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    Summary
    EudraCT Number:2018-001006-28
    Sponsor's Protocol Code Number:20170770
    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:2019-11-07
    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 number2018-001006-28
    A.3Full title of the trial
    PROCLAIM: A Phase 3 Randomized Placebo-controlled Double-blind Study of Romiplostim for the Treatment of Chemotherapy-induced Thrombocytopenia in Patients Receiving Chemotherapy for Treatment of Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, or Breast Cancer
    PROCLAIM: Estudio de fase 3 aleatorizado, controlado con placebo y doble ciego de romiplostim para el tratamiento de la trombocitopenia inducida por quimioterapia en pacientes que reciben quimioterapia para el tratamiento del cáncer de pulmón no microcítico (CPNM), el cáncer de ovario o el cáncer de mama.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects with Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, or Breast Cancer
    Estudio de romiplostim en la trombocitopenia inducida por quimioterapia en sujetos adultos con cáncer de pulmón no microcítico (CPNM), cáncer de ovario o cáncer de mama.
    A.3.2Name or abbreviated title of the trial where available
    Study of Romiplostim for CIT in in Adult Subjects with NSCLC, Ovarian Cancer, or Breast Cancer
    Estudio de romiplostim en la TIQ en sujetos adultos con CPNM, cáncer de ovario o de mama.
    A.4.1Sponsor's protocol code number20170770
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03937154
    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 SponsorAmgen 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 supportAmgen Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen S.A.
    B.5.2Functional name of contact pointIHQ medical Info-Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressWTC Barcelona, Moll de Barcelona, s/n, Edifici Sud 7a planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08039
    B.5.3.4CountrySpain
    B.5.4Telephone number+34936001860
    B.5.6E-mailiCOM_Spain@amgen.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 Nplate
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V.
    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.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNROMIPLOSTIM
    D.3.9.1CAS number 267639-76-9
    D.3.9.3Other descriptive nameROMIPLOSTIM
    D.3.9.4EV Substance CodeSUB27756
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product 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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for solution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    non-small cell lung cancer (NSCLC), ovarian cancer, or breast cancer
    cáncer de pulmón no microcítico (CPNM), cáncer de ovario o cáncer de mama
    E.1.1.1Medical condition in easily understood language
    lung cancer, ovarian cancer, or breast cancer
    cáncer de pulmón, cáncer de ovario o 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 21.1
    E.1.2Level PT
    E.1.2Classification code 10029519
    E.1.2Term Non-small cell lung 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 21.1
    E.1.2Level PT
    E.1.2Classification code 10029522
    E.1.2Term Non-small cell lung 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 21.1
    E.1.2Level PT
    E.1.2Classification code 10059515
    E.1.2Term Non-small cell lung 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 21.1
    E.1.2Level PT
    E.1.2Classification code 10057529
    E.1.2Term Ovarian 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 21.1
    E.1.2Level PT
    E.1.2Classification code 10070907
    E.1.2Term Ovarian 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 21.1
    E.1.2Level PT
    E.1.2Classification code 10070908
    E.1.2Term Ovarian 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 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 20.1
    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 evaluate the efficacy of romiplostim for the treatment of CIT in patients receiving chemotherapy for the treatment of NSCLC, ovarian cancer, or breast cancer measured by the ability to administer on-time, full-dose chemotherapy
    Evaluar la eficacia de romiplostim para el tratamiento de la TIQ en pacientes que reciben quimioterapia para el tratamiento
    del CPNM, el cáncer de ovario o el cáncer de mama, determinada por la capacidad de administrar puntualmente la dosis completa de la quimioterapia.
    E.2.2Secondary objectives of the trial
    -to compare the treatment effect of romiplostim with that of placebo on the depth of platelet nadir
    -to compare the treatment effect of romiplostim with that of placebo on the time to first platelet response
    -to compare the treatment effect of romiplostim with that of placebo on the incidence of > grade 2 bleeding events
    -to compare the treatment effect of romiplostim with that of placebo on overall survival
    -to compare the treatment effect of romiplostim with that of placebo on the incidence of platelet transfusions
    -to compare the treatment effect of romiplostim with that of placebo on the proportion of patients achieving platelet response
    -overall safety of romiplostim
    - Comparar el efecto del tratamiento de romiplostim con el de placebo sobre la profundidad del nadir de plaquetas.
