Исследование эрдафитиниба по сравнению с винфлунином, доцетакселом или пембролизума у ​​распространенным уротелиальным раком и определенными аберрациями гена рецептора фактора роста фибробластов (FGFR)

Название протокола
Клинические исследование Уротелиальный рак: Erdafitinib, Винфлунин, Доцетаксел, Пембролизумаб, Клинические испытания ингибитора рецептора фактора роста фибробластов (FGFRi CTA) - Реестр клинических исследований
Платное
Нет
Дата начала и окончания КИ
2022-02-06 - 2022-02-06
Спонсоры

Ведущий спонсор: Janssen Research & Development, LLC

Источник Janssen Research & Development, LLC
Краткое содержание

Целью этого исследования является оценка эффективности эрдафитиниба по сравнению с химиотерапией пембролизумаб у участников с распространенным уротелиальным раком, несущим выбранные фибробласты аберрации рецептора фактора роста (FGFR), которые прогрессировали после 1 или 2 предшествующих процедур, по крайней мере 1 из которых включает агент антипрограммируемой смерти 1 (PD- [L] 1) агент (когорта 1) или 1 предшествующее лечение, не содержащее анти-PD- (L) 1 агента (когорта 2).

Подробное описание

Исследование эрдафитиниба в сравнении со стандартным лечением, состоящим из химиотерапии (доцетаксел) винфлунин) или анти-PD- (L) 1 агент пембролизумаб у участников с развитым уротелиальным рак и отдельные аберрации FGFR, которые прогрессировали после 1 или 2 предшествующих процедур или после них, по крайней мере, 1 из которых включает 1 агент (когорта 1) или 1 предшествующее лечение не содержит анти-PD- (L) 1 агент (когорта 2). Он будет состоять из обследований, фазы лечения. (от рандомизации до прогрессирования заболеваний, недопустимой токсичности, согласия или согласия решение исследователя о прекращении лечения, последующее наблюдение после лечения (с конец лечения до момента наступления, потеря для последующего наблюдения или конец изучение, в зависимости от того, что наступит раньше). Эффективность, фармакокинетика, биомаркеры, данные пациента результаты, медицинские ресурсы и безопасность использования оценены.

Общий статус Рекрутинг
Дата начала 2018-03-23
Дата завершения 2027-02-19
Дата первичного завершения 2024-04-23
Фаза Фаза 3
Тип исследования Интервенционный
Первичный результат
Мера Временное ограничение
Общее выживание (ОС) Дата первой рандомизации до даты смерти участника (примерно до 3 лет)
Вторичный результат
Мера Временное ограничение
Progression-free Survival (PFS) Date of randomization to the date of disease progression or relapse from complete response (CR) or death, whichever is reported first (approximately up to 3 years)
Общий коэффициент отклика (ORR) Примерно до 3 лет
Изменение по сравнению с исходным уровнем шкал состояния здоровья и физического функционирования участников функциональной оценки противоопухолевой терапии (FACT-Bl) Исходный уровень до конца лечения (примерно 3 года)
Время до ухудшения симптомов (подмножество элементов FACT-BI) Исходный уровень до конца лечения (примерно 3 года)
Изменение по сравнению с исходным уровнем оценки общего впечатления от тяжести пациента (PGIS) Исходный уровень до конца лечения (примерно 3 года)
Изменение от базовой линии в визуальной аналоговой шкале (ВАШ) EQ-5D-5L Исходный уровень до фазы последующего наблюдения (примерно 3 года)
Изменение от базовой линии в шкале полезности EQ-5D-5L Исходный уровень до фазы последующего наблюдения (примерно 3 года)
Продолжительность ответа (DOR) С даты первоначального документирования ответа до даты первых задокументированных свидетельств прогрессирующего заболевания (или рецидива у участников, у которых в ходе исследования возникла полная ремиссия) или смерти (примерно до 3 лет)
Количество участников с нежелательными явлениями (НЯ) как мера безопасности Примерно до 3 лет
Оральный клиренс (CL / F) Эрдафитиниба День 14 (цикл 1), День 1 (цикл 2) (каждый цикл состоит из 21 дня)
Площадь под кривой «концентрация в плазме - время» от нулевого времени до времени «t» (AUC [0-t]) эрдафитиниба День 14 (цикл 1), День 1 (цикл 2) (каждый цикл состоит из 21 дня)
Регистрация 631
Состояние
  • Уротелиальный рак
Вмешательство

Тип вмешательства: Drug

Название вмешательства: Erdafitinib

Описание: Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.

Другое имя: JNJ-42756493

Тип вмешательства: Лекарство

Название вмешательства: Винфлунин

Описание: Участники получат винфлунин 320 мг / м ^ 2 в виде 20-минутной внутривенной инфузии.

Этикетка Arm Group: Когорта 1 (группа 1B): винфлунин или доцетаксел

Тип вмешательства: Лекарство

Название вмешательства: Доцетаксел

Описание: Участники получат доцетаксел 75 мг / м ^ 2 в виде 1-часовой внутривенной инфузии.

Этикетка Arm Group: Когорта 1 (группа 1B): винфлунин или доцетаксел

Тип вмешательства: Лекарство

Название вмешательства: Пембролизумаб

Описание: Участники получат пембролизумаб 200 мг в виде 30-минутной внутривенной инфузии.

Этикетка Arm Group: Когорта 2 (группа 2B): пембролизумаб

Тип вмешательства: Устройство

Название вмешательства: Клинические испытания ингибитора рецептора фактора роста фибробластов (FGFRi CTA)

Описание: FGFRi CTA будет Роман для поиска молекулярной пригодности.

