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Набира участници Фаза 2 NCT04924075

Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015)

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Pheochromocytoma/Paraganglioma Pancreatic Neuroendocrine Tumor Von Hippel-Lindau Disease Advanced Gastrointestinal Stromal Tumor HIF-2α Mutated Cancers

Спонсор: Merck Sharp & Dohme LLC

Налично на: БГ
Обобщение
This is a study to evaluate the efficacy and safety of belzutifan monotherapy in participants with advanced pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumor (pNET), von Hippel-Lindau (VHL) disease-associated tumors, advanced wt (wild-type) gastrointestinal stromal tumor (wt GIST), or advanced solid tumors with hypoxia inducible factor-2 alpha (HIF-2α) related genetic alterations. The primary objective of the study is to evaluate the objective response rate (ORR) of belzutifan per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR).
Кой може да участва
The main inclusion criteria include but are not limited to the following: * Male and female participants at least 12 years of age (at least 18 years of age for Cohort B1) * Diagnosis of one of the following: Advanced/metastatic pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumors (pNET), von Hippel-Lindau (VHL) disease associated localized tumors, or advanced wild-type gastrointestinal stromal tumor (wt GIST) or advanced solid tumors with Hypoxia Inducible Factor- 2 alpha subunit (HIF-2α) related genetic alterations * Cohort BI: VHL Disease-associated tumors: * Have a diagnosis of VHL disease as determined by a germline test locally and/or clinical diagnosis * Must be ≥18 years of age * Has a life expectancy of at least 3 months The main exclusion criteria include but are not limited to the following: * Unable to swallow orally administered medication or has a disorder that might affect the absorption of belzutifan * History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years * Any of the following: A pulse oximeter reading \<92% at rest, or requires intermittent supplemental oxygen, or requires chronic supplemental oxygen * Clinically significant cardiac disease, including unstable angina, acute myocardial infarction, or arterial bypass (CABG) or Percutaneous transluminal coronary angioplasty (PTCA) ≤6 months from study entry, or New York Heart Association Class III or IV congestive heart failure * Received prior treatment (except somatostatin analogs) with chemotherapy, targeted therapy, biologics, or other investigational therapy within the past 4 weeks of first dose of study intervention
Интервенции
Belzutifan
DRUG
Места на провеждане 84
Австралия (2)
The Royal Melbourne Hospital ( Site 1602)
Parkville , Victoria
Study Coordinator
Prince of Wales Hospital-Medical Oncology ( Site 1601)
Randwick , New South Wales
Study Coordinator
Канада (2)
Arthur J.E. Child Comprehensive Cancer Centre ( Site 0203)
Calgary , Alberta
Study Coordinator
Princess Margaret Cancer Centre ( Site 0202)
Toronto , Ontario
Study Coordinator
Chile (2)
FALP ( Site 2200)
Santiago , Region M. de Santiago
Study Coordinator
Centro de Oncología de Precisión ( Site 2203)
Santiago , Region M. de Santiago
Study Coordinator
Китай (4)
Peking University First Hospital-Urology ( Site 1900)
Beijing , Beijing Municipality
ACTIVE_NOT_RECRUITING
West China Hospital of Sichuan University ( Site 1906)
Chengdu , Sichuan
COMPLETED
Sun Yat-sen University Cancer Center ( Site 1905)
Guangzhou , Guangdong
Study Coordinator
Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 1904)
Shanghai , Shanghai Municipality
ACTIVE_NOT_RECRUITING
Дания (3)
Rigshospitalet ( Site 0304)
Copenhagen , Capital Region
Study Coordinator
Rigshospitalet-Department of Endocrinology ( Site 0303)
Copenhagen , Capital Region
Study Coordinator
Odense Universitetshospital ( Site 0302)
Odense , Region Syddanmark
Study Coordinator
Франция (6)
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0407)
Le Kremlin-Bicêtre , Paris
Study Coordinator
Hôpital Edouard Herriot-oncologie ( Site 0405)
Lyon , Auvergne-Rhône-Alpes
Study Coordinator
Institut Paoli-Calmettes-Oncology ( Site 0406)
Marseille , Bouches-du-Rhone
COMPLETED
Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0404)
Paris
Study Coordinator
CHU Strasbourg-Hautepierre-Medecine Interne, Endocrinologie et Nutrition ( Site 0402)
Strasbourg , Alsace
Study Coordinator
Gustave Roussy ( Site 0403)
Villejuif , Île-de-France Region
Study Coordinator
Германия (5)
Charité Universitaetsmedizin Berlin - Campus Mitte-Department of Endocrinology and Metabolism ( Site 0503)
Berlin
Study Coordinator
Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 0505)
Düsseldorf , North Rhine-Westphalia
Study Coordinator
Universitaetsklinikum Freiburg ( Site 0504)
Freiburg im Breisgau , Baden-Wurttemberg
Study Coordinator
Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Department of Internal Medicine IV, Division ( Site 0501)
München , Bavaria
COMPLETED
Comprehensive Cancer Center Mainfranken-Div. of Endocrinology and Diabetes ( Site 0500)
Würzburg , Bavaria
Study Coordinator
Унгария (1)
Semmelweis University-Belgyógyászati és Onkológiai Klinika Hematológia Osztály ( Site 0600)
Budapest
Study Coordinator
Израел (2)
Sheba Medical Center-Institute of Endocrinology, Diabetes and Metabolism ( Site 1400)
Ramat Gan
Study Coordinator
Sourasky Medical Center ( Site 1401)
Tel Aviv
Study Coordinator
Италия (8)
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 0708)
Bologna
Study Coordinator
Azienda Ospedaliera Spedali Civili di Brescia-Oncology ( Site 0701)
Brescia
Study Coordinator
Fondazione IRCCS Istituto Nazionale dei Tumori-S.C. Oncologia Medica 2- Sarcomi ( Site 0709)
Milan , Lombardy
Study Coordinator
Ospedale San Raffaele-Oncologia Medica ( Site 0705)
Milan
COMPLETED
Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Medica Gastrointestinale e Tumori Neuroe ( Site 0700)
Milan
Study Coordinator
University of Naples Federico II-Dipartimento di Medicina Clinica e Chirurgia ( Site 0704)
Naples , Campania
COMPLETED
Azienda Ospedaliero Universitaria Senese-U.O.C. Immunoterapia Oncologica ( Site 0706)
Siena , Tuscany
Study Coordinator
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma ( Site 0703)
Verona
Study Coordinator
Япония (6)
National Cancer Center Hospital ( Site 1802)
Chuo-ku , Tokyo
ACTIVE_NOT_RECRUITING
Kyoto University Hospital ( Site 1806)
Kyoto
ACTIVE_NOT_RECRUITING
Kochi Medical School Hospital ( Site 1807)
Nankoku , Kochi
ACTIVE_NOT_RECRUITING
Hokkaido University Hospital ( Site 1800)
Sapporo , Hokkaido
ACTIVE_NOT_RECRUITING
Tokyo Women's Medical University Adachi Medical Center ( Site 1803)
Tokyo
ACTIVE_NOT_RECRUITING
Yokohama City University Hospital ( Site 1804)
Yokohama , Kanagawa
ACTIVE_NOT_RECRUITING
Нидерландия (1)
Universitair Medisch Centrum Utrecht ( Site 1530)
Utrecht
Study Coordinator
Норвегия (1)
Oslo Universitetssykehus Radiumhospitalet ( Site 2400)
Oslo
Study Coordinator
Португалия (2)
START Lisbon - Hospital de Santa Maria ( Site 2601)
Lisbon , Lisbon District
Study Coordinator
Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E. ( Site 2600)
Porto
Study Coordinator
Russia (5)
Fed State Budgetary Inst N.N. Blokhin Med Center of Oncology MHRF ( Site 0801)
Moscow , Moscow
Study Coordinator
Endocrinology Research Center of Rosmedtechnologies-Surgery ( Site 0809)
Moscow , Moscow
COMPLETED
Saint Petersburg State University-Clinic of advanced medical technologies n. a. Nicolay I. Pirogov ( Site 0805)
Saint Petersburg , Leningradskaya Oblast'
