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    Summary
    EudraCT Number:2017-003019-21
    Sponsor's Protocol Code Number:IMMU-132-05
    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:2017-10-24
    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 number2017-003019-21
    A.3Full title of the trial
    An International, Multi-Center, Open-Label, Randomized, Phase III Trial of Sacituzumab Govitecan versus Treatment of Physician Choice in Patients with Metastatic Triple-Negative Breast Cancer Who Received at Least Two Prior Treatments
    Estudio en fase III, internacional, multicéntrico, abierto, aleatorizado, de sacituzumab govitecan (IMMU-132) frente al tratamiento elegido por el médico en pacientes con cáncer de mama triple negativo metastásico que recibieron al menos dos tratamientos previos
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to compare the study drug IMMU-132 with standard treatments in Metastatic Triple-Negative Breast Cancer patients Who have Received at Least Two Prior Treatments.
    Un estudio para comparar el fármaco de estudio IMMU-132 con el tratamiento estándar en pacientes con cáncer de mama triple negativo metastásico que recibieron al menos dos tratamientos previos
    A.4.1Sponsor's protocol code numberIMMU-132-05
    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 SponsorImmunomedics, 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 supportImmunomedics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationImmunomedics, Inc.
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street Address300 The American Road
    B.5.3.2Town/ cityMorris Plains,
    B.5.3.3Post codeNJ 07950
    B.5.3.4CountryUnited States
    B.5.5Fax number+353 1 246 0699
    B.5.6E-maildwhiteley@immunomedics.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 nameSacituzumab govitecan
    D.3.2Product code IMMU-132, hRS7-SN38
    D.3.4Pharmaceutical form 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 INNsacituzumab govitecan
    D.3.9.1CAS number 1491917-83-9
    D.3.9.2Current sponsor codeSacituzumab Govitecan
    D.3.9.3Other descriptive nameIMMU-132, hRS7-SN38
    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) 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 Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Halaven
    D.2.1.1.2Name of the Marketing Authorisation holderEisai 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 nameEribulin
    D.3.2Product code L01XX41
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEribulin
    D.3.9.1CAS number 441045-17-6
    D.3.9.3Other descriptive nameERIBULIN MESYLATE
    D.3.9.4EV Substance CodeSUB31126
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.44
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Xeloda
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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 namecapecitabine
    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.3.9.3Other descriptive nameCAPECITABINE
    D.3.9.4EV Substance CodeSUB12474MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Gemzar
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi Oncology Plc.
    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 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 hydrochloride
    D.3.9.1CAS number 122111-03-9
    D.3.9.3Other descriptive nameGEMCITABINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB02324MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number38
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 5
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Navelbine
    D.2.1.1.2Name of the Marketing Authorisation holderPIERRE FABRE IBÉRICA, S.A.
    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 nameVinorelbine
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVinorelbine tartrate
    D.3.9.1CAS number 71486-22-1
    D.3.9.4EV Substance CodeSUB00069MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.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
    Relapsed/Refractory Triple-Negative Breast Cancer
    Cáncer de mama triple negativo metastásico resistente o recidivante
    E.1.1.1Medical condition in easily understood language
    Triple-Negative breast cancer who has progressed or returned
    Cáncer de mama triple negativo que ha progresado o regresado
    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 10075566
    E.1.2Term Triple negative 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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10027475
    E.1.2Term Metastatic breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10006198
    E.1.2Term Breast cancer recurrent
    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
    The primary objective of this study is to compare the efficacy of sacituzumab govitecan to the treatment of physician’s choice (TPC) as measured by progression-free survival (PFS) in patients with metastatic TNBC previously treated with at least two systemic chemotherapy regimens.