Приемлемость

Критерии:

Критерии включения: - Гистологическое подтверждение переходно-клеточной карциномы уротелия. Незначительный компоненты (менее [

Пол:

Все

Минимальный возраст:

18 лет

Максимальный возраст:

N / A

Здоровые волонтеры:

Нет

Общий Официальный
Фамилия Роль Присоединение
Janssen Research & Development, LLC Clinical Trial Study Director Janssen Research & Development, LLC
Общий контакт

Фамилия: Study Contact

Телефон: 844-434-4210

Расположение
Объект: Положение дел:
Alaska Urological Institute dba Alaska Clinical Research Center | Anchorage, Alaska, 99503, United States Completed
University Of UA Cancer Center(UACC)/DH-SJHMC | Phoenix, Arizona, 85004, United States Withdrawn
University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center | Orange, California, 92868, United States Withdrawn
University of Calif Davis Medical Center | Sacramento, California, 95817, United States Recruiting
St. Helena Hospital - Martin-O'Neil Cancer Center | Saint Helena, California, 94574, United States Completed
Kaiser Permanente Medical Center | Vallejo, California, 95119, United States Withdrawn
UCHealth Anschutz Cancer Pavilion | Aurora, Colorado, 80045, United States Withdrawn
MedStar Georgetown University Hospital | Washington, District of Columbia, 20007, United States Recruiting
University of Miami/Sylvester Cancer Center | Miami, Florida, 33136, United States Recruiting
Mid-Florida Hematology Oncology | Orange, Florida, 32763, United States Completed
Piedmont Cancer Institute | Atlanta, Georgia, 30318-0922, United States Completed
St. Luke's Meridian Medical Center | Meridian, Idaho, 83642, United States Withdrawn
Rush University | Chicago, Illinois, 60612, United States Recruiting
Edward Hines Jr V A Hospital | Hines, Illinois, 60141, United States Recruiting
Norton Cancer Institute | Louisville, Kentucky, 40207, United States Recruiting
Maryland Oncology Hematology, PA | Lanham, Maryland, 20706, United States Recruiting
University of Michigan Health System | Ann Arbor, Michigan, 48109-5000, United States Completed
University of Nebraska Medical Center | Omaha, Nebraska, 68198-0600, United States Withdrawn
VA Sierra Nevada Health Care System | Reno, Nevada, 89509, United States Recruiting
Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire, 03756, United States Recruiting
Montefiore Medical Center | Bronx, New York, 10461, United States Recruiting
Weill Cornell Medical College | New York, New York, 10029, United States Completed
Memorial Sloan-Kettering Cancer Center | New York, New York, 10065, United States Withdrawn
Levine Cancer Institute, Carolinas HealthCare System | Charlotte, North Carolina, 28204, United States Recruiting
Duke University | Durham, North Carolina, 27701, United States Withdrawn
W. G. 'Bill' Hefner VA Medical Center | Salisbury, North Carolina, 28144, United States Completed
Oncology Hematology Care | Cincinnati, Ohio, 45242, United States Recruiting
Penn State Hershey Cancer Institute | Hershey, Pennsylvania, 17033, United States Withdrawn
University of Pittsburgh Medical Center (UPMC) | Pittsburgh, Pennsylvania, 15232, United States Withdrawn
University of Missouri | Columbia, South Carolina, 65212-1000, United States Withdrawn
The Center for Cancer and Blood Disorders | Fort Worth, Texas, 76104, United States Recruiting
Texas Oncology-Memorial City | Houston, Texas, 77024, United States Recruiting
MD Anderson Cancer Center | Houston, Texas, 77030, United States Recruiting
Texas Oncology-Tyler | Tyler, Texas, 75702, United States Recruiting
INOVA Dwiight &Martha Schar Cancer Institute | Fairfax, Virginia, 22031, United States Recruiting
Virginia Oncology Associates | Norfolk, Virginia, 23502, United States Recruiting
VA Puget Sound Healthcare System | Seattle, Washington, 98108, United States Completed
Hospital Italiano de Buenos Aires | Buenos Aires, C1181ACH, Argentina Withdrawn
Hospital Sirio Libanes | Buenos Aires, C1419AHN, Argentina Recruiting
Fundación CENIT para la Investigación en Neurociencias | Capital Federal, CP 1125, Argentina Recruiting
CEMIC Saavedra | Ciudad Autonoma de Buenos Aires, C1431FWN, Argentina Recruiting
Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica | Cordoba, C5000, Argentina Recruiting
Centro Urologico Profesor Bengio | Cordoba, X5000KPH, Argentina Recruiting
Hospital Privado de Comunidad | Mar Del Plata, B7602CBM, Argentina Not yet recruiting
Centro de Investigacion Pergamino SA | Pergamino, B2700CPM, Argentina Not yet recruiting
Clínica Viedma | Viedma, R8500ACE, Argentina Recruiting
Chris O'Brien Lifehouse | Camperdown, 2050, Australia Recruiting
Peninsula & South Eastern Haematology and Oncology Group | Frankston, 3199, Australia Recruiting
St George Hospital | Kogarah, 2217, Australia Recruiting
Peter MacCallum Cancer Centre | Melbourne, 3000, Australia Recruiting
Frankston Hospital | Melbourne, 3199, Australia Recruiting
Fiona Stanley Hospital | Murdoch, 6150, Australia Recruiting
Macquarie University | North Ryde, 2109, Australia Withdrawn
LKH-Univ. Klinikum Graz | Graz, 8036, Austria Recruiting
