A Study of Atezolizumab in Advanced Solid Tumors
11 мая 2021 г. обновлено: 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.
Обзор исследования
Статус
Завершенный
Условия
Тип исследования
Интервенционный
Регистрация (Действительный)
474
Фаза
- Фаза 2
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
-
-
-
Graz, Австрия, 8036
- LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie
-
Wien, Австрия, 1090
- Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Chemotherapie & Infektionskrankhei
-
-
-
-
RJ
-
Rio de Janeiro, RJ, Бразилия, 20231-050
- INCA 1- Instituto Nacional de Câncer X
-
-
RS
-
Porto Alegre, RS, Бразилия, 90035-903
- Hospital das Clinicas - UFRGS
-
-
SP
-
Sao Paulo, SP, Бразилия, 01246-000
- Instituto do Cancer do Estado de Sao Paulo - ICESP
-
-
-
-
-
Hamburg, Германия, 20246
- Uniklinik-Eppendorf; Zentren F. Innere Medizin-Klinik U. Poliklinik
-
Heidelberg, Германия, 69120
- Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen
-
Trier, Германия, 54290
- Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie
-
-
-
-
-
Aarhus N, Дания, 8200
- Aarhus Universitetshospital; Kræftafdelingen
-
Herlev, Дания, 2730
- Herlev Hospital; Afdeling for Kræftbehandling
-
Odense C, Дания, 5000
- Odense Universitetshospital, Onkologisk Afdeling, Klinisk Forsknings Enhed
-
-
-
-
-
Dublin, Ирландия, 4
- St Vincent'S Uni Hospital; Medical Oncology
-
Dublin, Ирландия
- St James' Hospital; Cancer Clinical Trials Office
-
-
-
-
-
Barcelona, Испания, 08035
- Hospital Univ Vall d'Hebron; Servicio de Oncologia
-
-
Navarra
-
Pamplona, Navarra, Испания, 31008
- Clinica Universitaria de Navarra; Servicio de Oncologia
-
-
-
-
Campania
-
Napoli, Campania, Италия, 80131
- Istituto Nazionale Tumori Fondazione G. Pascale
-
-
Lombardia
-
Milano, Lombardia, Италия, 20133
- Fondazione IRCCS Istituto Nazionale dei Tumori
-
-
Toscana
-
Siena, Toscana, Италия, 53100
- Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica
-
-
-
-
British Columbia
-
Vancouver, British Columbia, Канада, V5Z 4E6
- BCCA-Vancouver Cancer Centre
-
-
Ontario
-
Toronto, Ontario, Канада, M5G 2M9
- University Health Network; Princess Margaret Hospital; Medical Oncology Dept
-
-
-
-
-
Amsterdam, Нидерланды, 1066 CX
- Antoni van Leeuwenhoek Ziekenhuis
-
Rotterdam, Нидерланды, 3015 GD
- Erasmus MC
-
Utrecht, Нидерланды, 3584 CX
- Universitair Medisch Centrum Utrecht
-
-
-
-
-
Bergen, Норвегия, 5021
- Haukeland Universitetssjukehus; Klinisk forskningspost
-
Oslo, Норвегия, 0310
- Oslo Universitetssykehus HF; Radiumhospitalet
-
-
-
-
-
Bydgoszcz, Польша, 85-796
- Centrum Onkologii w Bydgoszczy
-
Gdańsk, Польша, 80-214
- Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
-
Warszawa, Польша, 02-781
- Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie; Klinika Now. Tkanek Miekkich,Kosci i Czer.