    - Comparar el efecto del tratamiento de romiplostim con el de placebo sobre el tiempo hasta la primera respuesta plaquetaria.
    - Comparar el efecto del tratamiento con romiplostim con el de placebo sobre la incidencia de los acontecimientos hemorrágicos de grado ≥ 2.
    - Comparar el efecto del tratamiento con romiplostim con el de placebo sobre la supervivencia global.
    - Comparar el efecto del tratamiento con romiplostim con el de placebo sobre la incidencia de transfusiones de plaquetas.
    - Comparar el efecto del tratamiento con romiplostim con el de placebo sobre la proporción de pacientes que alcanzan la respuesta plaquetaria.
    - La seguridad global de romiplostim.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject has provided informed consent prior to initiation of any study-specific activities/procedures or subject’s legally acceptable representative has provided informed consent prior to any study-specific activities/procedures being initiated when the subject has any kind of condition that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent.
    2. Males or females > 18 years of age at signing of the informed consent.
    3. Documented active stage III or IV locally advanced or metastatic NSCLC, breast cancer, or ovarian cancer, or any stage recurrent disease.
    •patients with documented locally advanced (stage III) NSCLC should not be amenable to definitive treatment with chemoradiation and/or surgery.
    4. Subjects must be receiving cancer treatment with 21- or 28-day cycles, using one of the following carboplatinum-based combination chemotherapy regimens: carboplatin/gemcitabine based, carboplatin/pemetrexed based, or carboplatin/taxane based (which includes either paclitaxel, nab-paclitaxel, or docetaxel). Use of combination regimens with one of the above carboplatinum-based regimens is permitted with (1) anti-angiogenic agents (such as bevacizumab); (2) targeted therapy (such as anti-epidermal growth factor agents or anti- human epidermal growth factor receptor 2) or (3) immune checkpoint inhibitors. Cycle duration is based on intervals between day 1 of chemotherapy cycles (overlapping with carboplatin intervals) every 21 or 28 days.
    5. Subjects must have a platelet count < 75 x 109/L on day 1 of the study.
    6. Subjects must be at least 21 or 28 days removed from the start of the chemotherapy cycle immediately prior to study day 1 if receiving a 21-day or 28-day cycle chemotherapy regimen, respectively.
    7. Subjects must have at least 3 remaining planned cycles of chemotherapy at study enrollment.
    8. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
    1. El sujeto ha proporcionado su consentimiento informado antes de iniciar cualquier actividad/procedimiento específico del estudio o el representante legalmente aceptable del sujeto ha proporcionado el consentimiento informado antes de iniciar cualquier actividad/procedimiento específico del estudio en caso de que el sujeto padezca algún tipo de trastorno que, según el criterio del investigador, pueda comprometer su capacidad para proporcionar el
    consentimiento informado por escrito.
    2. Hombres o mujeres de edad ≥ 18 años en el momento de firmar el consentimiento informado.
    3. CPNM, cáncer de mama o cáncer de ovario activo documentado en estadio III o IV localmente avanzado o metastásico o enfermedad recurrente en cualquier estadio.
    • Los pacientes con CPNM localmente avanzado (estadio III) documentado no deberían ser susceptibles de tratamiento definitivo con radioterapia y/o cirugía.
    4. Los pacientes deben estar recibiendo un tratamiento antineoplásico en ciclos de 21 o 28 días con uno de los siguientes regímenes de quimioterapia en combinación basados en carboplatino: basado en carboplatino/gemcitabina,
    basado en carboplatino/pemetrexed o basado en carboplatino/taxano (que puede ser paclitaxel, nab-paclitaxel o docetaxel). Se permite el uso de los regímenes basados en carboplatino mencionados anteriormente en
    combinación con (1) agentes antiangiogénicos (como bevacizumab); (2) tratamiento dirigido (como los agentes dirigidos al factor de crecimiento epidérmico o al receptor 2 del factor de crecimiento epidérmico humano) o (3)
    inhibidores de los puntos de control inmunitarios. La duración del ciclo depende de los intervalos de 21 o 28 días con respecto al día 1 de los ciclos de quimioterapia (solapados con los intervalos de carboplatino).