Ordensklinikum Linz GmbH Elisabethinen | Linz, 4020, Austria Recruiting
LKH - Universitätsklinikum der PMU Salzburg | Salzburg, 5020, Austria Recruiting
Krankenhaus der Barmherzigen Brüder | Vienna, 1020, Austria Not yet recruiting
Medical University Vienna, MUV | Vienna, A-1090, Austria Recruiting
OLV Ziekenhuis Aalst | Aalst, 9300, Belgium Recruiting
ZNA Middelheim | Antwerpen, 2020, Belgium Recruiting
Cliniques Universitaires Saint-Luc | Brussel, 1200, Belgium Recruiting
Clinique Notre Dame de Grâce | Charleroi, 6000, Belgium Recruiting
AZ Maria Middelares | Gent, 9000, Belgium Recruiting
UZ Gent | Gent, 9000, Belgium Recruiting
CHC MontLegia | Liege, 4000, Belgium Recruiting
Sint-Augustinus AZ | Wilrijk, 2610, Belgium Completed
CHU UCL Namur - Site Godinne | Yvoir, 5530, Belgium Recruiting
Fundacao Pio Xii - Hospital De Cancer De Barretos | Barretos, 14784-400, Brazil Recruiting
Hospital Das Clinicas Da Universidade Federal De Minas Gerais | Belo Horizonte, 30130-100, Brazil Recruiting
Associação Mário Penna/Núcleo de Ensino e Pesquisas | Belo Horizonte, 30380-472, Brazil Recruiting
Instituto de Oncologia do Paraná | Curitiba, 80530-010, Brazil Not yet recruiting
Hospital Erasto Gaertner | Curitiba, 81520-060, Brazil Recruiting
Hospital Araújo Jorge da Associação de Combate ao Câncer em Goiás | Goiânia, 74605-070, Brazil Recruiting
Clínica de Neoplasias Litoral Ltda. | Itajai, 88301-220, Brazil Recruiting
Centro de Pesquisas do Hospital Amaral Carvalho | Jaú, 17210-080, Brazil Not yet recruiting
Liga Norte Riograndense Contra O Cancer | Natal, 59075-740, Brazil Recruiting
Irmandade da Santa Casa de Misericordia de Porto Alegre | Porto Alegre, 90020-090, Brazil Not yet recruiting
Upco - Hcpa | Porto Alegre, 90035-903, Brazil Recruiting
Hospital Conceicao | Porto Alegre, 91410-330, Brazil Not yet recruiting
INCA - Instituto Nacional Do Cancer | Rio de Janeiro, 20231-050, Brazil Recruiting
Oncoclínicas | Rio De Janeiro, 22250-905, Brazil Recruiting
Hospital Sao Rafael | Salvador, 41253-190, Brazil Recruiting
Fundacao Antonio Prudente | Sao Paulo, 01509900, Brazil Recruiting
Ibcc - Instituto Brasileiro de Controle Do Cancer | Sao Paulo, Brazil Recruiting
Instituto de Oncologia de Sorocaba/Onco Clinicas Especializadas | Sorocaba, 18030-005, Brazil Recruiting
Hospital de Base de São José do Rio Preto | São José do Rio Preto, 15090-000, Brazil Recruiting
Sociedade Beneficiante de Senhoras - Hospital Sirio Libanes | São Paulo, 01308901, Brazil Recruiting
Instituto D'Or de Pesquisa e Ensino (IDOR) | São Paulo, 04502-001, Brazil Recruiting
Hospital Israelita Albert Einstein | São Paulo, 05651-900, Brazil Not yet recruiting
CEPHO - Faculdade de Medicina do ABC | São Paulo, 09060-650, Brazil Recruiting
UMHAT 'Dr. Georgi Stranski', EAD | Pleven, 5800, Bulgaria Not yet recruiting
District Oncology Dispensary with In-Patient Stationary - Plovdiv | Plovdiv, 4004, Bulgaria Not yet recruiting
Multiprofile Hospital for Active Treatment 'Tokuda Hospital Sofia' | Sofia, 1407, Bulgaria Not yet recruiting
UMHAT Sofia Med | Sofia, 1797, Bulgaria Not yet recruiting
Multiprofile Hospital for Active Treatment 'Sveta Marina' EAD | Varna, 9010, Bulgaria Not yet recruiting
BC Cancer Agency - Southern Interior | Kelowna, British Columbia, V1Y 5L3, Canada Recruiting
Vancouver Cancer Centre | Vancouver, British Columbia, V5Z 4E6, Canada Recruiting
Cancercare Manitoba | Winnipeg, Manitoba, R3E 0V9, Canada Recruiting
Thunder Bay Regional Health Sciences Centre | Thunder Bay, Ontario, P7B 6V4, Canada Recruiting
Princess Margaret Hospital- UHN | Toronto, Ontario, M5G 2M9, Canada Completed
Saskatchewan Cancer Agency (SCA) - Allan Blair Cancer Centre | Regina, Saskatchewan, S4T 7T1, Canada Recruiting
Cancer Hospital Chinese Academy of Medical Sciences | Beijing, 100021, China Recruiting
Peking University First Hospital | Beijing, 100034, China Recruiting
Beijing Friendship Hospital | Beijing, 100050, China Recruiting
Peking University Third Hospital | Beijing, 100191, China Recruiting
Beijing Hospital | BeiJing, 100730, China Recruiting
Peking Union Medical College Hospital | Beijing, 100730, China Recruiting
The First Bethune Hospital of Jilin University | Changchun, 130021, China Not yet recruiting
Sichuan Provincial People's Hospital | Chengdu, 610000, China Recruiting
Sichuan University Huaxi Hospital | Chengdu, 610041, China Recruiting
Chongqing Cancer hospital | ChongQing, 400030, China Recruiting
Sun Yat-Sen University Cancer Center | Guangzhou, 510060, China Recruiting
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University | Guangzhou, 510120, China Recruiting
Guangzhou First Municipal People's Hospital | Guangzhou, 510180, China Recruiting
Zhejiang Provincial People's Hospital | Hangzhou, 310014, China Recruiting
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Hangzhou, 310020, China Recruiting
The First Affliated Hospital Of Nanchang University | Nanchang, 330006, China Recruiting
Nanjing Drum Tower Hospital | Nanjing, 210008, China Recruiting
Jiangsu Cancer Hospital | Nanjing, 210009, China Recruiting
Renji Hospital, Shanghai Jiaotong University School of Medicine | ShangHai, 200127, China Recruiting