-
-
-
-
-
Moscow, Российская Федерация, 115478
- Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy
-
Saint-Petersburg, Российская Федерация, 197758
- S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
-
-
-
-
-
Bebington, Соединенное Королевство, CH63 4JY
- Clatterbridge Cancer Centre
-
Southampton, Соединенное Королевство, SO16 6YD
- Southampton General Hospital; Medical Oncology
-
-
-
-
New York
-
New York, New York, Соединенные Штаты, 10027
- Columbia University Medical Center
-
New York, New York, Соединенные Штаты, 10065
- Memorial Sloan Kettering
-
-
Ohio
-
Cleveland, Ohio, Соединенные Штаты, 44195
- The Cleveland Clinic Foundation
-
-
Tennessee
-
Nashville, Tennessee, Соединенные Штаты, 37203
- Sarah Cannon Cancer Center and Research Institute
-
-
Texas
-
Houston, Texas, Соединенные Штаты, 77030
- MD Anderson Cancer Center
-
-
-
-
-
Edirne, Турция, 22030
- Trakya University Medical Faculty
-
Istanbul, Турция, 34300
- Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
-
Istanbul, Турция, 34384
- Prof. Dr. Cemil Tascioglu City Hospital; Med Onc
-
Sihhiye/Ankara, Турция, 06230
- Hacettepe Uni Medical Faculty Hospital; Oncology Dept
-
-
-
-
-
Helsinki, Финляндия, 00029
- Helsinki University Central Hospital; Dept of Oncology
-
-
-
-
-
Bordeaux, Франция, 33076
- Institut Bergonie
-
Lyon, Франция, 69373
- Centre Leon Berard; Departement Oncologie Medicale
-
Paris, Франция, 75475
- Hopital Saint Louis, Service D Oncologie Medicale
-
Villejuif, Франция, 94805
- Institut Gustave Roussy
-
-
-
-
-
Fribourg, Швейцария, 1708
- Freiburger Spital; Onkologie
-
St. Gallen, Швейцария, 9007
- Kantonsspital St. Gallen; Onkologie/Hämatologie
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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.
|
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.
Другие имена:
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Non-progression Rate (NPR) at 18 Weeks
Временное ограничение: At Week 18
|
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.
|
At Week 18
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
NPR at 24 Weeks
Временное ограничение: At Week 24
|
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.
|
At Week 24
|
|
Overall Response Rate (ORR)
Временное ограничение: 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)
|
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.
|
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)
|
|
Percentage of Participants by Best Overall Response (BOR)
Временное ограничение: 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)
|
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.
|
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)
|
|
Clinical Benefit Rate (CBR)
Временное ограничение: 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)
|
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.
|
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)
|
|
Duration of Objective Response (DOR)
Временное ограничение: 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)
|
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.
|
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)
|
|
Progression-Free Survival (PFS)
Временное ограничение: 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)
|
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.
|
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)
|
|
Time to Progression (TTP)
Временное ограничение: 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)
|
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.
|
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)
|
|
Overall Survival (OS)
Временное ограничение: Baseline until death due to any cause (up to 4.5 years)
|
OS was defined as the time from the first day of study treatment to death from any cause.
|
Baseline until death due to any cause (up to 4.5 years)
|
|
Number of Participants With Adverse Events
Временное ограничение: Baseline up to 4.5 years
|
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.
|
Baseline up to 4.5 years
|
|
Treatment Duration of Atezolizumab
Временное ограничение: Baseline up to approximately 4.5 years
|
Baseline up to approximately 4.5 years
|
|
|
Mean Number of Doses of Atezolizumab
Временное ограничение: Baseline up to approximately 4.5 years
|
Baseline up to approximately 4.5 years
|
|
|
Percentage of Participants With Anti-drug Antibodies (ADAs) to Atezolizumab
Временное ограничение: Baseline up to 4.5 years
|
Baseline up to 4.5 years
|
|
|
Serum Concentration of Atezolizumab
Временное ограничение: 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
|
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
|
|
|
Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR)
Временное ограничение: 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)
|
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.
|
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)
|
|
ORR Based on Modified RECIST v1.1
Временное ограничение: 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)
|
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.
|
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)
|
|
CBR Based on Modified RECIST v1.1
Временное ограничение: 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)
|
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.
|
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)
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
16 июля 2015 г.
Первичное завершение (Действительный)
4 апреля 2018 г.
Завершение исследования (Действительный)
28 июля 2020 г.
Даты регистрации исследования
Первый отправленный
28 мая 2015 г.
Впервые представлено, что соответствует критериям контроля качества
28 мая 2015 г.
Первый опубликованный (Оценивать)
1 июня 2015 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
4 июня 2021 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
11 мая 2021 г.
Последняя проверка
1 мая 2021 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- MO29518
- 2015-000269-30 (Номер EudraCT)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .