Phase
Condition
Neoplasms
Neuroendocrine Carcinoma
Solid Tumors
Treatment
Belzutifan
Clinical Study ID
Ages > 12 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
Study Design
Connect with a study center
Prince of Wales Hospital-Medical Oncology ( Site 1601)
Randwick, New South Wales 2031
AustraliaActive - Recruiting
The Royal Melbourne Hospital ( Site 1602)
Parkville, Victoria 3050
AustraliaActive - Recruiting
Arthur J.E. Child Comprehensive Cancer Centre ( Site 0203)
Calgary, Alberta T2N 5G2
CanadaActive - Recruiting
Tom Baker Cancer Center ( Site 0203)
Calgary, Alberta T2N 4N2
CanadaActive - Recruiting
Princess Margaret Cancer Centre ( Site 0202)
Toronto, Ontario M5G 2M9
CanadaActive - Recruiting
Centro de Oncología de Precisión ( Site 2203)
Santiago, Region M. De Santiago 7560908
ChileActive - Recruiting
FALP ( Site 2200)
Santiago, Region M. De Santiago 7500921
ChileActive - Recruiting
Peking University First Hospital-Urology ( Site 1900)
Beijing, Beijing 100034
ChinaSite Not Available
Sun Yat-sen University Cancer Center ( Site 1905)
Guangzhou, Guangdong 510700
ChinaActive - Recruiting
Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 1904)
Shanghai, Shanghai 200001
ChinaSite Not Available
West China Hospital of Sichuan University ( Site 1906)
Cheng Du, Sichuan 610041
ChinaCompleted
Rigshospitalet ( Site 0304)
Copenhagen, Hovedstaden 2100
DenmarkActive - Recruiting
Rigshospitalet-Department of Endocrinology ( Site 0303)
Copenhagen, Hovedstaden 2100
DenmarkActive - Recruiting
Odense Universitetshospital ( Site 0302)
Odense, Syddanmark 5000
DenmarkSite Not Available
Odense Universitetshospital ( Site 0302)
Odense C, Syddanmark 5000
DenmarkActive - Recruiting
CHU Strasbourg-Hautepierre-Medecine Interne, Endocrinologie et Nutrition ( Site 0402)
Strasbourg, Alsace 67098
FranceActive - Recruiting
Institut Paoli-Calmettes-Oncology ( Site 0406)
Marseille, Bouches-du-Rhone 13009
FranceSite Not Available
Gustave Roussy ( Site 0403)
Villejuif, Ile-de-France 94805
FranceActive - Recruiting
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0407)
Le Kremlin-Bicêtre, Paris 94270
FranceActive - Recruiting
Hôpital Edouard Herriot-oncologie ( Site 0405)
Lyon, Rhone-Alpes 69003
FranceActive - Recruiting
Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0404)
Paris, 75014
FranceActive - Recruiting
Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Department of Internal Medicine IV, Division (
München, Bayern 80336
GermanyCompleted
Comprehensive Cancer Center Mainfranken-Div. of Endocrinology and Diabetes ( Site 0500)
Würzburg, Bayern 97080
GermanyActive - Recruiting
Universitaetsklinikum Freiburg ( Site 0504)
Freiburg, Brandenburg 79106
GermanyActive - Recruiting
Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 0505)
Düsseldorf, Nordrhein-Westfalen 40225
GermanyActive - Recruiting
Charité Universitaetsmedizin Berlin - Campus Mitte-Department of Endocrinology and Metabolism ( Site
Berlin, 10117
GermanyActive - Recruiting
Semmelweis University-Belgyógyászati és Onkológiai Klinika Hematológia Osztály ( Site 0600)
Budapest, 1083
HungaryActive - Recruiting
Sheba Medical Center-Institute of Endocrinology, Diabetes and Metabolism ( Site 1400)
Ramat Gan, 5262100
IsraelActive - Recruiting
Sourasky Medical Center ( Site 1401)
Tel Aviv, 6423906
IsraelActive - Recruiting
University of Naples Federico II-Dipartimento di Medicina Clinica e Chirurgia ( Site 0704)
Naples, Campania 80100
ItalyCompleted
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 0708)
Bologna, 40138
ItalyActive - Recruiting
Azienda Ospedaliera Spedali Civili di Brescia-Oncology ( Site 0701)
Brescia, 25123
ItalyActive - Recruiting
Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Medica Gastrointestinale e Tumori Neuroe
Milano, 20141
ItalyActive - Recruiting
Ospedale San Raffaele-Oncologia Medica ( Site 0705)
Milano, 20132
ItalyCompleted
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma ( Site 0703)
Verona, 37134
ItalyActive - Recruiting
Hokkaido University Hospital ( Site 1800)
Sapporo, Hokkaido 060-8648
JapanSite Not Available
Yokohama City University Hospital-Department of Urology ( Site 1804)
Yokohama, Kanagawa 2360004
JapanSite Not Available
Yokohama City University Hospital ( Site 1804)
Yokohama-shi, Kanagawa 236-0004
JapanSite Not Available
Kochi Medical School Hospital ( Site 1807)
Nankoku, Kochi 783-8505
JapanSite Not Available
National Cancer Center Hospital ( Site 1802)
Chuo-ku, Tokyo 104-0045
JapanSite Not Available
Kyoto University Hospital ( Site 1806)
Kyoto,
JapanSite Not Available
Tokyo Women's Medical University Adachi Medical Center ( Site 1803)
Tokyo, 123-8558
JapanSite Not Available
Seoul National University Hospital ( Site 2001)
Jongno-gu, Seoul 03080
Korea, Republic ofActive - Recruiting
