drugset / Trial / NCT07680205
An Experimental Study of Belzutifan Impact on Catecholamine Metabolism
Phase 2
Recruiting
12 enrolled
Cambridge University Hospitals NHS Foundation Trust
University of Cambridge · collab
NaSingle-groupOpen-labelTreatment
Summary
To investigate the impact of a medication called Belzutifan on the production and subsequent metabolism of adrenaline and noradrenaline collectively termed 'catecholamines'. The study aims to identify changes in the production and metabolism of catecholamines by measuring the substance which starts the chain of catecholamine metabolism called tyrosine in patients before, during and after 5 days of taking Belzutifan 120mg daily.
Timeline
- Start
- 2026-04-27
- Primary completion
- 2027-04
- Completion
- 2027-12
Publications
- Background Lenders JW, Duh QY, Eisenhofer G, Gimenez-Roqueplo AP, Grebe SK, Murad MH, Naruse M, Pacak K, Young WF Jr; Endocrine Society. Pheochromocytoma and paraganglioma: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2014 Jun;99(6):1915-42. doi: 10.1210/jc.2014-1498.
- Background Tufton N, Gunganah K, Hussain S, Druce M, Carpenter R, Ashby M, Drake WM, Akker SA. Alpha blockade-not to be underdone. Clin Endocrinol (Oxf). 2017 Feb;86(2):306-308. doi: 10.1111/cen.13262. Epub 2016 Nov 21. No abstract available.
- Background Buffet A, Burnichon N, Favier J, Gimenez-Roqueplo AP. An overview of 20 years of genetic studies in pheochromocytoma and paraganglioma. Best Pract Res Clin Endocrinol Metab. 2020 Mar;34(2):101416. doi: 10.1016/j.beem.2020.101416. Epub 2020 Mar 10.
- Background Winzeler B, Tufton N, S Lim E, Challis BG, Park SM, Izatt L, Carroll PV, Velusamy A, Hulse T, Whitelaw BC, Martin E, Rodger F, Maranian M, Clark GR, A Akker S, Maher ER, Casey RT. Investigating the role of somatic sequencing platforms for phaeochromocytoma and paraganglioma in a large UK cohort. Clin Endocrinol (Oxf). 2022 Oct;97(4):448-459. doi: 10.1111/cen.14639. Epub 2021 Dec 6.
- Background Winzeler B, Challis BG, Casey RT. Precision Medicine in Phaeochromocytoma and Paraganglioma. J Pers Med. 2021 Nov 22;11(11):1239. doi: 10.3390/jpm11111239.
- Background Nazari MA, Hasan R, Haigney M, Maghsoudi A, Lenders JWM, Carey RM, Pacak K. Catecholamine-induced hypertensive crises: current insights and management. Lancet Diabetes Endocrinol. 2023 Dec;11(12):942-954. doi: 10.1016/S2213-8587(23)00256-5. Epub 2023 Nov 6.
- Background Gruber LM, Jasim S, Ducharme-Smith A, Weingarten T, Young WF, Bancos I. The Role for Metyrosine in the Treatment of Patients With Pheochromocytoma and Paraganglioma. J Clin Endocrinol Metab. 2021 May 13;106(6):e2393-e2401. doi: 10.1210/clinem/dgab130.
- Background Casey RT, Challis BG, Pitfield D, Mahroof RM, Jamieson N, Bhagra CJ, Vuylsteke A, Pettit SJ, Chatterjee KC. Management of an acute catecholamine-induced cardiomyopathy and circulatory collapse: a multidisciplinary approach. Endocrinol Diabetes Metab Case Rep. 2017 Nov 9;2017:17-0122. doi: 10.1530/EDM-17-0122. eCollection 2017.
- Background Alkaissi H, Nazari MA, Hadrava Vanova K, Uher O, Gordon CM, Talvacchio S, Diachenko N, Mukvich O, Wang H, Glod J, Zhuang Z, Pacak K. Rapid Cardiovascular Response to Belzutifan in HIF2A-Mediated Paraganglioma. N Engl J Med. 2024 Oct 24;391(16):1552-1555. doi: 10.1056/NEJMc2409427. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Belzutifan | Small molecule | 120 mg | — |