    El objetivo principal de este estudio es comparar la eficacia de sacituzumab govitecan con el tratamiento elegido por el médico (TEM) determinada por la supervivencia libre de progresión (SLP) en pacientes con CMTN metastásico tratados previamente con al menos dos pautas quimioterapéuticas sistémicas.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to compare between the two treatment groups for:
    - Overall Survival (OS)
    - Independently-determined Objective Response Rate (ORR), duration of response and time to onset of response per RECIST 1.1 criteria
    - Quality of life
    - Safety (adverse events, safety laboratories, incidence of dose delays and dose reductions, treatment discontinuations due to adverse events)
    Los objetivos secundarios del estudio son comparar entre los dos grupos de tratamiento:
    - La supervivencia global (SG)
    - La tasa de respuesta objetiva (TRO) determinada independientemente, la duración de la respuesta y el tiempo hasta el inicio de la respuesta según los criterios RECIST 1.1
    - La calidad de vida
    - La seguridad (acontecimientos adversos, análisis de seguridad, incidencia de retrasos en la administración de la dosis y reducciones de la dosis, interrupciones del tratamiento debido a acontecimientos adversos)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Female or male patients, >18 years of age, able to understand and give written informed consent.
    • Histologically or cytologically confirmed TNBC per ASCO/CAP criteria, based on the most recent analyzed biopsy or other pathology specimen.
    • Metastatic disease documented by CT or MRI imaging.
    • Measurable disease by CT or MRI as per RECIST 1.1. Bone-only disease is not permitted.
    • Brain MRI must be done for patients with brain metastasis and patient must have had stable CNS disease for at least 4 weeks
    • At least 2 weeks beyond high dose systemic corticosteroids (however, low dose corticosteroids ≤ 20 mg prednisone or equivalent daily are permitted provided the dose is stable for 4 weeks).
    • Refractory to or relapsed after at least two prior standard of care chemotherapy regimens for unresectable, locally advanced or metastatic breast cancer. (These regimens will qualify regardless of triple-negative status at the time they were given. There is no upper limit in the number of prior chemotherapies and earlier adjuvant or neoadjuvant therapy for more limited disease will qualify as one of the required prior regimens if the development of unresectable, locally advanced or metastatic disease occurred within a 12-month period of time after completion of chemotherapy).
    • All patients must have been previously treated with a taxane regardless of disease stage (adjuvant, neoadjuvant or advanced) when it was given.
    • Eligible for one of the chemotherapy options listed as TPC (Eribulin, capecitabine, gemcitabine, or vinorelbine) as per investigator assessment.
    • ECOG performance score of 0 or 1.
    • Adequate hematology without ongoing transfusional support (hemoglobin > 9 g/dL, ANC > 1,500 per mm3, platelets > 100,000 per mm3).
    • Adequate renal and hepatic function (creatinine clearance of > 60 ml/min, may be calculated using Cockcroft-Gault equation; bilirubin ≤ 1.5 IULN, AST and ALT ≤ 3.0 x IULN or 5 x IULN if known liver metastases).
    • Recovered from all toxicities to Grade 1 or less by NCI CTCAE v4.00 (except alopecia or peripheral neuropathy that may be Grade 2 or less) at the time of randomization. Patients with Grade 2 neuropathy are eligible but may not receive vinorelbine as TPC.
    • Patients must have completed all prior cancer treatments at least 2 weeks prior to randomization including chemotherapy (includes also endrocrine treatment), radiotherapy and major surgery. Note: Prior antibody treatment for cancer must have been completed at least 3 weeks prior to randomization.
    • Prior investigational agents are permitted, provided completion according to the timeframes above.
    - Varones o mujeres, ≥ 18 años de edad, que puedan entender y otorgar el consentimiento informado por escrito.
    - CMTN confirmado histológica o citológicamente conforme a los criterios ASCO/CAP, en base a la biopsia más reciente analizada u otra muestra patológica.
    - Enfermedad metastásica verificada mediante TAC o RM.
    - Enfermedad mensurable mediante TAC o RM conforme a los criterios RECIST 1.1. No se permite la enfermedad exclusivamente ósea.
