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    Summary
    EudraCT Number:2021-005743-79
    Sponsor's Protocol Code Number:GS-US-592-6238
    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:2022-04-19
    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 number2021-005743-79
    A.3Full title of the trial
    A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1.
    Estudio de fase III, aleatorizado, abierto de sacituzumab govitecán frente al tratamiento elegido por el médico en pacientes con cáncer de mama triple negativo localmente avanzado, inoperable o metastásico, no tratado anteriormente cuyos tumores no presenten expresión de PD-L1 o en pacientes tratados previamente con agentes anti PD(L)1 en fase inicial cuyos tumores presenten expresión de PD-L1
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Participants with Previously Untreated Locally Advanced, Inoperable (cannot be removed surgically), or Metastatic (spread to other locations in the body) Triple Negative Breast Cancer (breast cancer that does not have receptors for Oestrogen and progesterone hormones or HER2 proteins).
    Un estudio de Sacituzumab Govitecan frente al tratamiento elegido por el médico en pacientes con cáncer de mama triple negativo (cáncer de mama que sin receptores para hormonas de estrógeno y progesterona o proteínas HER2) sin tratamiento previo, localmente avanzado, inoperable (que no puede ser extirpado mediante cirugía) o metastásico (que se ha extendido a otras partes del cuerpo).
    A.4.1Sponsor's protocol code numberGS-US-592-6238
    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 SponsorGilead Sciences, 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 supportGilead Sciences, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGilead Sciences International Ltd.
    B.5.2Functional name of contact pointClinical Trials Mailbox
    B.5.3 Address:
    B.5.3.1Street AddressFlowers Building, Granta Park
    B.5.3.2Town/ cityAbington, Cambridge
    B.5.3.3Post codeCB21 6GT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441223897284
    B.5.6E-mailclinical.trials@gilead.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 Yes
    D.2.1.1.1Trade name Trodelvy
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences Ireland UC
    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 nameSacituzumab govitecan
    D.3.2Product code IMMU-132
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSACITUZUMAB GOVITECAN
    D.3.9.2Current sponsor codeIMMU-132
    D.3.9.4EV Substance CodeSUB191213
    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 No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Paclitaxel 6 mg/ml concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi Deutschland GmbH
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 namePaclitaxel
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPaclitaxel
    D.3.9.3Other descriptive namePACLITAXEL
    D.3.9.4EV Substance CodeSUB179428
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 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 Abraxane 5 mg/ml powder for dispersion for infusion
    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 namenab-Paclitaxel
    D.3.4Pharmaceutical form Powder for dispersion 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 INNnab-Paclitaxel
    D.3.9.3Other descriptive namePACLITAXEL ALBUMIN-BOUND
    D.3.9.4EV Substance CodeSUB127678
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) 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 Yes
    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 Gemcitabin Aurobindo concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderAurobindo Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 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 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/ml milligram(s)/millilitre
    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 Carboplatin 10 mg/ml concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi Deutschland GmbH
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 nameCarboplatin
    D.3.4Pharmaceutical form 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 INNCARBOPLATIN
    D.3.9.3Other descriptive nameCARBOPLATIN
    D.3.9.4EV Substance CodeSUB06614MIG
    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
    Programmed cell death ligand 1 (PD-L1) negative metastatic triple-negative breast cancer or PD-L1-positive metastatic triple-negative breast cancer previously treated with an anti-PD-(L)1 agent in the curative setting.
    Cáncer de mama triple negativo metastásico con muerte celular programada del ligando 1 (PD-L1) o cáncer de manma triple negativo PD-L1 positivo metastásico tratado previamente con un agente anti PD-(L)1 con intención curativa.
    E.1.1.1Medical condition in easily understood language
    Triple Negative Breast Cancer (breast cancer that does not have receptors for Oestrogen and Progesterone hormones or HER2 proteins).
    Cáncer de mama triple negativo (cáncer de mama que no tiene receptores para hormonas de estrógeno o progesterona o proteínas HER2)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10084066
    E.1.2Term Triple negative breast cancer metastatic
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare progression-free survival (PFS) as assessed by BICR between sacituzumab govitecan versus treatment of physician’s choice.
    Comparar la supervivencia sin progresión (SSP) evaluada mediante una evaluación central independiente enmascarada (ECIE) entre sacituzumab govitecán (SG) y el tratamiento elegido por el médico.
    E.2.2Secondary objectives of the trial
    -To compare overall survival between the 2 arms
    -To compare objective response rate as assessed by blinded independent central review (BICR) between the 2 arms
    -To compare duration of response as assessed by BICR between the 2 arms
    -To compare time to onset of response as assessed by BICR between the 2 arms
    -To compare safety and tolerability between the 2 arms
    -To compare mean change from baseline in the physical functioning domain as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core Questionnaire, Version 3.0 (EORTC QLQ-C30) between the 2 arms
    - Comparar la supervivencia global (SGl) entre los 2 grupos
    - Comparar la tasa de respuesta objetiva (TRO) entre los 2 grupos, evaluada mediante una ECIE
    - Comparar la duración de la respuesta (DdR) entre los 2 grupos, evaluada mediante una ECIE
    - Comparar el tiempo hasta la respuesta (ThR) entre los 2 grupos, evaluado mediante una ECIE
    - Comparar la seguridad y la tolerabilidad entre los 2 grupos
    - Comparar el cambio medio respecto al inicio en el dominio de la función física, medido mediante el cuestionario de calidad de vida de la Organización Europea para la Investigación y el Tratamiento del Cáncer, cuestionario básico, versión 3.0 (EORTC QLQ-C30) entre los 2 grupos
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet all of the following inclusion criteria to be eligible for participation in this study (no waivers for patient eligibility will be offered or permitted):

