A Study of Atezolizumab in Advanced Solid Tumors
11 de mayo de 2021 actualizado por: Hoffmann-La Roche
An Open-Label, Multicohort, Phase II Study of Atezolizumab in Advanced Solid Tumors
The primary efficacy objective for this study is to evaluate non-progression rate (NPR) at 18 weeks in participants with advanced solid tumors treated with atezolizumab, defined as the percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1, or according to disease-specific criteria for prostate cancer and malignant pleural mesothelioma.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
474
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Hamburg, Alemania, 20246
- Uniklinik-Eppendorf; Zentren F. Innere Medizin-Klinik U. Poliklinik
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Heidelberg, Alemania, 69120
- Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen
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Trier, Alemania, 54290
- Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie
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Graz, Austria, 8036
- LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie
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Wien, Austria, 1090
- Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Chemotherapie & Infektionskrankhei
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RJ
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Rio de Janeiro, RJ, Brasil, 20231-050
- INCA 1- Instituto Nacional de Câncer X
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RS
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Porto Alegre, RS, Brasil, 90035-903
- Hospital das Clinicas - UFRGS
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SP
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Sao Paulo, SP, Brasil, 01246-000
- Instituto do Cancer do Estado de Sao Paulo - ICESP
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British Columbia
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Vancouver, British Columbia, Canadá, V5Z 4E6
- BCCA-Vancouver Cancer Centre
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Ontario
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Toronto, Ontario, Canadá, M5G 2M9
- University Health Network; Princess Margaret Hospital; Medical Oncology Dept
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Aarhus N, Dinamarca, 8200
- Aarhus Universitetshospital; Kræftafdelingen
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Herlev, Dinamarca, 2730
- Herlev Hospital; Afdeling for Kræftbehandling
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Odense C, Dinamarca, 5000
- Odense Universitetshospital, Onkologisk Afdeling, Klinisk Forsknings Enhed
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Barcelona, España, 08035
- Hospital Univ Vall d'Hebron; Servicio de Oncologia
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Navarra
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Pamplona, Navarra, España, 31008
- Clinica Universitaria de Navarra; Servicio de Oncologia
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New York
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New York, New York, Estados Unidos, 10027
- Columbia University Medical Center
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New York, New York, Estados Unidos, 10065
- Memorial Sloan Kettering
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Ohio
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Cleveland, Ohio, Estados Unidos, 44195
- The Cleveland Clinic Foundation
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37203
- Sarah Cannon Cancer Center and Research Institute
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Texas
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Houston, Texas, Estados Unidos, 77030
- MD Anderson Cancer Center
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Moscow, Federación Rusa, 115478
- Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy
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Saint-Petersburg, Federación Rusa, 197758
- S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
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Helsinki, Finlandia, 00029
- Helsinki University Central Hospital; Dept of Oncology
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Bordeaux, Francia, 33076
- Institut Bergonie
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Lyon, Francia, 69373
- Centre Leon Berard; Departement Oncologie Medicale
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Paris, Francia, 75475
- Hopital Saint Louis, Service D Oncologie Medicale
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Villejuif, Francia, 94805
- Institut Gustave Roussy
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Dublin, Irlanda, 4
- St Vincent'S Uni Hospital; Medical Oncology
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Dublin, Irlanda
- St James' Hospital; Cancer Clinical Trials Office
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Campania
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Napoli, Campania, Italia, 80131
- Istituto Nazionale Tumori Fondazione G. Pascale
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Lombardia
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Milano, Lombardia, Italia, 20133
- Fondazione IRCCS Istituto Nazionale dei Tumori
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Toscana
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Siena, Toscana, Italia, 53100
- Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica
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Bergen, Noruega, 5021
- Haukeland Universitetssjukehus; Klinisk forskningspost
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Oslo, Noruega, 0310
- Oslo Universitetssykehus HF; Radiumhospitalet
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Edirne, Pavo, 22030
- Trakya University Medical Faculty
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Istanbul, Pavo, 34300
- Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
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Istanbul, Pavo, 34384
- Prof. Dr. Cemil Tascioglu City Hospital; Med Onc
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Sihhiye/Ankara, Pavo, 06230
- Hacettepe Uni Medical Faculty Hospital; Oncology Dept
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Amsterdam, Países Bajos, 1066 CX
- Antoni van Leeuwenhoek Ziekenhuis
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Rotterdam, Países Bajos, 3015 GD
- Erasmus MC
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Utrecht, Países Bajos, 3584 CX
- Universitair Medisch Centrum Utrecht
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Bydgoszcz, Polonia, 85-796
- Centrum Onkologii w Bydgoszczy
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Gdańsk, Polonia, 80-214
- Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
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Warszawa, Polonia, 02-781
- Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie; Klinika Now. Tkanek Miekkich,Kosci i Czer.