COMPLETED
Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 0803)
Saint Petersburg , Leningradskaya Oblast'
Study Coordinator
GBUZ Republican Clinical Oncological Dispensary ( Site 0804)
Ufa , Baskortostan, Respublika
COMPLETED
Сингапур (1)
National Cancer Centre Singapore ( Site 1700)
Singapore , Central Singapore
Study Coordinator
Южна Корея (2)
Seoul National University Hospital ( Site 2001)
Jongno-gu , Seoul
Study Coordinator
Asan Medical Center ( Site 2000)
Songpa-gu , Seoul
Study Coordinator
Испания (4)
Hospital Universitari Vall d'Hebron ( Site 1100)
Barcelona
Study Coordinator
MD Anderson Cancer Center-Oncology ( Site 1102)
Madrid , Madrid, Comunidad de
COMPLETED
Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1103)
Madrid , Madrid, Comunidad de
Study Coordinator
Hospital Universitario Central de Asturias-Medical Oncology ( Site 1101)
Oviedo , Principality of Asturias
Study Coordinator
Швеция (4)
Sahlgrenska Universitetssjukhuset-Department of Oncology CTU Clinical Trial Unit ( Site 1204)
Gothenburg , Västra Götaland County
Study Coordinator
Skanes University Hospital Lund ( Site 1200)
Lund , Skåne County
Study Coordinator
Karolinska Universitetssjukhuset Solna ( Site 1202)
Stockholm , Stockholm County
COMPLETED
Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1201)
Uppsala , Uppsala County
Study Coordinator
Турция (5)
Hacettepe Universitesi-oncology hospital ( Site 0901)
Ankara
Study Coordinator
Ankara Bilkent Şehir Hastanesi. ( Site 0904)
Ankara
Study Coordinator
Ege University Medicine of Faculty ( Site 0900)
Bornova , İzmir
Study Coordinator
Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 0902)
Istanbul
COMPLETED
Baskent University Adana Training Hospital ( Site 0906)
Yüreğir , Adana
Study Coordinator
Великобритания (4)
Addenbrooke's Hospital ( Site 1309)
Cambridge , Cambridgeshire
Study Coordinator
The Beatson West of Scotland Cancer Centre ( Site 1308)
Glasgow , Glasgow City
Study Coordinator
Hammersmith Hospital-Medical Oncology ( Site 1304)
London , London, City of
Study Coordinator
Royal Free Hospital ( Site 1302)
London , England
COMPLETED
САЩ (14)
University of Michigan ( Site 0126)
Ann Arbor , Michigan
Study Coordinator
Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Developmental Therapeutics ( Site 0108)
Baltimore , Maryland
Study Coordinator
National Institutes of Health ( Site 0125)
Bethesda , Maryland
Study Coordinator
Massachusetts General Hospital ( Site 0111)
Boston , Massachusetts
Study Coordinator
Northwestern University - Robert H. Lurie Comprehensive Cancer Center ( Site 0130)
Chicago , Illinois
Study Coordinator
University of Texas MD Anderson Cancer Center ( Site 0112)
Houston , Texas
Study Coordinator
University of Iowa ( Site 0104)
Iowa City , Iowa
Study Coordinator
Cedars-Sinai Medical Center ( Site 0110)
Los Angeles , California
Study Coordinator
SCRI Oncology Partners ( Site 7000)
Nashville , Tennessee
Study Coordinator
Vanderbilt University Medical Center ( Site 0107)
Nashville , Tennessee
Study Coordinator
Icahn School of Medicine at Mount Sinai ( Site 0123)
New York , New York
ACTIVE_NOT_RECRUITING
Penn Medicine: University of Pennsylvania Health System-Heme/Onc ( Site 0127)
Philadelphia , Pennsylvania
Study Coordinator
Washington University-Internal Medicine/Oncology ( Site 0124)
St Louis , Missouri
ACTIVE_NOT_RECRUITING
Northwestern Medicine Cancer Center - Warrenville ( Site 0134)
Warrenville , Illinois
Study Coordinator
Технически детайли
Статус
Набира участници
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
12 Years
Здрави доброволци
Не
Начална дата
12.08.2021
Крайна дата
04.06.2029
Регистрационен номер
NCT04924075
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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