    1) Female or male patients, regardless of race and ethnic group, who are 18 years of age or older, able to understand and give written informed consent.

    2) Patients with locally advanced, inoperable, or metastatic TNBC who have not received previous systemic therapy for advanced disease and whose tumors are PD-L1 negative at screening. Alternatively, patients whose tumors are PD-L1 positive at screening will be eligible if they received an anti-programmed death (ligand) 1 (anti-PD-[L]1) inhibitor (ie, checkpoint inhibitor) in the adjuvant or neoadjuvant setting.

    3) Have provided representative formalin-fixed paraffin-embedded (FFPE) tumor specimen in blocks (preferred) or have at least 20 to 25 freshly sectioned unstained slides from fresh biopsy tissue (preferred) or archival tissue block for central testing of ER, progesterone receptor, HER2, and PD-L1 and additional biomarker testing. A baseline biopsy is required if archival tissue is not available and this procedure must be performed prior to the first dose of study treatment and after the patient provides written informed consent. Fine needle aspirates and bone biopsies are not suitable samples.

    4) ECOG performance status score of 0 or 1

    5) Life expectancy ≥ 3 months

    6) Recovered from major surgery for ≥ 2 weeks

    7) Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study treatment initiation (hemoglobin ≥ 9 g/dL, ANC ≥ 1500/mm3, and platelets ≥ 100,000/μL).

    8) Adequate hepatic function (bilirubin ≤ 1.5 x ULN, AST and ALT ≤ 2.5 x ULN or ≤ 5 x ULN if known liver metastases, and serum albumin > 3 g/dL).

    9) Creatinine clearance ≥ 30 mL/min as assessed by the Cockcroft-Gault equation.

    10) International Normalized Ratio (INR)/PT and PTT or aPTT ≤ 1.5 ULN unless patient is currently receiving therapeutic anticoagulant therapy.

    11) Male patients and female patients of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception as described in protocol Appendix 3.

