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    Summary
    EudraCT Number:2018-003969-33
    Sponsor's Protocol Code Number:IPH4102-201
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2019-07-04
    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 number2018-003969-33
    A.3Full title of the trial
    TELLOMAK: T-cell Lymphoma anti-KIR3DL2 therapy. An open label, multi-cohort, multi-center phase II study evaluating the efficacy and safety of IPH4102 alone or in combination with chemotherapy in patients with Advanced T-cell lymphoma.
    TELLOMAK: Tratamiento anti-KIR3DL2 para el linfoma de linfocitos T.
    Estudio en fase II, multicéntrico, abierto y de varias cohortes para evaluar la eficacia y la seguridad de IPH4102 solo o en combinación con quimioterapia en pacientes con linfoma de linfocitos T Avanzado.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of IPH4102 alone or in combination with chemotherapy in patients with Advanced T-cell Lymphoma.
    Estudio de IPH4102 solo o en combinación con quimioterapia en pacientes con linfoma de linfocitos T Avanzado.
    A.3.2Name or abbreviated title of the trial where available
    TELLOMAK
    TELLOMAK
    A.4.1Sponsor's protocol code numberIPH4102-201
    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 SponsorInnate Pharma SA
    B.1.3.4CountryFrance
    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 supportInnate Pharma
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationINNATE PHARMA
    B.5.2Functional name of contact pointMedical Director
    B.5.3 Address:
    B.5.3.1Street Address117, avenue de Luminy - BP30191
    B.5.3.2Town/ cityMarseille Cedex 09
    B.5.3.3Post code13276
    B.5.3.4CountryFrance
    B.5.4Telephone number+330430 30 30 30
    B.5.5Fax number+330430 30 30 10
    B.5.6E-mailinfo@innate-pharma.fr
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/14/1322
    D.3 Description of the IMP
    D.3.1Product nameIPH4102
    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 INNNone
    D.3.9.1CAS number 2187368-16-5
    D.3.9.3Other descriptive nameIPH4102
    D.3.9.4EV Substance CodeSUB176312
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeHumanised IgG1 monoclonal antibody
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Oxaliplatin 5 mg/ml concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi Oncology Plc
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameOxaliplatin 5 mg/ml concentrate for solution for infusion
    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 INNOXALIPLATIN
    D.3.9.1CAS number 61825-94-3
    D.3.9.4EV Substance CodeSUB09490MIG
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Gemcitabine 38 mg/ml concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi Oncology Plc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGemcitabine 38 mg/ml concentrate for solution for infusion
    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.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Advanced T-Cell Lymphomas (TCL), i.e. Cutaneous T Cell Lymphomas (CTCL) and Peripheral T Cell Lympomas (PTCL).
    CTCL subtypes under investigation: relapsed/refractory Sézary Syndrome (SS), stage IB to IV Mycosis Fungoides (MF).
    Relapsed/refractory PTCL subtypes under investigation: PTCL-Not Otherwise Specified (PTCL-NOS), AngioImmunoblastic T-cell Lymphoma
    (AITL), Anaplastic Large Cell Lymphoma (ALCL).
    Linfoma de linfocitos T avanzado con subtipos: linfoma cutáneo de linfocitos T (LCLT) y linfoma de linfocitos T periféricos (LLTP).
    Subtipos LCLT en investigación: Síndrome de Sézary recidivante/resistente (SS), micosis fungoide en estadío IB, IIA, IIB, III, IV (MF).
    Subtipos LLTP recidivante/resistente en investigación :LLTP sin especificar, linfoma angioinmunoblástico de linfocitos T (LAIT), linfoma anaplásico de células grandes (LACG).
    E.1.1.1Medical condition in easily understood language
    Rare types of cancers of the immune system
    Cánceres de tipo raro del sistema inmune
    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 HLT
    E.1.2Classification code 10034622
    E.1.2Term Peripheral T-cell lymphomas NEC
    E.1.2System Organ Class 100000004851
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10002450
    E.1.2Term Angioimmunoblastic T-cell lymphomas
    E.1.2System Organ Class 100000004851
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10002235
    E.1.2Term Anaplastic large cell lymphomas T- and null-cell types
    E.1.2System Organ Class 100000004851
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10028484
    E.1.2Term Mycoses fungoides
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the clinical activity of IPH4102 alone (Cohorts 1-3) or in combination with GEMOX chemotherapy (Cohorts 4 and 5) in patients with advanced T-cell lymphoma.