    - A los pacientes con metástasis cerebral se les debe realizar una RM del cerebro y los pacientes deben haber tenido enfermedad del SNC estable durante al menos 4 semanas.
    - Al menos 2 semanas después de recibir corticoesteroides sistémicos en dosis altas (sin embargo, se permiten corticoesteroides en dosis bajas de ≤ 20 mg de prednisona o equivalente diariamente siempre que la dosis permanezca estable durante 4 semanas).
    - Resistente o recidivante después de al menos dos pautas de quimioterapia de referencia previas para el cáncer de mama irresecable, localmente avanzado o metastásico (Anexo 1). (Estas pautas se tomarán en consideración con independencia del estado triple negativo en el momento en que fueron administradas. No hay un límite máximo en el número de quimioterapias previas, y el tratamiento adyuvante o neoadyuvante previo para la enfermedad más limitada se considerará como una de las pautas previas requeridas si la aparición de la enfermedad irresecable, localmente avanzada o metastásica se produjo en un periodo de 12 meses tras la finalización de la quimioterapia).
    - Todos los pacientes deben haber sido tratados previamente con un taxano con independencia de la fase de la enfermedad (adyuvante, neoadyuvante o avanzada) cuando se administró.
    - Aptos para una de las opciones de quimioterapia incluidas como TEM (eribulina, capecitabina, gemcitabina, o vinorelbina) según la evaluación del investigador.
    - Puntuación del estado funcional de 0 o 1según el ECOG (Anexo 2).
    - Una hematología adecuada sin el apoyo de transfusiones en curso (hemoglobina > 9 g/dl, RAN > 1500 por mm3, plaquetas > 100.000 por mm3).
    - Funciones renal y hepática adecuadas (aclaramiento de creatinina de > 60 ml/min, puede calcularse mediante la ecuación de Cockcroft-Gault; bilirrubina ≤ 1,5 LSNI, AST y ALT ≤ 3,0 x LSNI o 5 x LSNI si hay metástasis hepáticas conocidas).
    - Recuperados de todas las toxicidades a grado 1 o inferior según los CTCAA del NCI v4.00 (excepto alopecia o neuropatía periférica que pueden ser de grado 2 o inferior) en el momento de la aleatorización. Los pacientes con neuropatía de grado 2 son aptos pero no pueden recibir vinorelbina como TEM.
    - Los pacientes deben haber completado todos los tratamientos antineoplásicos previos al menos 2 semanas* antes de la aleatorización, incluida la quimioterapia (también incluye el tratamiento endocrino), radioterapia y cirugía mayor. *El tratamiento previo con anticuerpos contra el cáncer debe haberse completado al menos 3 semanas antes de la aleatorización.
    - Se permite el uso previo de fármacos experimentales, siempre que la finalización esté conforme con los plazos indicados anteriormente.
    E.4Principal exclusion criteria
    • Women who are pregnant or lactating.
    • Women of childbearing potential or fertile men unwilling to use effective contraception during study until conclusion of 4-week post-treatment evaluation period.
    • Patients with Gilbert’s disease.
    • Presence of bulky disease (defined as any single mass > 7 cm in its greatest dimension).
    • Patients with non-melanoma skin cancer or carcinoma in situ of the cervix are eligible, while patients with other prior malignancies must have had at least a 3-year disease-free interval.
    • Patients known to be HIV positive, hepatitis B positive, or hepatitis C positive.
    • Known history of unstable angina, MI, or CHF present within 6 months of randomization or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy.
    • Known history of clinically significant active COPD, or other moderate-to-severe chronic respiratory illness present within 6 months of randomization.
    • Prior history of clinically significant bleeding, intestinal obstruction, or GI perforation within 6 months of randomization.
    • Infection requiring antibiotic use within one week of randomization.
    • Patients with a history of an anaphylactic reaction to irinotecan.
