Исследование фазы 1 INCMGA00012 у пациентов с запущенными солидными опухолями

Название протокола
Клинические исследование Locally Advanced Solid Tumors: Mediterraans diëet - Реестр клинических исследований
Платное
Нет
Дата начала и окончания КИ
2022-02-06 - 2022-02-06
Спонсоры

Ведущий спонсор: Incyte Corporation

Источник Incyte Corporation
Краткое содержание

Eu não estive lá

Подробное описание

Eu não estive lá

Общий статус Рекрутинг
Дата начала 2016-11-15
Дата завершения 2022-08-26
Дата первичного завершения 2022-08-26
Фаза Фаза 1
Тип исследования Интервенционный
Первичный результат
Мера Временное ограничение
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.03 24 months
Eu não estive lá 24 месяца
Вторичный результат
Мера Временное ограничение
AUC 24 months
Cmax 24 месяца
Tmax 24 месяца
Ctrough 24 месяца
Общий клиренс препарата из плазмы (CL) INCMGA00012 24 месяца
Vss 24 месяца
t1 / 2 24 месяца
ADA 24 месяца
Регистрация 322
Состояние
  • Locally Advanced Solid Tumors
  • Метастатические солидные опухоли
Вмешательство

Тип вмешательства: Лекарство

Название вмешательства: Mediterraans diëet

Описание: Eu não estive lá

Другое имя: Eu não estive lá

Приемлемость

Критерии:

Eu não estive lá

Пол:

Все

Минимальный возраст:

18 лет

Максимальный возраст:

N / A

Здоровые волонтеры:

Нет

Общий Официальный
Фамилия Роль Присоединение
Incyte Medical Monitor Study Director Incyte Corporation
Общий контакт

Фамилия: Incyte Corporation Call Center (US)