    5. Los sujetos deben presentar un recuento plaquetario < 75 × 109/l el día 1 del estudio.
    6. Deben haber transcurrido al menos 21 o 28 días desde el inicio del ciclo de quimioterapia inmediatamente antes del día 1 del estudio, en función de si el sujeto recibe un régimen de quimioterapia en ciclos de 21 o 28 días,
    respectivamente.
    7. En el momento de la inclusión en el estudio, los sujetos deben tener pendientes al menos 3 ciclos de quimioterapia previstos.
    8. Estado funcional ECOG (Eastern Cooperative Oncology Group) de 0, 1 o 2.
    E.4Principal exclusion criteria
    1.Acute lymphoblastic leukemia.
    2.Acute myeloid leukemia.
    3.Any myeloid malignancy.
    4.Myelodysplastic syndrome. Baseline bone marrow biopsy is not required to rule out MDS. However, if a bone marrow biopsy and cytogenetics were performed as part of diagnostic or staging work-up, these results will be collected to confirm.
    5.Myeloproliferative disease.
    6.Multiple myeloma.
    7.Within 4 months prior to enrollment, any history of active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, uncontrolled arrhythmias, clinically significant electrocardiogram (ECG) abnormalities, screening ECG with corrected QT (QTc) interval of > 470 msec, pericardial disease, or myocardial infarction.
    8.Neo-adjuvant chemotherapy or adjuvant chemotherapy, which is offered as part of a multimodality treatment with surgery or definitive radiation
    9.Major surgery <28 days or minor surgery < 3 days prior to enrollment
    10.New or uncontrolled venous thromboembolism or thrombotic events within 3 months prior to screening.
    11.History of arterial thrombotic events (eg, myocardial ischemia, transient ischemic attack, or stroke) within 6 months prior to screening
    12.Evidence of active infection within 2 weeks prior to the first dose of study treatment
    13.Known human immunodeficiency virus infection.
    14. Known active of chronic hepatitis C or hepatitis B infection.
    15. In addition to the conditions listed in exclusion criteria 201 through 206, secondary malignancy within the past 5 years except:
    •Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
    •Adequately treated cervical carcinoma in situ without evidence of disease.
    •Adequately treated breast ductal carcinoma in situ without evidence of disease
    •Prostatic intraepithelial neoplasia without evidence of prostate cancer.
    •Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ.
    Malignancy treated with curative intent and with no known active disease present for >3 years before enrollment and felt to be at low risk for recurrence by the treating physician.
    16.Thrombocytopenia due to another etiology other than CIT
    17.Previous use of romiplostim, pegylated recombinant human megakaryocyte growth and development factor, eltrombopag, recombinant human TPO, any other TPO receptor agonist, or any investigational platelet producing agent.
    18.Currently receiving treatment in another investigational device or drug study, or less than 28 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
    19. Anemia (hemoglobin <8 g/dL) on the day of initiation of investigational product as assessed by local labs. Use of red cell transfusions and erythropoietic stimulating agents is permitted throughout the study as per institutional guidelines.
    20.Neutropenia (absolute neutrophil count <1 x 109/L) on the day of initiation of investigational product as assessed by local labs.
    21.Abnormal renal function with creatinine clearance <30 mL/min using the Cockcroft-Gault estimated creatinine clearance as assessed by central laboratory during screening.
    22. Abnormal liver function as assessed by central laboratory during screening.
    23. Females who are pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 7 months after treatment (and chemotherapy) discontinuation.
    24.Females of childbearing potential unwilling to use a highly effective method of contraception during treatment and for an additional 7 months after treatment(and chemotherapy) discontinuation.