    12) Patients with HIV must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/ disease
    Los pacientes deben cumplir los criterios de inclusión siguientes para ser elegibles para participar en el estudio (no se ofrecerán ni permitirán dispensas):
    1) Hombres o mujeres sin importar la raza u origen étnico mayores de 18 años capaces de comprender y dar su consentimiento por escrito.
    2) Pacientes con cáncer de mama triple negativo localmente avanzado, inoperable o metastásico que no han recibido terapia sistémica previa para enfermedad avanzada y cuyos tumores son PD-L1 negativo en la selección. Alternativamente, los pacientes cuyos tumores son PD-L1 positivo en selección serán elegibles si recibieron un inhibidor anti PD-L1 (p.ej. un inhibidor de punto de control) en la terapia adyuvante o neo adyuvante.
    3) Haber proporcionado un especímen de tumor en bloque (preferido) enbebido en parafina y fijado en formalín tener al menos entre 20 y 25 láminas frescas de una biopsia reciente o un bloque de tumor de archivo para análisis central de ER, receptor de progesterona, HER2, PD-L1 y biomarcadores adicionales. Se requiere una biopsia en selección si no hay tejido de archivo disponible y esta debe realizarse antes de la primera dosis del tratamiento en estudio y después del consentimiento escrito del paciente. Los aspirados con aguja fina y las biopsias óseas no son muestras válidas.
    4) Puntuación en la escala ECOG de 0 ó 1
    5) Esperanza de vida ≥ 3 meses.
    6) Recuperado de cirugía mayor desde al menos hace 2 semanas
    7) Conteo hematológico adecuado sin transfusión o soporte al factor de crecimiento dentro de las 2 semanas del comienzo del tratamiento del estudio (hemoglobina ≥ 9 g/dL, ANC ≥ 1500/mm3, y plaquetas ≥ 100,000/μL).
    8) Función hepática adecuada (bilirrubina≤ 1.5 x ULN, AST y ALT ≤ 2.5 x ULN or ≤ 5 x ULN si hay metástasis hepática conocida, y albúmina en suero > 3 g/dL).
    9) Aclaramiento de la creatinina ≥ 30 mL/min según la ecuación de Cockcroft-Gault.
    10) INR)/PT y PTT o aPTT ≤ 1.5 ULN a menos que el paciente esté recibiendo terapia terapeútica anticoagulante.
    11) Hombres y mujeres en edad de procrear heterosexuales deben acceder a utilizar los métodos anticonceptivos definidos en el protocolo o bien según se describe en el apéndice 3 del protocolo.
    12) Los pacientes con VIH deben estar con terapia antirretroviral y tener la infección/patología bien controlada.
    E.4Principal exclusion criteria
    Patients who meet any of the following exclusion criteria are not eligible to be enrolled in this study (no waivers for patient eligibility will be offered or permitted):

    1) Positive serum pregnancy test or women who are lactating.

    2) Known or severe (≥ Grade 3) hypersensitivity or allergy to sacituzumab govitecan and/or the chemotherapy regimen of choice in the TPC arm (eg, nab-paclitaxel, paclitaxel, gemcitabine, or Carboplatin), their metabolites, or formulation excipient.

    3) Requirement for ongoing therapy with or prior use of any prohibited medications listed in section 5.6.1 of the protocol.

    4) Patients may not have received systemic anticancer treatment within the previous 6 months or radiation therapy within 2 weeks prior to enrollment. Patients must have recovered (ie, > Grade 2 is considered not recovered) from AEs due to a previously administered agent at the time of study entry.
    - Note: patients with any grade neuropathy or alopecia are an exception to this criterion and will qualify for the study.
    - Note: if patients received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.

    5) Patients may not be participating in a study with an investigational agent or investigational device within 4 weeks prior to randomization. Patients participating in observational studies are eligible.

    6) Have previously received topoisomerase 1 inhibitors or antibody drug conjugates containing a topoisomerase inhibitor.

    7) Have an active second malignancy.

    8) Have known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate (with the exception of those treated with chemotherapy) provided they have stable CNS disease (defined as radiographic stability demonstrated with a minimum of 2 posttreatment brain imaging assessments; one performed during screening) for at least 4 weeks prior to enrollment and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases, and have also been clinically stable for at least 2 weeks while taking ≤ 10 mg/day of prednisone or its equivalent. All patients with carcinomatous meningitis are excluded regardless of clinical stability.

    9) Met any of the following criteria for cardiac disease:
    a) Myocardial infarction or unstable angina pectoris within 6 months of enrollment.
    b) History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication); history of QT interval prolongation.
    c) New York Heart Association Class III or greater congestive heart failure or known left ventricular ejection fraction of < 40%.

    10) Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease) or GI perforation within 6 months of enrollment.

    11) Have active serious infection requiring antibiotics.