    Evaluar la tasa de respuesta objetiva (TRO) de IPH4102 en monoterapia (en las cohortes 1-3) o en combinación con quimioterapia con GEMOX (cohortes 4 y 5) en pacientes con linfoma de linfocitos T avanzado.
    E.2.2Secondary objectives of the trial
    -To characterize the safety and tolerability of IPH4102 alone (Cohorts 1-3) or in combination with GEMOX chemotherapy (Cohorts 4 and 5);
    -To further characterize the clinical activity of IPH4102 alone or in combination with GEMOX chemotherapy;
    -To evaluate the pharmacokinetics (PK) and immunogenicity of IPH4102 alone or in combination with GEMOX chemotherapy.
    -Caracterizar la seguridad y la tolerabilidad de IPH4102 en monoterapia (cohortes 1-3) o en combinación con quimioterapia con GEMOX (cohortes 4 y 5).
    -Evaluar otros criterios de valoración de la actividad clínica de IPH4102 en monoterapia o en combinación con quimioterapia con GEMOX.
    -Evaluar la farmacocinética (FC) y la inmunogenicidad de IPH4102 en monoterapia o en combinación con quimioterapia con GEMOX.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Cohort 1:
    1.Patients with relapsed/refractory SS who have received at least 2 prior systemic therapies;
    2.Prior treatment with mogamulizumab;
    3.Patients should have blood stage B2 at screening based on central evaluation by flow cytometry;
    4.Feasibility of obtaining at least 1 skin biopsy at screening.
    Cohorts 2 and 3:
    5.Patients with stage IB to IV MF;
    6.KIR3DL2 expression (Cohort 2) or non-expression (Cohort 3) in at least 1 skin lesion;
    7.Patients should have received at least 2 prior systemic therapies that may include biological agents;
    8.Feasibility of obtaining at least 1 skin biopsy at screening;
    9.Adequate baseline laboratory data: Hematology: CD4+ T-cells ≥200/µL.
    Cohorts 4 and 5:
    10.Patients with relapsed/refractory PTCL of the following subtypes: PTCL-NOS, angioimmunoblastic T-cell lymphoma (AITL), or anaplastic large cell lymphoma (ALCL);
    11.KIR3DL2 expression (Cohort 4) or non-expression (Cohort 5) based on 1 involved lymph node;
    12.Patients should have received at least 1 prior systemic therapy including an anthracycline-based chemotherapy. Patients who are not eligible for treatment with anthracycline based therapy are eligible for inclusion provided that they were treated with at least one prior systemic therapy;
    13.Presence of at least 1 target lesion on PET/CT scan at screening;
    14.Feasibility of obtaining 1 lymph node biopsy at screening.
    All cohorts:
    15.Male or Female, at least 18 years of age;
    16.ECOG performance status ≤2;
    17.The patient must have a minimum wash-out period of 4 weeks between the last dose of prior systemic therapy (8 weeks for biological agents) and the first dose of IPH4102
    18.Patients should have recovered from all adverse events related to prior therapy to ≤ grade 1;
    19.Adequate baseline laboratory data
    20.Women of childbearing potential (WOCBP) must have a negative serum beta-HCG pregnancy test result within seven days from start of treatment;
    21.Women of childbearing potential and all men (and their female partners of childbearing potential) who are sexually active must agree to use adequate method of contraception at study entry, during treatment and for at least 9 months (270 days) following the last dose of study drug.
    Cohorte 1:
    1.SS recidivante/resistente que hayan recibido al menos dos tratamientos sistémicos previos;
    2.Tratamiento previo con mogamulizumab;
    3.Los pacientes deberán presentar estadio B2 de la sangre determinado en la selección basándose en la evaluación central mediante citometría de flujo;
    4.Posibilidad de obtener al menos una biopsia cutánea en la selección.