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Bebington, Reino Unido, CH63 4JY
- Clatterbridge Cancer Centre
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Southampton, Reino Unido, SO16 6YD
- Southampton General Hospital; Medical Oncology
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Fribourg, Suiza, 1708
- Freiburger Spital; Onkologie
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St. Gallen, Suiza, 9007
- Kantonsspital St. Gallen; Onkologie/Hämatologie
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Histologically documented advanced solid tumors that meet protocol-defined cohort specifications, have progressive disease at study entry, and have received at least one line of prior systemic therapy or for which no alternative therapy to prolong survival exists
- Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (preferred) or in freshly cut and unstained slides (exceptional cases) with an associated pathology report for central testing
- Measurable disease as defined by RECIST v1.1 or disease-specific criteria for prostate cancer and malignant pleural mesothelioma
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Negative serum pregnancy test result within 14 days prior to study drug among women of childbearing potential
- Life expectancy > 3 months
Exclusion Criteria:
- Malignancies other than disease under study within 5 years prior to Day 1 of Cycle 1 except those with a negligible risk of metastasis or death
- Uncontrolled tumor-related pain
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures >/=1 time per month
- History of asymptomatic or symptomatic central nervous system (CNS) metastasis
- Leptomeningeal disease
- Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated but without evidence that disease has been clinically stable for >/=2 weeks prior to Day 1 of Cycle 1
- Pregnant and lactating women
- Significant cardiovascular disease within 3 months prior to Day 1 of Cycle 1
- Severe infection within 4 weeks prior to Day 1 of Cycle 1
- Oral or IV antibiotics within 2 weeks prior to Day 1 of Cycle 1
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or to any component of the atezolizumab formulation
- History of autoimmune disease except treated/stable hypothyroidism, Type 1 diabetes mellitus, and protocol-specified dermatologic conditions
- Active tuberculosis
- Signs or symptoms of infection within 2 weeks prior to Day 1 of Cycle 1
- Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, or anti-programmed cell death-1 (PD-1) or anti-PD-L1 therapeutic antibodies
- Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to Day 1 of Cycle 1, or anticipated requirement for systemic immunosuppressive medications during the trial
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Atezolizumab
The dose of atezolizumab in this study will be 1200 milligrams (mg) administered by intravenous (IV) infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity.
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Atezolizumab will be given as IV infusion over 60 minutes on Day 1 of Cycle 1, then over 30 minutes (as tolerated) on Day 1 of each subsequent 3-week cycle.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Non-progression Rate (NPR) at 18 Weeks
Periodo de tiempo: At Week 18
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NPR was defined as the percentage of participants with complete response (CR), partial response (PR) or stable disease (SD) as assessed by the Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST), v1.1 or for malignant pleural mesothelioma according to Malignant Pleural Mesothelioma Response Evaluation Criteria.
CR: Disappearance of all target lesions.
PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions in the absence of CR.
SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).
PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions.
For prostate cancer according to Prostate Response Evaluation Criteria.
CR: PSA <5 ng/ml measured twice at least 3 weeks apart or PSA response: PSA < 50% of the PSA reference value occurring at any time after treatment was initiated.
