Clinical trial · Interventional
An Experimental Study of Belzutifan Impact on Catecholamine Metabolism
An Experimental Pilot Study to Investigate Changes in Catecholamine Synthesis and Metabolism in Patients With Molecularly Profiled Phaeochromocytoma and Paraganglioma Taking Belzutifan
NCT07680205CI-TRIAL-00116710recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pheochromocytoma | Adrenal Gland Pheochromocytoma | ALIAS | 0.90 |
| Pheochromocytoma and Paraganglioma (PPGL) | — | UNRESOLVED | — |
| Pheochromocytoma Malignant | — | UNRESOLVED | — |
| Pheochromocytoma, Metastatic | Adrenal Gland Pheochromocytoma | CURATED_BROADER | 0.78 |
| Pheochromocytoma/Paraganglioma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Belzutifan | Drug | Belzutifan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- For 14 day study protocol, including five days of intervention with Belzutifan
- interventionNames
- Drug: Belzutifan
Primary outcomes (1)
- measure
- Tyrosine measurements
- timeFrame
- Baseline, day 5 and day 14
- description
- The quantitative change in the amino acid tyrosine from baseline to the end of the study intervention (day 5) and to the end of the study (day 14).
Secondary outcomes (1)
- measure
- Plasma metanephrine measurements
- timeFrame
- Baseline, day 5 and day 15
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Adult patients \> 18 years * Patients must have a biochemically confirmed diagnosis of a phaeochromocytoma or paraganglioma using plasma metanephrines or 24- hour urinary metanephrines and plasma or urinary metanephrines should be at least 1.5 times the upper limit of the normal reference range. * Female patients of child-bearing potential must have a negative serum pregnancy test result within 3 days before first administration of study drug * Able to provide informed consent Exclusion Criteria: * Has hypoxia, or requires intermittent supplemental oxygen, or requires chronic supplemental oxygen. * Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA), or coronary artery bypass graft surgery (CABG) ≤6 months from Day 1 of study drug administration, or New York Heart Association Class III or IV congestive heart failure. Medically controlled arrhythmia stable on medication is permitted. * Has a co-existing malignancy (in addition to PPGL) * Has a Hb \< 100g/dL * Is on medications which may interfere with belzutifan pharmacokinetics and that cannot be stopped for the duration of the study and for 7 days after the study period (everolimus, omeprazole, esomeprazole, Fluconazole, fluoxetine, Voriconazole, Sirolimus) * Has a known diagnosis of HIV, hepatitis B or hepatitis C
References
Publications (9)
- BACKGROUNDLenders 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. PMID 24893135
- BACKGROUNDTufton 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. PMID 27761935
- BACKGROUNDBuffet 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. PMID 32295730
- BACKGROUNDWinzeler 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. PMID 34870338
- BACKGROUNDWinzeler B, Challis BG, Casey RT. Precision Medicine in Phaeochromocytoma and Paraganglioma. J Pers Med. 2021 Nov 22;11(11):1239. doi: 10.3390/jpm11111239. PMID 34834591
- BACKGROUNDNazari 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. PMID 37944546
- BACKGROUNDGruber 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.