Идёт набор 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)
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Belzutifan.
- Кому может быть актуально
- Состояния в реестре: Pheochromocytoma/Paraganglioma, Pancreatic Neuroendocrine Tumor, Von Hippel-Lindau Disease, Advanced Gastrointestinal Stromal Tumor. Базовые параметры: от 12 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США, Австралия, Канада, Чили, Китай +17
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Phase 2 Study to Evaluate the Efficacy and Safety of Belzutifan (MK-6482, Formerly PT2977) Monotherapy in Participants With Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Advanced Solid Tumors With HIF-2α Related Genetic Alterations
Обзор
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).
Вмешательства
- Препарат Belzutifan
Belzutifan, 120 mg, oral, once daily (QD) until progressive disease or discontinuation.
Первичные конечные точки
- Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR) [Срок оценки: Up to approximately 5.5 years]
Вторичные конечные точки (8)
- Duration of Response (DOR) as Assessed by BICR [Срок оценки: Up to approximately 5.5 years]
- Time to Response (TTR) as Assessed by BICR [Срок оценки: Up to approximately 5.5 years]
- Disease Control Rate (DCR) as Assessed by BICR [Срок оценки: Up to approximately 5.5 years]
- Progressive Free Survival (PFS) as Assessed by BICR [Срок оценки: Up to approximately 5.5 years]
- Overall Survival (OS) [Срок оценки: Up to approximately 5.5 years]
- Number of Participants Who Experience an Adverse Event (AE) [Срок оценки: Up to approximately 5.5 years]
- Number of Participants Who Discontinue Study Treatment Due to an AE [Срок оценки: Up to approximately 5.5 years]
- Time to Surgery (TTS) [Срок оценки: Up to approximately 5.5 years]
Критерии участия
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 B1: 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 14 центров
- Cedars-Sinai Medical Center ( Site 0110) — Los Angeles
- Northwestern University - Robert H. Lurie Comprehensive Cancer Center ( Site 0130) — Chicago
- Northwestern Medicine Cancer Center - Warrenville ( Site 0134) — Warrenville
- University of Iowa ( Site 0104) — Iowa City
- Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Developmental Therapeut — Baltimore
- National Institutes of Health ( Site 0125) — Bethesda
- Massachusetts General Hospital ( Site 0111) — Boston
- University of Michigan ( Site 0126) — Ann Arbor
- … и ещё 6 центров
Италия · 8 центров
- University of Naples Federico II-Dipartimento di Medicina Clinica e Chirurgia ( Site 0704) — Naples
- Fondazione IRCCS Istituto Nazionale dei Tumori-S.C. Oncologia Medica 2- Sarcomi ( Site 070 — Milan
- Azienda Ospedaliero Universitaria Senese-U.O.C. Immunoterapia Oncologica ( Site 0706) — Siena
- IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 0708 — Bologna
- Azienda Ospedaliera Spedali Civili di Brescia-Oncology ( Site 0701) — Brescia
- Ospedale San Raffaele-Oncologia Medica ( Site 0705) — Milan
- Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Medica Gastrointestinale e Tumo — Milan
- Centro Ricerche Cliniche di Verona ( Site 0703) — Verona
Франция · 6 центров
- CHU Strasbourg-Hautepierre-Medecine Interne, Endocrinologie et Nutrition ( Site 0402) — Strasbourg
- Hôpital Edouard Herriot-oncologie ( Site 0405) — Lyon
- Institut Paoli-Calmettes-Oncology ( Site 0406) — Marseille
- Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0407) — Le Kremlin-Bicêtre
- Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0404) — Paris
- Gustave Roussy ( Site 0403) — Villejuif
Япония · 6 центров
- Hokkaido University Hospital ( Site 1800) — Sapporo
- Yokohama City University Hospital ( Site 1804) — Yokohama
- Kochi Medical School Hospital ( Site 1807) — Nankoku
- National Cancer Center Hospital ( Site 1802) — Chuo-ku
- Kyoto University Hospital ( Site 1806) — Kyoto
- Tokyo Women's Medical University Adachi Medical Center ( Site 1803) — Tokyo
Германия · 5 центров
- Universitaetsklinikum Freiburg ( Site 0504) — Freiburg im Breisgau
- Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Department of Internal Medicine IV, — München
- Comprehensive Cancer Center Mainfranken-Div. of Endocrinology and Diabetes ( Site 0500) — Würzburg
- Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 050 — Düsseldorf
- Charité Universitaetsmedizin Berlin - Campus Mitte-Department of Endocrinology and Metabol — Berlin
Россия · 5 центров
- GBUZ Republican Clinical Oncological Dispensary ( Site 0804) — Ufa
- Saint Petersburg State University-Clinic of advanced medical technologies n. a. Nicolay I. — Saint Petersburg
- Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 0803) — Saint Petersburg
- Fed State Budgetary Inst N.N. Blokhin Med Center of Oncology MHRF ( Site 0801) — Moscow
- Endocrinology Research Center of Rosmedtechnologies-Surgery ( Site 0809) — Moscow
Turkey (Türkiye) · 5 центров
- Baskent University Adana Training Hospital ( Site 0906) — Yüreğir
- Ege University Medicine of Faculty ( Site 0900) — Bornova
- Hacettepe Universitesi-oncology hospital ( Site 0901) — Ankara
- Ankara Bilkent Şehir Hastanesi. ( Site 0904) — Ankara
- Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 0902) — Istanbul
Китай · 4 центра
- Peking University First Hospital-Urology ( Site 1900) — Пекин
- Sun Yat-sen University Cancer Center ( Site 1905) — Гуанчжоу
- Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 1904) — Шанхай
- West China Hospital of Sichuan University ( Site 1906) — Чэнду
Испания · 4 центра
- MD Anderson Cancer Center-Oncology ( Site 1102) — Madrid
- Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1103) — Madrid
- Hospital Universitario Central de Asturias-Medical Oncology ( Site 1101) — Oviedo
- Hospital Universitari Vall d'Hebron ( Site 1100) — Barcelona
Швеция · 4 центра
- Skanes University Hospital Lund ( Site 1200) — Lund
- Karolinska Universitetssjukhuset Solna ( Site 1202) — Stockholm
- Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1201) — Uppsala
- Sahlgrenska Universitetssjukhuset-Department of Oncology CTU Clinical Trial Unit ( Site 12 — Gothenburg
Великобритания · 4 центра
Список центров уточняется — проверьте первичный протокол.
Дания · 3 центра
- Rigshospitalet ( Site 0304) — Copenhagen
- Rigshospitalet-Department of Endocrinology ( Site 0303) — Copenhagen
- Odense Universitetshospital ( Site 0302) — Odense
Австралия · 2 центра
- Prince of Wales Hospital-Medical Oncology ( Site 1601) — Randwick
- The Royal Melbourne Hospital ( Site 1602) — Parkville
Канада · 2 центра
- Arthur J.E. Child Comprehensive Cancer Centre ( Site 0203) — Calgary
- Princess Margaret Cancer Centre ( Site 0202) — Toronto
Чили · 2 центра
- FALP ( Site 2200) — Santiago
- Centro de Oncología de Precisión ( Site 2203) — Santiago
Израиль · 2 центра
- Sheba Medical Center-Institute of Endocrinology, Diabetes and Metabolism ( Site 1400) — Ramat Gan
- Sourasky Medical Center ( Site 1401) — Tel Aviv
Португалия · 2 центра
- START Lisbon - Hospital de Santa Maria ( Site 2601) — Lisbon
- Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E. ( Site 2600) — Porto
South Korea · 2 центра
- Seoul National University Hospital ( Site 2001) — Jongno-gu
- Asan Medical Center ( Site 2000) — Songpa-gu
Венгрия · 1 центр
- Semmelweis University-Belgyógyászati és Onkológiai Klinika Hematológia Osztály ( Site 0600 — Budapest
Нидерланды · 1 центр
- Universitair Medisch Centrum Utrecht ( Site 1530) — Utrecht
Норвегия · 1 центр
- Oslo Universitetssykehus Radiumhospitalet ( Site 2400) — Oslo
Сингапур · 1 центр
- National Cancer Centre Singapore ( Site 1700) — Singapore
Публикации
- Jimenez C, Andreassen M, Durand A, Moog S, Hendifar A, Welin S, Spada F, Sharma R, Wolin E, Ruether J, Garcia-Carbonero R, Fassnacht M, Capdevila J, Del Rivero J, Iliopoulos O, Huillard O, Jang R, Mai K, Artamonova E, Hallqvist A, Else T, Odeleye-Ajakaye A, Gozman A, Naik GS, Berruti A; LITESPARK-015 Investigators. Belzutifan for Advanced Pheochromocytoma or Paraganglioma. N Engl J Med. 2025 Nov 2 PMID 41124218
Идентификаторы
NCT: NCT04924075 · 6482-015 · MK-6482-015 · PT2977 · jRCT2011220024 · 2023-504853-11-00 · 2020-005028-13