    Cohortes 2 y 3:
    5.MF en Estadio IB, IIA, IIB, III, IV;
    6.Expresión de KIR3DL2 (cohorte 2) o no expresión (cohorte 3) en al menos una lesión cutánea.
    7.Los pacientes deben haber recibido al menos dos tratamientos sistémicos previos que pueden incluir fármacos biológicos;
    8.Posibilidad de obtener al menos una biopsia cutánea en la selección.
    9.Datos analíticos basales suficientes: Hematología: Linfocitos T CD4+ ≥ 200/µl.
    Cohortes 4 and 5:
    10.LLTP recidivante/resistente de los siguientes subtipos: LLTP sin especificar, linfoma angioinmunoblástico de linfocitos T (LAIT) o linfoma anaplásico de células grandes (LACG);
    11.Expresión de KIR3DL2 (cohorte 4) o no expresión (cohorte 5) basada en la evaluación de un ganglio linfático afectado;
    12.Las pacientes deben haber recibido al menos un tratamiento sistémico previo con quimioterapia con antraciclinas. Los pacientes que no sean aptos para recibir tratamiento con antraciclinas serán aptos para su inclusión siempre que hayan recibido al menos un tratamiento sistémico previo;
    13.Presencia de al menos una lesión diana en la PET/TAC en la selección.
    14.Posibilidad de obtener una biopsia ganglionar en la selección.
    Todas las cohortes:
    15.Varón o mujer de al menos 18 años de edad.
    16.Escala ECOG de Estado funcional ≤ 2.
    17.El paciente debe tener un período de lavado mínimo de 4 semanas entre la última dosis del tratamiento sistémico previo (8 semanas para los fármacos biológicos) y la primera dosis de IPH4102.
    18.Los pacientes deben haberse recuperado de todos los acontecimientos adversos relacionados con el tratamiento previo a grado ≤ 1.
    19.Datos analíticos basales suficientes.
    20.Las mujeres en edad fértil (MEF) deberán dar un resultado negativo en una prueba de embarazo de beta-HCG en suero realizada en los siete días previos al inicio del tratamiento.
    21.Las mujeres en edad fértil y todos los varones (y sus parejas femeninas en edad fértil) sexualmente activos deberán comprometerse a utilizar un método anticonceptivo adecuado en el momento de incorporarse al estudio, durante el tratamiento y durante al menos 9 meses (270 días) después de la última dosis del fármaco del estudio.
    E.4Principal exclusion criteria
    Cohorts 1 to 3:
    1.Patients with evidence of large cell transformation (LCT) based on central histologic evaluation.
    Cohorts 4 and 5:
    2.Prior administration of gemcitabine and/or oxaliplatin;
    3.Presence of grade 2 neurotoxicity or higher.
    All Cohorts:
    4.Known central nervous system (CNS) lymphoma;
    5.Prior administration of IPH4102;
    6.Concomitant administration of radiotherapy or systemic anti-cancer therapy including but not restricted to: chemotherapy, biological agents or immunotherapy;
    7.Autologous stem cell transplantation less than 3 months prior to enrollment;
    8.Prior allogenic transplantation;
    9.Concomitant corticosteroid use, systemic or topical. However, stable dosage of topical steroids (maximum strength Class III according to World Health Organization (WHO) Classification of Topical Corticosteroids) and/or systemic steroids (≤10 mg prednisone equivalent/day) are allowed, if patient has been on a stable dose for at least 4 weeks prior to treatment start;
    10.Patients who have undergone major surgery ≤ 4 weeks prior to study entry;
    11.Patients with known NCI CTCAE grade 3 or higher active systemic or cutaneous viral, bacterial, or fungal infection;
    12.Patients who have active Hepatitis B or C virus infection;
    13.Patients who are known to be HIV-positive;
    14.Patients with a history of other malignancies during the past 5 years apart from the disease subject of this study. The following are exempt from the five-year limit: non-melanoma skin cancer, lymphomatoid papulosis, resected thyroid cancer, biopsy-proven cervical intraepithelial neoplasia or cervical carcinoma in situ;
    15.Pregnant or breastfeeding women;
    16.Patients with congestive heart failure, Class III or IV, by New York Heart Association (NYHA) criteria;
    17.Patients with known active autoimmune disease;
    18.Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment and/or comply with study protocol;
    19.Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent document.