Huadong Hospital Affiliated to Fudan University | Shanghai, 200400, China Recruiting
Shengjing Hospital of China Medical University | Shenyang, 110004, China Recruiting
Liaoning Cancer Hospital & Institute | Shenyang, 110042, China Not yet recruiting
Shenzhen university General Hospital | Shenzhen, 518055, China Not yet recruiting
First Affiliated Hospital of Wenzhou Medical College | Wenzhou, 325000, China Not yet recruiting
First Affiliated Hospital, Xi'an Jiaotong University | Xi'an, 710061, China Recruiting
Rigshospitalet | Copenhagen, 2100, Denmark Not yet recruiting
Herlev Hospital | Herlev, 2730, Denmark Not yet recruiting
Institut de Cancérologie de l'Ouest (ICO) | Angers, 49055, France Recruiting
Hopital Jean MINJOZ | Besancon Cedex, 25030, France Recruiting
Institut Bergonié | Bordeaux, 33000, France Recruiting
CHRU Brest - Hôpital Morvan | Brest, 29609, France Recruiting
Centre Jean Perrin | Clermont Ferrand, 63011, France Recruiting
Centre Georges-François Leclerc | Dijon, 21079, France Recruiting
CHU Grenoble | Grenoble, 38043 Cedex 9, France Withdrawn
Clinique Sainte-Marguerite | Hyers, 83400, France Withdrawn
Centre Oscar Lambret | Lille, 59020, France Recruiting
Groupe Hospitalier Bretagne Sud | Lorient, 56322, France Recruiting
Centre Leon Bérard | Lyon, 69008, France Withdrawn
Hopital de la Timone | Marseille, 13005, France Recruiting
Institut Regional du Cancer de Montpellier Val d'Aurelle | Montpellier, 34298, France Recruiting
Centre Antoine Lacassagne | Nice, 06189, France Recruiting
Institut de Cancérologie du Gard | Nîmes, 30029, France Recruiting
Hospital Saint-Louis | Paris Cedex 10, 75475, France Terminated
Hopital Europeen Georges-Pompidou | Paris, 75015, France Recruiting
Hospices Civils de Lyon HCL | Pierre-Bénite, 69495, France Recruiting
CHU De Poitiers | Poitiers Cedex, 86021, France Recruiting
Institut Jean Godinot | Reims, 51100, France Not yet recruiting
Centre Eugene Marquis | Rennes Cedex, 35062, France Recruiting
Centre de radiothérapie et d'Oncologie médicale de l'Essonne | Ris Orangis, 91130, France Recruiting
I.C.O. René Gauducheau | Saint Herblain Cedex, 44805, France Withdrawn
Institut de Cancérologie de Loire | Saint-Priest-en-Jarez, 42271, France Recruiting
Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre | Strasbourg Cedex, 67098, France Recruiting
Institut Claudius Regaud | Toulouse, 31059, France Recruiting
Centre Les Dentellieres | Valenciennes, 59300, France Recruiting
Institut Gustave Roussy | Villejuif, 94805, France Recruiting
Vivantes Klinikum Am Urban | Berlin, 10967, Germany Recruiting
Städtisches Klinikum Braunschweig gGmbH-Klinik für Urologie und Uroonkologie | Braunschweig, 38126, Germany Recruiting
Universitatsklinikum Carl Gustav Carcus Dresden | Dresden, 01307, Germany Recruiting
Universitaetsklinikum Duesseldorf | Duesseldorf, 40225, Germany Recruiting
Urologicum Duisburg | Duisburg, 47179, Germany Withdrawn
Friedrich-Alexander Universitaet Urologische Universitaetskl | Erlangen, 91054, Germany Recruiting
Universitatsklinikum Frankfurt | Frankfurt, 60590, Germany Recruiting
Universitatsklinikum Freiburg | Freiburg, 79106, Germany Completed
Universitätsmedizin Greifswald | Greifswald, 17475, Germany Suspended
Universitätsmedizin Göttingen | Göttingen, 37099, Germany Recruiting
Asklepios Klinik Altona | Hamburg, 22763, Germany Recruiting
Medizinische Hochschule Hannover | Hannover, 30625, Germany Recruiting
Marienhospital Herne | Herne, 44625, Germany Not yet recruiting
Universitätsklinikum des Saarlandes | Homburg/Saar, 66421, Germany Withdrawn
Universitätsklinikum Schleswig Holstein Campus Lübeck | Lubeck, 23538, Germany Recruiting
Universitätsmedizin der Johannes Gutenberg-Universität Mainz | Mainz, 55131, Germany Not yet recruiting
Medizinische Fakultät Mannheim der Universität Heidelberg | Mannheim, 68167, Germany Recruiting
Universitaetsklinikum Muenster | Muenster, 48149, Germany Recruiting
Studienpraxis Urologie Drs. Feyerabend | Nuertingen, 72622, Germany Recruiting
Caritas-Krankenhaus St. Josef | Regensburg, 93053, Germany Recruiting
Universitaetsmedizin Rostock | Rostock, 18057, Germany Recruiting
Universitaetsklinikum Tuebingen | Tuebingen, 72076, Germany Not yet recruiting
MVZ-Onkologie Velbert GbR | Velbert, 42551, Germany Recruiting
Kliniken Nordoberpfalz AG/Klinikum Weiden | Weiden, 92637, Germany Recruiting
University General Hospital of Rio Patras | Achaïa, 26504, Greece Recruiting
Errikos Dunant Hospital Center | Athens, 11526, Greece Recruiting
Athens Medical Center | Athens, 15125, Greece Recruiting
Metropolitan General A.E. | Athens, 15562, Greece Recruiting
University of Athens Medical School - Regional General Hospi | Athina, 115 28, Greece Recruiting
University Hospital Of Larissa | Larisa, 41110, Greece Recruiting
Interbalkan European Medical Center | Thessaloniki, 14564, Greece Recruiting
Euromedica General Clinic | Thessaloniki, 54645, Greece Recruiting
'Papageorgiou' General Hospital of Thessaloniki | Thessaloniki, 56403, Greece Recruiting
Semmelweis Egyetem | Budapest, 1082, Hungary Recruiting