Asan Medical Center ( Site 2000)
Songpa-gu, Seoul 05505
Korea, Republic ofActive - Recruiting
Universitair Medisch Centrum Utrecht ( Site 1530)
Utrecht, 3584 CX
NetherlandsActive - Recruiting
Oslo Universitetssykehus Radiumhospitalet ( Site 2400)
Oslo, 0424
NorwayActive - Recruiting
GBUZ Republican Clinical Oncological Dispensary ( Site 0804)
Ufa, Baskortostan, Respublika 450054
Russian FederationSuspended
Saint Petersburg State University-Clinic of advanced medical technologies n. a. Nicolay I. Pirogov (
Saint Petersburg, Leningradskaya Oblast 190020
Russian FederationCompleted
Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 0803)
Saint Petersburg, Leningradskaya Oblast 198255
Russian FederationSuspended
Endocrinology Research Center of Rosmedtechnologies-Surgery ( Site 0809)
Moscow, Moskva 117036
Russian FederationCompleted
Fed State Budgetary Inst N.N. Blokhin Med Center of Oncology MHRF ( Site 0801)
Moscow, Moskva 115522
Russian FederationSuspended
National Cancer Centre Singapore ( Site 1700)
Singapore, Central Singapore 168583
SingaporeActive - Recruiting
Hospital Universitario Central de Asturias-Medical Oncology ( Site 1101)
Oviedo, Asturias 33011
SpainActive - Recruiting
Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1103)
Madrid, Madrid, Comunidad De 28041
SpainActive - Recruiting
MD Anderson Cancer Center-Oncology ( Site 1102)
Madrid, Madrid, Comunidad De 28033
SpainCompleted
Hospital Universitari Vall d'Hebron ( Site 1100)
Barcelona, 08035
SpainActive - Recruiting
Skanes University Hospital Lund ( Site 1200)
Lund, Skane Lan 221 85
SwedenActive - Recruiting
Karolinska Universitetssjukhuset Solna ( Site 1202)
Stockholm, Stockholms Lan 171 76
SwedenCompleted
Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1201)
Uppsala, Uppsala Lan 751 85
SwedenActive - Recruiting
Sahlgrenska Universitetssjukhuset-Department of Oncology CTU Clinical Trial Unit ( Site 1204)
Gothenburg, Vastra Gotalands Lan 413 45
SwedenActive - Recruiting
Baskent University Adana Training Hospital ( Site 0906)
Yuregir, Adana 01250
TurkeyActive - Recruiting
Baskent University Adana Training Hospital ( Site 0906)
Yüregir, Adana 01250
TurkeySite Not Available
Ege University Medicine of Faculty ( Site 0900)
Bornova, Izmir 35100
TurkeyActive - Recruiting
Ankara Bilkent Şehir Hastanesi. ( Site 0904)
Ankara, 06800
TurkeyActive - Recruiting
Ankara City Hospital ( Site 0904)
Ankara, 06800
TurkeyActive - Recruiting
Hacettepe Universitesi-oncology hospital ( Site 0901)
Ankara, 06230
TurkeyActive - Recruiting
Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 0902)
Istanbul, 34668
TurkeyCompleted
Ege University-Tulay Aktas Oncology Department ( Site 0900)
Izmir, 35100
TurkeySite Not Available
Addenbrooke's Hospital ( Site 1309)
Cambridge, Cambridgeshire CB2 2QQ
United KingdomActive - Recruiting
Royal Free Hospital ( Site 1302)
London, England NW3 2QG
United KingdomSite Not Available
The Beatson West of Scotland Cancer Centre ( Site 1308)
Glasgow, Glasgow City G12 0YN
United KingdomActive - Recruiting
Hammersmith Hospital-Medical Oncology ( Site 1304)
London, London, City Of W12 OHS
United KingdomActive - Recruiting
Cedars-Sinai Medical Center ( Site 0110)
Los Angeles, California 90048
United StatesActive - Recruiting
Northwestern University - Robert H. Lurie Comprehensive Cancer Center ( Site 0130)
Chicago, Illinois 60611
United StatesActive - Recruiting
University of Iowa ( Site 0104)
Iowa City, Iowa 52242
United StatesActive - Recruiting
Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Developmental Therapeutics ( Site
Baltimore, Maryland 21287
United StatesActive - Recruiting
National Institute of Health ( Site 0125)
Bethesda, Maryland 20892
United StatesActive - Recruiting
National Institutes of Health ( Site 0125)
Bethesda, Maryland 20892
United StatesActive - Recruiting
Massachusetts General Hospital ( Site 0111)
Boston, Massachusetts 02114
United StatesActive - Recruiting
University of Michigan ( Site 0126)
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
Washington University-Internal Medicine/Oncology ( Site 0124)
Saint Louis, Missouri 63110
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai ( Site 0123)
New York, New York 10029
United StatesSite Not Available
Penn Medicine: University of Pennsylvania Health System-Heme/Onc ( Site 0127)
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
SCRI Oncology Partners ( Site 7000)
Nashville, Tennessee 37203
United StatesActive - Recruiting
Vanderbilt University Medical Center ( Site 0107)
Nashville, Tennessee 37232
United StatesActive - Recruiting
University of Texas MD Anderson Cancer Center ( Site 0112)
Houston, Texas 77030
United StatesActive - Recruiting
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