    12) Patients positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.

    13) Have active HBV (defined as having a positive HbsAg test) or HCV.

    14) Have 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.

    15) Has received a live vaccine within 30 days prior to randomization.
    Los pacientes que cumplan cualquiera de los siguientes criterios de exclusión no son elegibles para participar en este estudio ( (no se ofrecerán ni permitirán dispensas):
    1) Test de embarazo positivo en suero o mujeres lactantes.
    2) Hipersensibilidad o alergia a sacitumumab govitecan conocida o severa (≥ Grado 3) y/o al régimen de quimioterapia elegido en el brazo de tratamiento asignado por el doctor (ej. nab-paclitaxel, paclitaxel, gemcitabina o carboplatino), sus metabolitos o excipientes en su formulación.
    3) No estar recibiendo o haber recibido terapia con alguna medicación prohibida de las listadas en la sección 5.6.1 del protocolo.
    4) Los pacientes no deben haber recibido tratamiento sistémico anticáncer en los 6 meses siguientes o radioterapia en las 2 semanas anteriores a la selección. Los pacientes deben haberse recobrado (ej: > Grado 2 no se considera recobrado) de AEs debido a un agente previamente administrado al entrar en el estudio.
    - Nota: los pacientes con neuropatía o alopecia de cualquier grado son una excepción y pueden cualificar para el estudio.
    - Nota: si los pacientes se sometieron a cirugía mayor, deben haberse recobrado adecuadamente de la toxicidad y/o complicaciones de la intervención antes de comenzar la terapia.
    5) Los pacientes no deben estar participando en un estudio con un agente en investigación o producto sanitario en investigación en las 4 semanas anteriores a la aleatorización. Los pacientes que participen en estudios observacionales son elegibles.
    6) Haber recibido con anterioridad inhibidores de la topoisomerasa 1 o anticuerpos conjugados que contengan un inhibidor de la topoisomerasa.
    7) Tener una segunda malignidad activa
    8) Tener metástasis conocida en el sistema nervioso central (SNC) y/o meningitis carcinomatosa. Los pacientes con metástasis cerebral previamente tratada pueden participar (con la excepción de aquellos tratados con quimioterapia) si tienen enfermedad el el SNC estable (definida como estabilidad radiográfica demostrada mediante al menos 2 evaluaciones por imagen tras el tratamiento; una realizada durante la selección) durante al menos 4 semanas anter de la inclusión y todos los síntomas neurológicos han regresado a la selección, no hay evidencia de metastasis nueva o metástasis cerebral mayor y han permanecido clinicamente estables durante al menos 2 semanas mientras reciben ≤ 10 mg/día de prednisona o su equivalente. Todos los pacientes con meningitis carcinomatosa están excluidos sin importar la estabilidad clínica.
    9) Cumplir cualquiera de los siguientes criterios para enfermedad cardíaca:
    a) Infarto de miocardio o angina de pecho inestable en los 6 meses anteriores a la inclusión.
    b) Historial de arritmia ventricular grave (p.ej.: taquicardia ventricular o fibrilación ventricular), bloqueo atrioventricular de alto grado u otras arritmias cardiacas que requieran medicación antiarrítmica (excepto para fibrilación atrial bien controlada con medicación antiarrítmica); historia de intervalo QT prolongado.
    c) Fallo cardiaco congestivo de grado III o mayor según la escala de la New York Heart Association o eyección ventricular izquierda conocida < 40%.
    10) Tener inflamación intestinal crónica (colitis ulcerosa, enfermedad de Crohn) o perforación gastrointestinal los 6 meses anteriores a la inclusión.
    11) Tener infección grave activa que requiera antibióticos.
    12) Pacientes con VIH-1 ó 2 positivo con historial de sarcoma de Kaposi y/o enfermedad multicentrica de Castleman.
    13) Tener VHB activa (definida como tener un test positivo en HbsAg) o VHC.
    14) Tener otra condición médica o psiquiátrica concurrente que, a juicio del investigador, pueda confundir la interpretación del estudio o impedir la realización completa de los procedimientos del estudio y evaluaciones de seguimiento.
    15) Haber recibido una vacuna con virus vivos en los 30 días anteriores a la aleatorización
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival (PFS) , time from the date of randomization until the date of objective progressive disease (PD), as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, or death (whichever comes first).
    Supervicencia sin progresión (SSP), tiempo desde la fecha de aleatorización hasta la fecha de de progresión objetiva de la enfermedad (PE), evaluada mediante una ECIE según los criterios de evaluación de la respuesta en tumores sólidos (RECIST) versión 1.1, o la muerte (lo que ocurra antes).
    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) is defined as the time from the date of randomization until death due to any cause.
    - objective response rate (ORR) is defined as the proportion of patients who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response as assessed by BICR per RECIST Version 1.1.
    - Duration of response (DOR) is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of definitive PD or death from any cause (whichever comes first) as assessed by BICR per RECIST Version 1.1.
    - Time to onset of response (TTR) is defined as the time from the date of randomization until the first documentation of CR or PR as assessed by BICR per RECIST Version 1.1.
    - Incidence of treatment-emergent AEs (TEAEs) and clinical laboratory abnormalities.
    - Time to deterioration (TTD) of global health status/quality of life (QOL), pain, and fatigue subscale domains of the EORTC QLQ-C30
    - La SGl se define como el tiempo transcurrido desde la fecha de la aleatorización hasta la muerte por cualquier causa.
    - La TRO se define como la proporción de pacientes que logran una respuesta completa (RC) o una respuesta parcial (RP) que se confirma al menos 4 semanas después de la documentación inicial de la respuesta, evaluada mediante una ECIE según los RECIST versión 1.1.
    - La DdR se define como el tiempo transcurrido entre la primera documentación de RC o RP y la primera documentación de PE definitiva o muerte por cualquier causa (lo que ocurra antes), evaluada mediante una ECIE según los RECIST versión 1.1.
    - El ThR se define como el tiempo transcurrido desde la fecha de la aleatorización hasta la primera documentación de RC o RP, evaluado mediante una ECIE según los RECIST versión 1.1.
    - ncidencia de acontecimientos adversos surgidos durante el tratamiento (AAST) y resultados anormales en los análisis clínicos.
    - Cambio medio respecto al inicio en el dominio de la función física del EORTC QLQ-C30
    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 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) 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 No
    E.8.1.6Cross over Yes
    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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA107
    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
    Argentina
    Australia
    Brazil
    Canada
    Chile
    Israel
    Japan
    Mexico
    Peru
    Puerto Rico
    South Africa
    Turkey
    United States
    Austria
    Belgium
    Czechia
    France
    Germany
    Hungary
    Italy
    Poland
    United Kingdom
    Netherlands
    Romania
    Spain
    Switzerland
    E.8.7Trial has a data monitoring committee Yes
    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 the study will be the date of the last visit/contact/survival follow-up in the study.