Orszagos Onkologiai Intezet | Budapest, 1122, Hungary Recruiting
Uzsoki Utcai Korhaz | Budapest, H-1145, Hungary Recruiting
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz | Nyíregyháza, 04400, Hungary Completed
Pecsi Tudomanyegyetem Klinikai Kozpont | Pécs, 7624, Hungary Recruiting
Zala Megyei Szent Rafael Korhaz | Zalaegerszeg, 8900, Hungary Not yet recruiting
Rambam Health Care Campus | Haifa, 31096, Israel Recruiting
Hadassah Medical Center | Jerusalem, 91120, Israel Recruiting
Meir Medical Center | Kfar Saba, 44281, Israel Recruiting
Rabin Medical Center, Beilinson Hospital | Petach Tikvah, 49100, Israel Recruiting
The Chaim Sheba Medical Center | Tel Hashomer, 52621, Israel Recruiting
Sourasky Medical Center | Tel-Aviv, 64239, Israel Recruiting
Assaf Harofeh Medical Center | Zerifin, 70300, Israel Recruiting
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo Alessandria | Alessandria, 15121, Italy Recruiting
Ospedale S. Donato - Asl 8 Arezzo | Arezzo, 52100, Italy Recruiting
CRO, IRCCS, Istituto Nazionale Tumori | Aviano, 33081, Italy Recruiting
Azienda Ospedaliera Papa Giovanni XXIII | Bergamo, 24127, Italy Recruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili | Brescia, 25123, Italy Recruiting
Istituti Ospitalieri di Cremona, AO di Cremona | Cremona, 26100, Italy Recruiting
Oncologia Medica | Firenze, 50139, Italy Recruiting
Policlinico Hospital San Martino- IRCCS for Oncology | Genova, 16132, Italy Withdrawn
SPDC Villa Scassi | Genova, Italy Recruiting
UOC Oncologia Ospedale Provinciale di Macerata | Macerata, 62100, Italy Recruiting
IRST Meldola - Forlì | Meldola, 47014, Italy Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori | Milano, 20133, Italy Recruiting
European Institute of Oncology | Milano, 20141, Italy Recruiting
IRCCS Ospedale San Raffaele | Milan, 20132, Italy Not yet recruiting
AOU Policlinico di Modena | Modena, 41124, Italy Not yet recruiting
IRCCS-Fondazione Pascale | Napoli, 80131, Italy Recruiting
Ospedale Maggiore della Carità | Novara, 28100, Italy Recruiting
Aou San Luigi Gonzaga | Orbassano, 10043, Italy Recruiting
Istituto Oncologico Veneto Iov Irccs Padova | Padova, 35128, Italy Recruiting
AOU di Parma | Parma, 43126, Italy Recruiting
IRCCS Policlinico San Matteo | Pavia, 27100, Italy Recruiting
Ist. Clinici Scientifici Maugeri - Unità Operativa di Oncolo | Pavia, 27100, Italy Recruiting
Azienda Ospedaliero Universitaria Pisana | Pisa, 56126, Italy Recruiting
Usl 7 Siena - Ospedale Alta Valdelsa ASL TOSCANA SUD-EST | Poggibonsi (SI), 53100, Italy Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS | Roma, 00168, Italy Recruiting
Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte | Siena, 53100, Italy Recruiting
Oncologia Medica-Città Della Salute E Della Scienza Di Torino | Torino, 10123, Italy Recruiting
Azienda Ospedaliero - Universitaria Ospedali Riuniti | Torrette Di Ancona, 60126, Italy Recruiting
Chiba Cancer Center | Chiba, 260-8717, Japan Recruiting
Hirosaki University Hospital | Hirosaki, 036-8563, Japan Recruiting
National Cancer Center Hospital East | Kashiwa, 277-8577, Japan Recruiting
Kagawa University Hospital | Kita-Gun, 761-0793, Japan Recruiting
Kobe City Medical Center General Hospital | Kobe, 650-0047, Japan Recruiting
Dokkyo Medical University Saitama Medical Center | Koshigaya, 343-8555, Japan Recruiting
National Hospital Organizaiton Shikoku Cancer Center | Matsuyama, 791-0280, Japan Recruiting
University of Miyazaki Hospital | Miyazaki, 889-1692, Japan Recruiting
Nagano Municipal Hospital | Nagano, 381-8551, Japan Recruiting
Aichi Cancer Center Hospital | Nagoya-Shi, 464-8681, Japan Recruiting
Kindai University Hospital | Osaka-Sayama, 589-8511, Japan Recruiting
Osaka International Cancer Institute | Osaka-Shi, 541-8567, Japan Recruiting
Osaka City University Hospital | Osaka, 545-8586, Japan Recruiting
Gunma Prefectural Cancer Center | Ota, 373-8550, Japan Recruiting
Kitasato University Hospital | Sagamihara, 252-0375, Japan Recruiting
Toho University Sakura Medical Center | Sakura, 285-8741, Japan Recruiting
National Hospital Organization Hokkaido Cancer Center | Sapporo, 003-0804, Japan Recruiting
Tokyo Women's Medical University Hospital | Shinjuku-ku, 162-8666, Japan Recruiting
Toranomon Hospital | Tokyo, 105-8470, Japan Recruiting
The Cancer Institute Hospital of JFCR | Tokyo, 135-8550, Japan Recruiting
University of Tsukuba Hospital | Tsukuba, 305-8576, Japan Recruiting
Yamaguchi University Hospital | Ube, 755-8505, Japan Recruiting
Yokohama City University Medical Center | Yokohama, 232-0024, Japan Recruiting
Pusan National University Hospital. | Busan, 49241, Korea, Republic of Recruiting
Chungnam National University Hospital | Daejeon, 35015, Korea, Republic of Recruiting
National Cancer Center | Goyangsi, 410-769, Korea, Republic of Recruiting
Chonnam National University Hospital | Gwangju, 61469, Korea, Republic of Recruiting
Gachon University Gil Medical Center | Incheon, 21565, Korea, Republic of Recruiting
Seoul National University Bundang Hospital | Seongnam, 463-707, Korea, Republic of Recruiting