    Cohortes 1 a 3:
    1.Pacientes con signos de transformación de células grandes (TCL) según la evaluación histológica central.
    Cohortes 4 y 5:
    2.Administración previa de gemcitabina y/u oxaliplatino.
    3.Presencia de neurotoxicidad de grado 2 o superior.
    Todas las cohortes:
    4.Linfoma del sistema nervioso central (SNC) conocido.
    5.Administración previa de IPH4102.
    6.Administración concomitante de radioterapia o tratamiento antineoplásico sistémico, entre otros: quimioterapia, fármacos biológicos o inmunoterapia.
    7.Autotrasplante de células madre menos de 3 meses antes de la inclusión.
    8.Alotrasplante previo.
    9.Uso concomitante de corticosteroides, sistémicos o tópicos. Sin embargo, se permite una dosis estable de corticosteroides tópicos ( con una potencia máxima de III según la clasificación de los corticosteroides tópicos de la Organización Mundial de la Salud [OMS]) o corticosteroides sistémicos (≤ 10 mg de equivalente de prednisona/día), si el paciente ha recibido una dosis estable durante al menos 4 semanas antes del inicio del tratamiento.
    10.Pacientes sometidos a cirugía mayor ≤ 4 semanas antes de la entrada en el estudio.
    11.Pacientes con infección vírica, bacteriana o micótica sistémica o cutánea activa y conocida de grado 3 o superior según los CTCAE del NCI.
    12.Pacientes con infección activa por el virus de la hepatitis B o C.
    13.Pacientes que se sabe que son seropositivos para el VIH.
    14.Pacientes con antecedentes de otras neoplasias malignas en los últimos cinco años, aparte de la enfermedad objeto de este estudio. Los siguientes están exentos del límite de cinco años: cáncer de piel distinto del melanoma, papulosis linfomatoide, cáncer de tiroides resecado, neoplasia intraepitelial cervicouterina confirmada mediante biopsia o carcinoma in situ del cuello uterino;
    15.Mujeres embarazadas o en período de lactancia.
    16.Pacientes con insuficiencia cardíaca congestiva de clase III o IV según los criterios de la New York Heart Association (NYHA).
    17.Pacientes con enfermedad autoinmunitaria activa conocida;
    18.Pacientes con cualquier trastorno médico subyacente grave que altere su capacidad para recibir o tolerar el tratamiento previsto o cumplir el protocolo del estudio.
    19.Pacientes con demencia o alteración del estado mental que impida entender y otorgar el documento de consentimiento informado.
    E.5 End points
    E.5.1Primary end point(s)
    Objective Response Rate (ORR)
    Tasa de respuesta objetiva (TRO)
    E.5.1.1Timepoint(s) of evaluation of this end point
    ORR: until End of treatment (EOT) and during Follow-Up (FU) if applicable as per Protocol.
    TRO: hasta Final del tratamiento (FDT) y durante el Seguimiento (SEG) conforme al protocolo.
    E.5.2Secondary end point(s)
    Quality of life (QoL) (Cohorts 1-3), ORR using blinded central review (Cohort 1), duration of response (DOR), ORR lasting at least 4 months (ORR4) (Cohorts 1-3), progression free survival (PFS), overall survival (OS), minimal residual disease (MRD).
    Calidad de vida (CdV) (cohortes 1-3), TRO según una revisión central enmascarada (cohorte 1), duración de la respuesta,TRO de al menos 4 meses de duración (TRO4) (cohortes 1-3), supervivencia sin progresión (SSP), supervivencia global (SG), enfermedad residual mínima (ERM).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Until EOT and during FU if applicable.
    Hasta Final del tratamiento (FDT) y durante el Seguimiento (SEG) si aplica.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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
    France
    Germany
    Italy
    Spain
    United Kingdom
    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
    Last visit of the last subject
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 125
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 125
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 250
    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)
    Patients to be treated as per routine practice.
    Los pacientes recibirán su tratamiento de acuerdo con la práctica habitual.
    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 Decision2019-09-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-23
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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