    All Patients:
    The end of the entire study for all patients is defined as the date on which the last patient remaining on study completes the last study visit/call or when the sponsor decides to end the study. The sponsor reserves the right to terminate the study at any time for any reason (including safety).
    El fin del estudio será la fecha de la última visita/contacto/seguimiento de supervivencia en el estudio.

    Todos los pacientes:
    El final global del estudio para todos los pacientes se define como la fecha en que el último paciente que permanezca en el estudio complete la última visita/llamada o cuando el promotor decida finalizarlo. El promotor se reserva el derecho de finalizar el estudio en cualquier momento por cualquier razón (incluyendo seguridad)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days9
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months4
    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: 427
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 113
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 178
    F.4.2.2In the whole clinical trial 540
    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)
    At the end of study, in the event that the patient has not yet progressed on therapy, the sponsor will discuss options with the investigator to ensure the potential for continuing supply of SG, including the potential to receive treatment in a rollover study, if such a study is available to the patient.
    Cuando finalice el estudio, en el caso de que la enfermedad del paciente no haya progresado, el promotor discutirá las opciones disponibles con el investigador para asegurar el suministro continuado de SG incluyendo recibirlo potencialmente en un estudio de seguimiento si es que este está disponible para el paciente.
    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 Decision2022-07-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-10
    P. End of Trial
    P.End of Trial StatusOngoing
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