    • Other concurrent medical or psychiatric conditions that, in the Investigator’s opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.
    - Mujeres que estén embarazadas o en período de lactancia.
    - Mujeres con capacidad para procrear o varones fértiles que no estén dispuestos a utilizar un método anticonceptivo eficaz durante el estudio hasta la conclusión del período de evaluación posterior al tratamiento de 4 semanas.
    - Pacientes con la enfermedad de Gilbert.
    - Presencia de neoplasia maligna con gran masa tumoral (definida como cualquier masa única > 7 cm en su dimensión máxima).
    - Los pacientes con cáncer de piel no melanómico o carcinoma in situ del cuello uterino son aptos, mientras que los pacientes con otras neoplasias malignas previas deben haber tenido al menos un intervalo sin enfermedad de 3 años.
    - Los pacientes que se sabe que son positivos para VIH, positivos para hepatitis B o positivos para hepatitis C.
    - Antecedentes conocidos de angina de pecho inestable, IM o ICC presente en los 6 meses previos a la aleatorización o arritmia cardíaca clínicamente significativa (distinta de fibrilación auricular estable) que requiera tratamiento antiarrítmico.
    - Antecedentes conocidos de EPOC activa clínicamente significativa u otra enfermedad respiratoria crónica moderada o grave en los 6 meses previos a la aleatorización.
    - Antecedentes previos de hemorragia clínicamente significativa, obstrucción intestinal o perforación digestiva en los 6 meses previos a la aleatorización.
    - Infección que requiera el uso de antibióticos en el plazo de una semana antes de la aleatorización.
    - Pacientes con antecedentes de una reacción anafiláctica a irinotecán.
    - Otras enfermedades o trastornos psiquiátricos concurrentes que, en opinión del investigador, es probable que puedan confundir la interpretación del estudio o impedir la realización de los procedimientos del estudio y los exámenes de seguimiento.
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival (PFS) as determined by an independent centralized blinded assessment.
    Supervivencia libre de progresión (SLP) según lo determinado por una evaluación enmascarada centralizada e independiente.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Monitored throughout the study
    Monitorizada a lo largo del estudio
    E.5.2Secondary end point(s)
    - Overall survival (OS)
    - Objective response rate (ORR), duration of response, and time to onset of response
    - Quality of life
    - Safety, including: adverse events; safety laboratories and evaluations; incidence of dose delays and dose reductions; and treatment discontinuations due to adverse events
    - La supervivencia global (SG)
    - La tasa de respuesta objetiva (TRO), la duración de la respuesta y el tiempo hasta el inicio de la respuesta
    - La calidad de vida
    - La seguridad, incluidos: acontecimientos adversos, evaluaciones y análisis de seguridad, incidencia de retrasos en la administración de la dosis y reducciones de la dosis, e interrupciones del tratamiento a causa de los acontecimientos adversos
    E.5.2.1Timepoint(s) of evaluation of this end point
    Monitored throughout the study
    Monitorizada a lo largo del estudio
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA54
    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
    Belgium
    Canada
    France
    Germany
    Ireland
    Italy
    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
    UVUP
    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 months1
    E.8.9.1In the Member State concerned days16
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days16
    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: 263
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 65
    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 state33
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 175
    F.4.2.2In the whole clinical trial 328
    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)
    After discontinuing the study, the patient may not receive any more sacituzumab govitecan; otherwise, there is no restriction on subsequent therapies or interventions that a patient may receive.
    No se permitirá el cruce al tratamiento con sacituzumab govitecan tras la interrupción del tratamiento en el grupo de TEM pero, por lo demás, no hay ninguna restricción en cuanto a los tratamientos posteriores que un paciente puede recibir después de interrumpir el estudio.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation National Institute for Health Research (NIHR)
    G.4.3.4Network Country United Kingdom
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Cancer Trials Ireland (CTI)
    G.4.3.4Network Country Ireland
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-12-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-22
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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