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At Week 18
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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NPR at 24 Weeks
Periodo de tiempo: At Week 24
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NPR was defined as the percentage of participants with complete response (CR), partial response (PR) or stable disease (SD) as assessed by the Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST), v1.1 or for malignant pleural mesothelioma according to Malignant Pleural Mesothelioma Response Evaluation Criteria.
CR: Disappearance of all target lesions.
PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions in the absence of CR.
SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).
PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions.
For prostate cancer according to Prostate Response Evaluation Criteria.
CR: PSA <5 ng/ml measured twice at least 3 weeks apart or PSA response: PSA < 50% of the PSA reference value occurring at any time after treatment was initiated.
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At Week 24
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Overall Response Rate (ORR)
Periodo de tiempo: Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)
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ORR was defined as the percentage of participants with CR or PR as assessed by the investigator using RECIST v1.1 or Malignant Pleural Mesothelioma Response Evaluation Criteria.
CR: Disappearance of all target lesions.
PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR.
For prostate cancer according to Prostate Response Evaluation Criteria.
CR: PSA <5 ng/ml measured twice at least 3 weeks apart or PSA response: PSA < 50% of the PSA reference value occurring at any time after treatment was initiated.
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Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)
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Percentage of Participants by Best Overall Response (BOR)
Periodo de tiempo: Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)
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BOR was based on RECIST v1.1, Malignant Pleural Mesothelioma Response Evaluation Criteria or Prostate Response Evaluation Criteria.
For an individual participant BOR was obtained as follows: 1) CR: overall tumor response assessment of CR at 2 consecutive visits at least 28 days apart.
2) PR: overall tumor response assessment of PR or CR at 2 consecutive visits at least 28 days apart without being a CR. 3) SD: overall tumor response assessment of SD, PR, or CR at one or more visits at least 42 days after start of study treatment, but was not a confirmed CR or PR. 4) PD: an overall tumor response assessment of PD at any visit, and did not meet the criteria for a BOR of CR, PR or SD. 5) Missing: an assessment of SD, PR or CR in the first 42 days after start of study treatment and no further tumor assessments thereafter.
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Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)
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Clinical Benefit Rate (CBR)
Periodo de tiempo: Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)
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CBR was defined as the percentage of participants with CR, PR, or SD according to RECIST v1.1, Malignant Pleural Mesothelioma Response Evaluation Criteria or Prostate Response Evaluation Criteria lasting for >/=6 weeks.
CR: Disappearance of all target lesions.
PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions in the absence of CR.
SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).
PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions.
For prostate cancer: CR: PSA <5 ng/ml measured twice at least 3 weeks apart or PSA response: PSA < 50% of the PSA reference value occurring at any time after treatment was initiated.
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Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)
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Duration of Objective Response (DOR)
Periodo de tiempo: Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)
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DOR, based on RECIST v1.1, was defined as the time from the first occurrence of a documented objective response (CR or PR) to the time of progression or death from any cause, whichever occurred first.
CR: Disappearance of all target lesions.
PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions in the absence of CR.
PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions.
As pre-specified in the Statistical Analysis Plan (SAP) DOR was not analyzed if there were less than 4 participants available for the analysis.
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Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)
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Progression-Free Survival (PFS)
Periodo de tiempo: Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)
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PFS, based on RECIST v1.1, was defined as the time from the first day of study treatment to the first occurrence of disease progression or death from any cause, whichever occurred first.
PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions.
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Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)
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Time to Progression (TTP)
Periodo de tiempo: Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)
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Time to progression (TTP), based on RECIST v1.1, was defined as time from the first day of study treatment to the first occurrence of progressive disease or death due to disease progression, whichever occurred first.
PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions.
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Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)
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Overall Survival (OS)
Periodo de tiempo: Baseline until death due to any cause (up to 4.5 years)
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OS was defined as the time from the first day of study treatment to death from any cause.