    25. Males unwilling to use contraception* (male condom or sexual abstinence) or their female partner(s) of childbearing potential who are unwilling to use a highly effective method of contraception during treatment (and chemotherapy) and for an additional 7 months after treatment (and chemotherapy) discontinuation. *If the male’s sole partner is of non childbearing potential, he is not required to use additional forms of contraception during the study.
    26.Subject has known sensitivity to any of the products to be administered during dosing.
    27.Subject likely to not be available to complete/comply with all protocol-required study visits or procedures.
    28.History or evidence of any other clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
    29. Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment (and chemotherapy) and for
    an additional 7 months after treatment (and chemotherapy) discontinuation.
    30. Male subjects unwilling to abstain from donating sperm during treatment (and chemotherapy) and for an additional 7 months after treatment (and
    chemotherapy) discontinuation.
    1.Leucemia linfoblástica aguda
    2.Leucemia mieloide aguda
    3.Cualquier neoplasia maligna de estirpe mieloide
    4.Síndrome mielodisplásico.No es necesaria una biopsia de méd. ósea basal para descartar el SMD. Sin embargo si se realiza una biopsia de méd. ósea y un estud citogenético como parte del estudio diagnóstico o de estadificación,se recogerán estos resultados como confirm
    5.Enfermedad(enf)mieloproliferativa
    6.Mieloma múltiple
    7.Cualquier antecedente de insuficiencia cardíaca congestiva activa(de clase III a IV, según la NYHA),isquemia sintomática, arritmias no controladas, anomalías clínicamente significativas en el electrocardiograma (ECG),ECG de selec con un intervalo QT corregido>470ms, enf del pericardio o infarto de miocardio durante los 4meses previos a la inclusión
    8.Quimioterapia(QT)neoadyuvante o adyuvante ofrecida como parte del tratamiento(Trto) multimodal junto con cirugía o radioterapia definitiva
    9.Cirugía mayor ≤ 28d o cirugía menor ≤ 3d antes de la inclusión
    10.Tromboembolismo venoso o acontecimientos trombóticos nuevos o no controlados en los 3meses previos a la selec
    11.Antecedentes de acontecimientos trombóticos (isquemia miocárdica,accidente isquémico transitorio o ictus)en los 6m prev. a la selec
    12.Evidencia(evid) de infec activa en las 2sem previas a la primera dosis del Tr del estud
    13.Infec conocida por el virus de la inmunodeficiencia humana
    14.Infec conocida activa o crónica por hepatitisBoC
    15.Además de las enf enumeradas en los criterios de exclusión 1a6, neoplasias malignas secundarias en los últimos 5añ excepto:
    •Cáncer de piel no melanomatoso o lentigo maligno tratados adecuadamente sin evid de enf•Carcinoma insitu de cuello uterino tratado adecuadamente sin evid de enf•Carcinoma ductal insitu de mama tratado adecuadamente sin evid de enf•Neoplasia intraepitelial prostática sin evid de cáncer de próstata•Carcinoma urotelial papilar no invasivo o carcinoma insitu tratados adecuadamente•Tumor maligno tratado con intención curativa y sin presencia de enf activa confirmada durante≥3añ antes de la inclusión y que el médico responsable del Trto considere de bajo riesgo de recurrencia
    16.Trombocitopenia por causas distintas a las de la TIQ
    17.Uso previo de romiplostim, factor de crecimiento y desarrollo de megacariocito humano recomb. pegilado, eltrombopag, TPO humana recomb., cualquier otro agonista de los receptores de TPO o cualquier agente productor
    18.Estar recibiendo actualmente Trto en otro estud de un fármaco o producto sanitario en invest o que hayan transcurrido menos de 28d desde el fin del Trto en otro estud de un fármaco o producto sanitario en invest. Queda excluido cualquier otro procedimiento de invest durante la participación en este estud
    19.Anemia (hemoglobina<8g/dl) el día de inicio del producto en invest, determinada por lab. locales. Se permite el uso de transfusiones de hematíes y de agentes estimulantes de la eritropoyesis durante todo el estud,de conformidad con las guías
    20.Neutropenia (recuento absoluto de neutrófilos<1x109/l) el día de inicio del producto en invest, determinada por lab. locales
    21.Alteración de la función renal con un aclaramiento de creatinina<30ml/min según la estimación de Cockcroft-Gault, determinada por el lab. central durante la selec
    22.Alteración de la función hepática determinada por el lab. central durante la selec.