Korea University Anam Hospital | Seoul, 02841, Korea, Republic of Recruiting
Seoul National University Hospital | Seoul, 03080, Korea, Republic of Recruiting
Kangbuk Samsung Hospital | Seoul, 03181, Korea, Republic of Recruiting
Severance Hospital, Yonsei University Health System | Seoul, 03722, Korea, Republic of Recruiting
Samsung Medical Center | Seoul, 135-710, Korea, Republic of Recruiting
Yonsei University Wonju Severance Christian Hospital | Wonju-si, 26426, Korea, Republic of Recruiting
Medicos Especialistas en Cancer, S.C. | Aguascalientes, 20230, Mexico Recruiting
Centro Estatal de Cancerología de Chihuahua | Chihuahua, 31000, Mexico Completed
Oncología Integral Satelite | Naucalpan, 53100, Mexico Recruiting
NKI-AVL, Amsterdam | Amsterdam, 1066 CX, Netherlands Recruiting
Haga ziekenhuis | Den Haag, 2545 CH, Netherlands Recruiting
St. Antonius Ziekenhuis Nieuwegein | Nieuwegein, 3430 EM, Netherlands Recruiting
Radboud Umcn | Nijmegen, 6525 GA, Netherlands Withdrawn
Bialostockie Centrum Onkologii | Bialystok, 15-027, Poland Withdrawn
Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy | Bydgoszcz, 85-796, Poland Recruiting
Centralny Szpital Kliniczny MSWiA w Warszawie | Warszawa, 02-507, Poland Recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy | Warszawa, 02-781, Poland Recruiting
Uniwersytecki Szpital Kliniczny we Wrocławiu | Wroclaw, 50-556, Poland Recruiting
Hospital Lusíadas | Lisboa, 1500-458, Portugal Recruiting
H. Santa Maria - Centro Hospitalar de Lisboa Norte | Lisboa, 1649-035, Portugal Recruiting
Hospital Santo Antonio dos Capuchos | Lisboa, G1R 2J6, Portugal Recruiting
Champalimaud Foundation Champalimaud Centre | Lisbon, 1400-038, Portugal Recruiting
Instituto Portugues de Oncologia | Porto, 4200072, Portugal Recruiting
Altai Regional Oncology Dispensary | Barnaul, 656049, Russian Federation Recruiting
Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine | Chelyabinsk, 454087, Russian Federation Completed
Irkutsk Regional Oncology Dispensary | Irkutsk, 664035, Russian Federation Recruiting
Ivanovo Regional Oncology Dispensary | Ivanovo, 153040, Russian Federation Recruiting
Naval Clinical Hospital | Kaliningrad, 236029, Russian Federation Withdrawn
Kostroma regional oncology dispensary | Kostroma, 156005, Russian Federation Recruiting
Leningrad Regional Oncology Dispensary | Kuzmolovsky, 188663, Russian Federation Recruiting
City Clinical Hospital n.a. D.D.Pletnev | Moscow, 105077, Russian Federation Recruiting
FSBSI 'N. N. Blokhin Russian Cancer Research Center' | Moscow, 115478, Russian Federation Recruiting
Russian Scientific Center of Roentgenoradiology | Moscow, 117997, Russian Federation Completed
I.M. Sechenov First Moscow State Medical University | Moscow, 119991, Russian Federation Not yet recruiting
Hertzen Oncology Research Institute | Moscow, 125284, Russian Federation Recruiting
City Clinical Hospital #1 | Nalchik, 360017, Russian Federation Not yet recruiting
Privolzhsky District Medical Center under the Federal Medico-Biological Agency | Nizhni Novgorod, 603109, Russian Federation Recruiting
National Medical Radiological Research Center | Obninsk, 249036, Russian Federation Withdrawn
Clinical Oncology Dispensary | Omsk, 644013, Russian Federation Recruiting
GBUZ of Stavropol region Pyatigorsk Oncological Dispensary | Pyatigorsk, 357502, Russian Federation Completed
City Polyprofiled Hospital #2 | Saint Petersburg, 194354, Russian Federation Withdrawn
Private Medical Institution Euromedservice | Saint Petersburg, 196603, Russian Federation Recruiting
Pavlov First Saint Petersburg State Medical University | Saint Petersburg, 197022, Russian Federation Completed
LLC 'Strategic Medical Systems' | Saint-Petersburg, 192148, Russian Federation Recruiting
Clinical hopital n/a Petra velikogo | Saint-Petersburg, 195067, Russian Federation Recruiting
FGBOU Vo Mordovian National Research State University N. A. N.P. Ogareva | Saransk, 430032, Russian Federation Recruiting
Saratov State Medical University | Saratov, 410000, Russian Federation Recruiting
LLC Uromed | Smolensk, 214031, Russian Federation Recruiting
GBUZ Oncology Centre #2 of Healthcare Department of Krasno | Sochi, 354057, Russian Federation Recruiting
Russian Scientific Center of Radiology and Surgical Technologies | St. Petersburg, 197758, Russian Federation Recruiting
Saint-Petersburg Clinical Scientific And Practical Center For Special Types Of Medical Care | St.Petersburg, 197758, Russian Federation Completed
Multifunctional clinical medical center 'Medical city' | Tyumen, 625041, Russian Federation Recruiting
Bashkiria State Medical University | Ufa, 450000, Russian Federation Recruiting
Vologda Regional Oncological Dispensary | Vologda, 160012, Russian Federation Recruiting
Hosp. Univ. Infanta Cristina | Badajoz, 06006, Spain Recruiting
Institut Català D'Oncologia-Hospital Universitari Germans Trias I Pujol | Badalona, 08916, Spain Recruiting
Hosp. Clinic I Provincial de Barcelona | Barcelona, 08036, Spain Recruiting
Hosp. de La Santa Creu I Sant Pau | Barcelona, 08041, Spain Recruiting
Hosp. San Pedro de Alcantara | Cáceres, 10003, Spain Not yet recruiting