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Baseline until death due to any cause (up to 4.5 years)
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Number of Participants With Adverse Events
Periodo de tiempo: Baseline up to 4.5 years
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An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment.
An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.
Preexisting conditions which worsen during a study are also considered as adverse events.
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Baseline up to 4.5 years
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Treatment Duration of Atezolizumab
Periodo de tiempo: Baseline up to approximately 4.5 years
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Baseline up to approximately 4.5 years
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Mean Number of Doses of Atezolizumab
Periodo de tiempo: Baseline up to approximately 4.5 years
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Baseline up to approximately 4.5 years
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Percentage of Participants With Anti-drug Antibodies (ADAs) to Atezolizumab
Periodo de tiempo: Baseline up to 4.5 years
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Baseline up to 4.5 years
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Serum Concentration of Atezolizumab
Periodo de tiempo: Predose and postdose on Day 1 of Cycle 1, predose on Day 1 of Cycles 2, 3, 4, 8 (cycle length = 21 days), and every 8 cycles until treatment discontinuation; at follow up (approximately 120 days after last dose) up to approximately 4.5 years
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Predose and postdose on Day 1 of Cycle 1, predose on Day 1 of Cycles 2, 3, 4, 8 (cycle length = 21 days), and every 8 cycles until treatment discontinuation; at follow up (approximately 120 days after last dose) up to approximately 4.5 years
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Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR)
Periodo de tiempo: Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)
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Modified RECIST was based on the following: 1) New measurable lesions were added into the total tumor burden and followed; 2) Non-target lesions contributed only in the assessment of a CR; 3) Radiographic progression was determined only on the basis of measurable disease; had to be confirmed by a consecutive assessment =/>4 weeks from the date first documented.
mBOR: 1) CR: overall tumor response assessment of CR at 2 consecutive visits at least 28 days apart.
2) PR: overall tumor response assessment of PR/CR at 2 consecutive visits at least 28 days apart without being a CR. 3) SD: overall tumor response assessment of SD/PR/CR at one or more visits at least 42 days after start of study treatment, but was not a confirmed CR or PR. 4) PD: an overall tumor response assessment of PD at any visit, and did not meet the criteria for a BOR of CR, PR or SD. 5) Missing: an assessment of SD, PR or CR in the first 42 days after start of study treatment and no further tumor assessments thereafter.
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Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)
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ORR Based on Modified RECIST v1.1
Periodo de tiempo: Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)
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Modified RECIST was based on the following: 1) New measurable lesions were added into the total tumor burden and followed; 2) Non-target lesions contributed only in the assessment of a CR; 3) Radiographic progression was determined only on the basis of measurable disease; had to be confirmed by a consecutive assessment =/>4 weeks from the date first documented.
ORR was defined as the percentage of participants with CR or PR.
CR: Disappearance of all target lesions.
PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR.
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Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)
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CBR Based on Modified RECIST v1.1
Periodo de tiempo: Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)
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Modified RECIST was based on the following: 1) New measurable lesions were added into the total tumor burden and followed; 2) Non-target lesions contributed only in the assessment of a CR; 3) Radiographic progression was determined only on the basis of measurable disease; had to be confirmed by a consecutive assessment =/>4 weeks from the date first documented.
CBR was defined as the percentage of participants with CR, PR, or SD lasting for >/=6 weeks.
CR: Disappearance of all target lesions.
PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions in the absence of CR.
SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).
PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions.
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Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
16 de julio de 2015
Finalización primaria (Actual)
4 de abril de 2018
Finalización del estudio (Actual)
28 de julio de 2020
Fechas de registro del estudio
Enviado por primera vez
28 de mayo de 2015
Primero enviado que cumplió con los criterios de control de calidad
28 de mayo de 2015
Publicado por primera vez (Estimar)
1 de junio de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de junio de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
11 de mayo de 2021
Última verificación
1 de mayo de 2021
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MO29518
- 2015-000269-30 (Número EudraCT)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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