    23.Mujeres embarazadas o que den el pecho o que planeen quedarse embarazadas o dar el pecho durante el Trto y durante los 7m posteriores a la interrupción delTrto(y la QT)
    24.Mujeres en edad fértil no dispuestas a utilizar un método anticonceptivo altamente eficaz durante el Trto y durante los 7m posteriores a la interrupción delTrto(y la QT)
    25.Hombres no dispuestos a utilizar un método anticonceptivo (preservativo masculino o abstinencia sexual) o cuya pareja sea una mujer en edad fértil no dispuesta a utilizar un método anticonceptivo altamente eficaz durante el Trto(y la QT) y durante los 7m posteriores a la interrupción del Trto(y la QT)*si su única pareja es una mujer estéril, no es necesario utilizar otros métodos anticonceptivos durante elestud
    26.El sujeto presenta una sensibilidad conocida a alguno de los productos que se administrarán durante la dosificación
    27.Según informan el sujeto y el investigador, es posible que el sujeto no esté disponible para completar todas las visitas o procedimientos del estud requeridos por el protocolo
    28.Antecedentes o evid de cualquier otro trastorno, condición o enf clínicamente significativos que pudieran suponer un riesgo para la seguridad del sujeto o interferir en la evaluación, los procedimientos o la realización del estud
    29.Hombres con pareja embarazada no dispuestos a abstenerse o utilizar preservativo durante el Trto(y la QT) y durante los 7m posteriores a la interrupción delTrto(y la QT)
    30.Hombres no dispuestos a abstenerse de donar esperma durante el Trto(y la QT) y durante los 7m posteriores a la interrupción delTrto(y la QT)
    E.5 End points
    E.5.1Primary end point(s)
    no thrombocytopenia-induced modification of any myelosuppressive agent in the second and third cycles of the planned on-study chemotherapy regimen. Thrombocytopenia-induced
    modifications include chemotherapy dose reduction, delay, omission, or chemotherapy treatment discontinuation due to platelet counts below 100 x 109/L.
    Ausencia de modificación inducida por la trombocitopenia de cualquier agente
    mielosupresor en los ciclos segundo y tercero del régimen de quimioterapia previsto en el estudio. Las modificaciones
    inducidas por trombocitopenia incluyen la reducción, el retraso y la omisión de la dosis de quimioterapia o la interrupción del tratamiento con quimioterapia debido a recuentos plaquetarios inferiores a 100 x 109/l.
    E.5.1.1Timepoint(s) of evaluation of this end point
    -The primary analysis will be performed at the primary completion date. The primary completion date is defined as the date when the last subject is assessed or receives an intervention for the final collection of data for the primary endpoint for the purposes of conducting the primary analysis, whether the study concluded as planned in the protocol or was terminated early.
    -el análisis primario se realizará en la fecha de finalización primaria. La fecha de finalización primaria se define como la fecha en la que los sujetos son evaluados o se someten a la última intervención para la recogida de datos necesarios para los endpoints primarios y así llevar a cabo los análisis primarios , tanto cuando el estudio finaliza según lo planificado en el protocolo como cuando termina prematuramente
    E.5.2Secondary end point(s)
    - the depth of the platelet count nadir from the start of the first on-study chemotherapy cycle through the end of the treatment period
    -the time to first platelet response, defined by platelet count 100 x 109/L in the absence of platelet transfusions during the preceding 7 days
    -the duration-adjusted event rate of grade 2 bleeding events, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grading scale
    -overall survival
    -platelet transfusion(s) during the treatment period
    -achieving a platelet count 100 x 109/L at any time after study day 1 to week 4 (i.e. 7 days after the planned third dose of investigational product) and in the absence of platelet transfusions during the preceding 7 days
    -adverse events, including treatment-emergent adverse events, fatal
    adverse events, serious adverse events,and clinically significant changes in laboratory values
    -anti-romiplostim antibodies and antibodies to thrombopoietin (TPO)
    -myelodysplastic syndromes and secondary malignancies
    -La profundidad del nadir del recuento de plaquetas desde el inicio del primer ciclo de
    quimioterapia durante el estudio hasta el final del período de tratamiento.