Hosp. Reina Sofia | Córdoba, 14004, Spain Recruiting
Hosp. Univ. Virgen de Las Nieves | Granada, 18014, Spain Recruiting
Complejo Hospitalario de Jaen | Jaén, 23007, Spain Recruiting
Hosp. Univ. Insular de Gran Canaria | Las Palmas de Gran Canaria, 35016, Spain Not yet recruiting
Hosp. Univ. Lucus Augusti | Lugo, 27003, Spain Recruiting
Hosp. Gral. Univ. Gregorio Marañon | Madrid, 28009, Spain Withdrawn
Centro Oncologico Md Anderson | Madrid, 28033, Spain Withdrawn
Hosp. Clinico San Carlos | Madrid, 28040, Spain Not yet recruiting
Hosp. Univ. La Paz | Madrid, 28046, Spain Recruiting
Hosp. Univ. 12 de Octubre | Madrid, 28051, Spain Not yet recruiting
Hosp. Univ. Pta. de Hierro Majadahonda | Majadahonda, 28220, Spain Recruiting
ALTHAIA, Xarxa Assistencial Universitària de Manresa | Manresa, 08243, Spain Recruiting
Hosp. Virgen de La Victoria | Málaga, 29010, Spain Withdrawn
Hosp. de Navarra | Pamplona, 31008, Spain Recruiting
Hosp. Virgen Macarena | Sevilla, 41009, Spain Recruiting
Hosp. Virgen Del Rocio | Sevilla, 41013, Spain Recruiting
Hosp. Gral. Univ. Valencia | Valencia, 46014, Spain Not yet recruiting
Hosp. Univ. I Politecni La Fe | Valencia, 46026, Spain Recruiting
Hosp. Univ. Miguel Servet | Zaragoza, 50009, Spain Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung, 807, Taiwan Recruiting
Chang Gung Medical Foundation | Niao-Sung Hsiang, 833, Taiwan Recruiting
Taichung Veterans General Hospital | Taichung, 40705, Taiwan Recruiting
National Cheng Kung University Hospital | Tainan, 70403, Taiwan Recruiting
Chi Mei Medical Center - Yong Kang | Tainan, 710, Taiwan Recruiting
National Taiwan University Hospital | Taipei City, 10002, Taiwan Recruiting
Mackay Memorial Hospital | Taipei, 10449, Taiwan Recruiting
Taipei Veterans General Hospital | Taipei, 11217, Taiwan Recruiting
Koo Foundation Sun Yat-Sen Cancer Center | Taipei, 11259, Taiwan Recruiting
Chang-Gung Memorial Hospital, LinKou Branch | Taoyuan, 333, Taiwan Recruiting
Baskent University Adana Practice and Research Center Kisla Health Campus | Adana, 01120, Turkey Recruiting
Hacettepe University Medical Faculty | Ankara, 6100, Turkey Recruiting
Bezmialem University Medical Faculty | Istanbul, 34093, Turkey Recruiting
Istanbul University Cerrahpasa Medical Faculty | Istanbul, 34098, Turkey Recruiting
Bakirkoy Training and Research Hospital | Istanbul, 34147, Turkey Recruiting
Medipol Mega University Hospital | Istanbul, 34214, Turkey Recruiting
T.C. Saglik Bakanlıgi Goztepe Prof. Dr. Suleyman Yalcın Sehir Hastanesi | Istanbul, 34722, Turkey Recruiting
Pendik Training and Research Hospital | Istanbul, 34890, Turkey Recruiting
Ege University | Izmir, 35100, Turkey Recruiting
Dokuz Eylul Universitesi Tip Fakultesi | Izmir, 35340, Turkey Recruiting
Izmir Katip Celebi University Ataturk Training and Research Hospital | Izmir, 35360, Turkey Not yet recruiting
Kocaeli University Medical Faculty | Kocaeli, Turkey Recruiting
Inonu Universitesi Turgut Ozal Tip Merkezi, Ic Hastaliklari | Malatya, 44400, Turkey Completed
Chernivtsi Regional Clinical Hospital | Chernivtsi, 58002, Ukraine Withdrawn
MI Dnipropetrovsk Region Clinical Hospital n a I.I.Mechnikov | Dnipropetrovsk, 49005, Ukraine Recruiting
Municipal Institution 'Clinical Oncology Dispensary' Under Dnipropetrovsk Regional Council | Dnipro, 49100, Ukraine Recruiting
Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4 | Dnipro, 49102, Ukraine Recruiting
Ivano-Frankivsk Regional Clinical Hospital | Ivano-Frankivsk, 76008, Ukraine Recruiting
Regional Medical Clinical Center for Urology and Nephrology named after V.I. Shapoval | Kharkiv, 61037, Ukraine Recruiting
Municipal non-profit enterprise 'Regional Center of Oncology' | Kharkiv, 61070, Ukraine Recruiting
National Cancer Institute | Kyiv, 03022, Ukraine Recruiting
State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center | Kyiv, 03115, Ukraine Recruiting
Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital' | Lviv, 79010, Ukraine Recruiting
Transkarpathian Regional University Oncology Clinic | Uzhgorod, 88000, Ukraine Recruiting
Podilskiy Regional Center of Oncology | Vinnitsa, 21029, Ukraine Recruiting
Zaokod | Zaporizhzhia, 69040, Ukraine Completed
Zaporizhzhia medical Academy of postgraduate education, Zaporizhzhia Regoinal Clinical Hospital | Zaporizhzhia, 69600, Ukraine Completed
University Hospitals Bristol - Bristol Haematology & Oncolog | Bristol, BS2 8ED, United Kingdom Recruiting
St Bartholomew's Hospital | London, EC1A 7BE, United Kingdom Recruiting
Sarah Cannon Research Institute | London, W1G 6AD, United Kingdom Recruiting
Charing Cross Hospital | London, W6 8RF, United Kingdom Recruiting
The Christie NHS Foundation Trust - Christie Hospital | Manchester, M20 4BX, United Kingdom Recruiting
Derriford Hospital-Department of Medical Oncology | Plymouth, PL6 8QH, United Kingdom Recruiting
University of Sheffield | Sheffield, S10 2 RX, United Kingdom Not yet recruiting
Southampton General Hospital | Southampton, SO16 6YD, United Kingdom Recruiting
Royal Marsden Hospital | Sutton, SM2 5NG, United Kingdom Recruiting
Расположение Страны

