen estable la enfermedad durante al menos 24semanas.
    Se realizarán análisis similares a los descritos para la TRO
    ● Supervivencia Global (SG)
    SG equivale al tiempo desde el D1C1 hasta la muerte por cualquier causa.
    Se dará seguimiento a los pacientes para su supervivencia durante un máximo de 24 meses a partir de la fecha del C1D1 a menos que se produzca la muerte, se pierda el seguimiento o se cierre el estudio.
    El análisis de SG se realizará como se describe para SSP. Además, se estimará la SG a un año y dos años junto con un IC del 95%.

    Análisis de la eficacia respecto a las metástasis en el SNC:
    ● TRO SNC conforme a la evaluación del CRI del SNC en pacientes con metástasis en el SNC al Inicio
    TRO SNC=proporción de pacientes con metástasis del SNC al inicio del estudio que logran una mejor respuesta RC o RP basada en las lesiones del SNC.
    ● DR SNC conforme a la evaluación del CRI del SNC en pacientes con metástasis en el SNC al inicio
    DR SNC= tiempo desde la fecha de la primera evaluación del tumor con una respuesta documentada (RC o RP), hasta la fecha de progresión de la enfermedad o la muerte, en pacientes con metástasis del SNC al inicio del estudio.
    Se utilizarán las mismas normas y normas de censura aplicadas a la SSP.
    Las estadísticas de Kaplan-Meier seguirán aquellas indicadas para la SSP.
    ● SSP SNC conforme a la evaluación del CRI del SNC en pacientes con metástasis en el SNC al inicio o antecedentes de metástasis en el SNC y en la población por intención de tratar (ITT)
    SSP SNC: se analizará utilizando el método de límite de producto de Kaplan-Meier según el análisis primario de SSP en pacientes con metástasis del SNC al inicio o con un historial de metástasis del SNC y en la población de ITT según los lugares de la enfermedad en el SNC y en todas las localizaciones de la enfermedad.
    Si no se realizaron exploraciones cerebrales al inicio y en los puntos temporales posteriores, se supondrá que los pacientes están libres de la enfermedad del SNC en esos puntos temporales respectivos.
    ● SG SNC en pacientes con metástasis en el SNC al inicio o antecedentes de metástasis en el SNC
    SG SNC: se analizará utilizando el método de límite de producto de Kaplan-Meier según el análisis primario SSP en pacientes con metástasis del SNC al inicio del estudio o con un historial de metástasis del SNC.

    Análisis de la seguridad:
    ● Acontecimientos adversos (AA), que incluyen las muertes y otros acontecimientos adversos graves (AAG)
    Los acontecimientos adversos surgidos durante el tratamiento (AAST) Son aquellos AA que ocurren o empeoran durante o después de la primera administración de cualquier tratamiento del estudio y hasta 30 días después de la última administración de cualquier tratamiento del estudio.. Los acontecimientos adversos surgidos durante el tratamiento (AAST) se clasificarán según la versión 5.0 de los CTCAE del NCI, se agruparán por término preferente del Diccionario médico para actividades reguladoras (Medical Dictionary for Regulatory Activities, MedDRA) y se resumirán por el peor grado de intensidad por paciente.
    Se presentará un resumen de los AA. Se tabularán y resumirán los AAST que den lugar a la interrupción del tratamiento del estudio o a cualquier otra interrupción anticipada. Se tabularán y resumirán las muertes debido a AA y las muertes por cualquier causa distinta a la progresión de la enfermedad. Las muertes debido a la progresión de la enfermedad no se capturarán como AAG.
    ● Anomalías clínicas de laboratorio
    (...)

    E.5.2.1Timepoint(s) of evaluation of this end point
    No interim analyses for purposes of early stoppage of the Study are planned.

    The projected timing for evaluation of secondary endpoints (relative to Study initiation) is summarized here:

    SECONDARY EFFICACY ENDPOINTS:
    - DoR: approx. 2-2.5 years
    - PFS: approx. 2-2.5 years
    - DCR: approx. 2-2.5 years
    - OS: approx. 3-3.5 years

    CNS METASTASES EFFICACY ENDPOINTS:
    - CNS ORR: approx. 2-2.5 years
    - CNS DoR: approx. 2-2.5 years
    - CNS PFS: approx. 2-2.5 years
    - CNS OS: approx. 3-3.5 years

    SAFETY ENDPOINTS:
    - Incidence of TEAEs: approx. 3-3.5 years
    - Incidence of clinical laboratory abnormalities: approx. 3-3.5 years

    PHARMACOKINETIC ENDPOINTS:
    - Cmax and AUC of tesetaxel: approx. 2-2.5 years
    - Cmax and AUC of capecitabine and 5-FU: approx. 2-2.5 years
    No se han previsto análisis intermedios para la interrupción anticipada.
    Se resume el calendario previsto para la evaluación de los criterios de valoración secundarios
    VARIABLES PRINCIPALES DE EVALUACIÓN DE EFICACIA SECUNDARIA:
    DR: aprox.2-2,5 años
    SSP: aprox.2-2,5 años
    TCE: aprox.2-2,5 años
    SG: aprox 3-3,5 años

    VARIABLES PRINCIPALES DE EVALUACIÓN DE EFICACIA DE LAS METÁSTASIS DEL CNS:
    SNC TRO: aprox.2-2,5 años
    SNC DR: aprox.2-2,5 años
    SNC SSP: aprox.2-2,5 años
    SNC SG: aprox.3-3,5 años

    PUNTOS FINALES DE SEGURIDAD:
    - Incidencia de las TEAEs: aprox. 3-3,5 años
    - Incidencia de anomalías en el laboratorio clínico: aprox. 3-3,5 años

    PUNTOS FINALES FARMACOCINÉTICOS:
    - Cmáx y AUC de tesetaxel: aprox. 2-2,5 años
    - Cmax y AUC de capecitabina y 5-FU: aprox. 2-2,5 años
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    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 No
    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 concerned3
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    Korea, Republic of
    Spain
    Taiwan
    Ukraine
    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
    The end of Study or the last visit of the last patient is planned for two years after the last patient initiates treatment.
    El final del estudio o la última visita del último paciente se planifica para dos años después desde que el último paciente inicie el tratamiento.
    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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 125
    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)
    Standard care
    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 Decision2019-06-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-13
    P. End of Trial
    P.End of Trial StatusOngoing
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