    -El tiempo hasta la primera respuesta plaquetaria, definido por un recuento plaquetario de ≥ 100 x 109/l en ausencia de
    transfusiones de plaquetas durante los 7 días previos.
    -La tasa de acontecimientos ajustados por duración de acontecimientos hemorrágicos de grado ≥ 2, evaluados mediante la escala de clasificación de los criterios terminológicos comunes de acontecimientos adversos (CTCAE), versión 5.0.
    -La supervivencia global.
    -Transfusión/es de plaquetas durante el periodo de tratamiento.
    -Alcanzar un recuento plaquetario de ≥ 100 x 109/l en cualquier momento después del día 1 del estudio hasta la
    semana 4 (es decir, 7 días después de la tercera dosis prevista del producto en investigación) y en ausencia de transfusión de plaquetas durante los 7 días anteriores Acontecimientos adversos, incluidos acontecimientos adversos aparecidos durante el tratamiento, acontecimientos adversos mortales, acontecimientos adversos graves y cambios clínicamente significativos en los valores de laboratorio.
    - Anticuerpos antiromiplostim y anticuerpos frente a la trombopoyetina (TPO).
    - Síndromes mielodisplásicos y tumores malignos secundarios.
    E.5.2.1Timepoint(s) of evaluation of this end point
    -The primary analysis will be performed at the primary completion date. The primary completion date is defined as the date when the last subject is assessed or receives an intervention for the final collection of data for the primary endpoint.

    -When the last subject in the trial completes LTFU at 1 year after the last dose of investigational product, the final database will be locked for the final analysis. In the final analysis, the secondary endpoints assessment, and all the exploratory endpoints will be evaluated
    -el análisis primario se realizará en la fecha de finalización primaria. La fecha de finalización primaria se define como la fecha en la que los sujetos son evaluados o se someten a la última intervención para la recogida de datos necesarios para los endpoint primario.

    -Cuando el ultimo paciente del estudio completa el seguimiento a largo plazo (LTFU) 1 año después de la última dosis del producto en investigación, la base de datos final se bloqueará para el análisis final. En el análisis final, se evaluaran los endpoints secundarios y los endpoints exploratorios.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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 concerned4
    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
    Argentina
    Austria
    Brazil
    Bulgaria
    Canada
    Chile
    Colombia
    Greece
    Hungary
    Mexico
    Peru
    Poland
    Portugal
    Romania
    Russian Federation
    Spain
    Ukraine
    United States
    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 study (EOS) date is defined as the date when the last subject across all sites is assessed or receives an intervention for evaluation in the study (i.e. last subject last visit), following any additional parts in the study (eg, LTFU), as applicable. Based on the definition above, the EOS date is the date when the last subject in the trial has completed his/her EOS visit.
    la fecha de fin de ensayo se define como la fecha de la ultima evaluación o intervención del ultimo paciente del ultimo centro del estudio (p.ej. ultimo paciente ultima visita), siguiendo con cualquier parte adicional del estudio (p.ej. seguimiento a largo plazo [LTFU]) segun corresponda. en base a la definición anterior, la fecha de fin de ensayo es la fecha en la que el ultimo paciente del estudio finaliza su visita de fin de ensayo.
    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 days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    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: 108
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 54
    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 No
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 61
    F.4.2.2In the whole clinical trial 162
    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)
    N/A
    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 Decision2019-11-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-03
    P. End of Trial
    P.End of Trial StatusOngoing
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