Argentina

Australia

Austria

Belgium

Brazil

Bulgaria

Canada

China

Denmark

France

Germany

Greece

Hungary

Israel

Italy

Japan

Korea, Republic of

Mexico

Netherlands

Poland

Portugal

Russian Federation

Spain

Taiwan

Turkey

Ukraine

United Kingdom

United States

Дата проверки

2021-04-01

Ответственная сторона

Тип: Спонсор

Имеет расширенный доступ да
Количество рук 4
Группа вооружений

Метка: Cohort 1 (Arm 1A): Erdafitinib

Тип: Experimental

Описание: Participants will be screened based on Fibroblast Growth Factor Receptor Inhibitor Clinical Trial Assay (FGFRi CTA) to determine molecular eligibility and participants who meet molecular eligibility criteria will be eligible for full study screening. Participants enrolled in the study (treated with prior anti-programmed cell death protein PD-[L] 1 agent) will swallow erdafitinib tablets orally at a starting dose of 8 milligram (mg), once daily for 21 days in a 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent or decision by the investigator to discontinue treatment. Dose adjustment are based on phosphate level and observed toxicity (adverse events [AEs]).

Метка: Когорта 1 (группа 1B): винфлунин или доцетаксел

Тип: Экспериментальный

Описание: Участники будут подвергнуты скринингу на основе FGFRi CTA для определения молекулярной пригодности, и участники, соответствующие критериям молекулярной пригодности, будут иметь право на полный скрининг исследования. Участники, включенные в исследование (ранее принимавшие анти-PD- [L] 1 агент), будут получать винфлунин 320 миллиграмм на квадратный метр (мг / м ^ 2) в виде 20-минутной внутривенной инфузии один раз каждые 3 недели или доцетаксела 75 мг / m ^ 2 в виде 1-часовой внутривенной инфузии каждые 3 недели. Лечение любым агентом (по выбору исследователя) будет проводиться до прогрессирования заболевания, возникновения недопустимой токсичности, отзыва согласия или решения исследователя о прекращении лечения. Корректировка дозы основана на наблюдаемой токсичности.

Метка: Когорта 2 (группа 2A): Эрдафитиниб

Тип: Экспериментальный

Описание: Участники будут подвергнуты скринингу на основе FGFRi CTA для определения молекулярной пригодности, и участники, соответствующие критериям молекулярной пригодности, будут иметь право на полный скрининг исследования. Участники, включенные в исследование (без предварительного лечения анти-PD- [L] 1 агентом), будут глотать таблетки эрдафитиниба перорально в начальной дозе 8 мг один раз в день в течение 21 дня в 21-дневном цикле до прогрессирования заболевания, непереносимая токсичность , отзыв согласия или решения исследователя о прекращении лечения. Корректировка дозы зависит от уровня фосфата и наблюдаемой токсичности (НЯ).

Метка: Когорта 2 (группа 2B): пембролизумаб

Тип: Экспериментальный

Описание: Участники будут подвергнуты скринингу на основе FGFRi CTA для определения молекулярной пригодности, и участники, соответствующие критериям молекулярной пригодности, будут иметь право на полный скрининг исследования. Участники, включенные в исследование (без предварительного лечения анти-PD- [L] 1 агентом), будут получать пембролизумаб 200 мг в виде 30-минутной внутривенной инфузии один раз каждые 3 недели до прогрессирования заболевания, недопустимой токсичности, отзыва согласия или решения следователь прекратил лечение. Корректировка дозы основана на наблюдаемой токсичности.

Информация о дизайне исследования

Распределение: Рандомизированный

Модель вмешательства: Параллельное присвоение

Первичное назначение: Уход

Маскировка: Нет (открытая этикетка)