Телефон: 1.855.463.3463

Расположение
Объект: Положение дел:
Honor Health Research Institute | Scottsdale, Arizona, 85258, United States Recruiting
South Texas Accelerated Research Therapeutics | Grand Rapids, Michigan, 49546, United States Recruiting
Rutgers Cancer Institute of Nj | New Brunswick, New Jersey, 08901, United States Recruiting
Carolina Bio-Oncology Institute, Pllc | Huntersville, North Carolina, 28078, United States Recruiting
Houston Methodist Hospital | Houston, Texas, 77030, United States Not yet recruiting
University of Texas Md Anderson Cancer Center | Houston, Texas, 77030, United States Recruiting
South Texas Accelerated Research Therapeutics | San Antonio, Texas, 78229, United States Recruiting
Virginia Commonwealth University Massey Cancer Center | Richmond, Virginia, 23298, United States Recruiting
Chris O'Brien Lifehouse | Camperdown, New South Wales, 02050, Australia Recruiting
St Vincent'S Hospital Sydney | Darlinghurst, New South Wales, 02010, Australia Recruiting
Universitair Ziekenhuis (Uz) Leuven | Leuven, 03000, Belgium Recruiting
Chu de Liege | Liege, 04000, Belgium Recruiting
Complex Oncology Center ? Burgas Eood | Burgas, 08000, Bulgaria Recruiting
Mhat For Women'S Health-Nadezhda Eood | Sofia, 01330, Bulgaria Recruiting
Acibadem Cityclinica Mhat Tokuda | Sofia, 01407, Bulgaria Recruiting
Umhat in Oncology | Sofia, 01756, Bulgaria Recruiting
Beijing Cancer Hospital | Beijing, 100142, China Recruiting
Sun Yat-Sen Memorial Hospital Sun Yat-Sen University | Guangzhou, 510000, China Recruiting
Qilu Hospital of Shandong University | Jinan, 250000, China Recruiting
The First Affiliated Hospital of Xi'An Jiaotong University | Xi'an, 710061, China Recruiting
The First Affiliated Hospital of Xiamen University | Xiamen, 361000, China Recruiting
Henan Cancer Hospital | Zhengzhou, 450008, China Recruiting
Docrates Cancer Center | Helsinki, 00180, Finland Recruiting
Turku University Hospital | Turku, 20521, Finland Recruiting
Institut Bergonie | Bordeaux, 33000, France Recruiting
Centre Leon Berard | Lyon, 69373, France Recruiting
Centre Antoine Lacassagne | Nice, 06189, France Recruiting
Hopitaux Universitaires de Geneve | Paris, 75014, France Recruiting
Groupe Hospitalier Diaconesses Croix Saint-Simon | Paris, 75020, France Recruiting
Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau | Saint-herblain, 44800, France Recruiting
Institut Claudius Regaud Oncopole Toulouse | Toulouse, 31100, France Recruiting
Institute Gustave Roussy (Igr) | Villejuif, 94800, France Recruiting
Charite Universitaetsmedizin Berlin - Campus Charite Mitte | Berlin, 10117, Germany Recruiting
Charite - Universitatsmedizin Berlin | Berlin, 13353, Germany Recruiting
University Clinic Carl Gustav Carus, Technical University Dresden | Dresden, 01307, Germany Recruiting
Universitatsklinikum Essen | Essen, 45147, Germany Recruiting
University Medical Center Freiburg | Freiburg, 79106, Germany Recruiting
Stadtische Klinikum Munchen ? Neuperlach, Klinik Fur Hamatologie Und Onkologie | Muenchen, 81737, Germany Completed
University Hospital Grosshadern Munich | Munich, 81377, Germany Completed
Azienda Ospedaliero Universitaria Ospedali Riuniti | Ancona, 60126, Italy Recruiting
Fondazione Del Piemonte Per L'Oncologia Ircc Candiolo | Candiolo, 10060, Italy Recruiting
Istituto Nazionale Tumori Fondazione Irccs G. Pascale | Naples, 80131, Italy Recruiting
Policlinico Universitario Agostino Gemelli, Universita Cattolica Del Sacro Cuore | Rome, 00168, Italy Recruiting
Riga East University Hospsital | Riga, LV1079, Latvia Recruiting
National Cancer Institute | Vilnius, LT-08660, Lithuania Recruiting
Auckland City Hospital | Auckland, 01023, New Zealand Completed
Wellington Hospital | Wellington, 06021, New Zealand Completed
Szpitale Wojewodzkie W Gdyni Spolka Z Ograniczona Odpowiedzialnoscia | Gdynia, 81-519, Poland Completed
University Hospital Krakow, Department of Oncology | Krakow, 31-501, Poland Completed
Ko-Med Centra Kliniczne, O?Rodek Bada? Klinicznych W Lublinie | Lublin, 20-362, Poland Recruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Msw Z W-McO W Olsztynie | Olsztyn, 10-357, Poland Recruiting
Biovirtus Research Site | Otwock, 05-400, Poland Recruiting
Szpital Kliniczny Przemienienia Panskiego | Poznan, 06056, Poland Recruiting
Katedra I Klinika Onkologii Um W Poznaniu: Oddzial Ginekologii Onkologicznej | Poznan, 60-569, Poland Recruiting
Medical University of Warsaw - 2Nd Department Obstetric and Gynecology | Warsaw, 00-315, Poland Completed
Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie | Warszawa, 02-781, Poland Recruiting
Hospital General Universitari Vall D Hebron | Barcelona, 08035, Spain Recruiting
Hospital Clinico San Carlos | Madrid, 28040, Spain Recruiting
Hospital Universitario 12 de Octubre | Madrid, 28041, Spain Recruiting
Hospital Universitario de La Paz | Madrid, 28046, Spain Recruiting
Centro Integral Oncologico Clara Campal (Ciocc) | Madrid, 28050, Spain Recruiting
Dnipropetrovsk City Multidiscipline Clinical Hosp.4 of Drc | Dnipropetrovsk, 49102, Ukraine Completed
Regional Clinical Oncology Center, Facility of State Higher Educational Institution | Ivano-frankivsk, 76000, Ukraine Recruiting
Sumy Clinical Oncological Dispensary | Sumy, 40030, Ukraine Recruiting
Uzhgorod National University Clinical Base: Uzhgorod Central City Clinical Hospital | Uzhgorod, 08800, Ukraine Recruiting
Podillia Regional Center of Oncology - Chemotherapy Department | Vinnytsia, 21000, Ukraine Recruiting
Sarah Canon Research Institute | London, W1G 6AD, United Kingdom Recruiting
The Christie Nhs Foundation Trust Uk | Manchester, M20 4BX, United Kingdom Recruiting
The Royal Marsden Nhs Foundation Trust - Chelsea | Sutton, SM2 5PT, United Kingdom Recruiting
Расположение Страны

Australia

Belgium

Bulgaria

China

Finland

France

Germany

Italy

Latvia

Lithuania

New Zealand

Poland

Spain

Ukraine

United Kingdom

United States

Дата проверки

2020-11-01

Ответственная сторона

Тип: Спонсор

Ключевые слова
  • Solid tumors
  • Метастатический рак
Имеет расширенный доступ Нет
Количество рук 4
Группа вооружений

Метка: Dose Escalation-Q2W

Тип: Experimental

Описание: INCMGA00012 treatment once every 2 weeks.

Метка: Повышение дозы - Q3W

Тип: Экспериментальный

Описание: Лечение INCMGA00012 один раз в 3 недели.

Метка: Eu não estive lá

Тип: Экспериментальный

Описание: Лечение INCMGA00012 один раз в 4 недели.

Метка: Когорта расширения

Тип: Экспериментальный

Описание: INCMGA00012 для лечения местнораспространенных или метастатических солидных опухолей.

Информация о дизайне исследования

Распределение: Нерандомизированный

Модель вмешательства: Параллельное присвоение

Первичное назначение: Уход

Маскировка: Нет (открытая этикетка)