Belzutifan and catecholamine metabolism in pheochromocytoma/paraganglioma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm, pilot interventional study conducted at Cambridge University Hospitals to see if Belzutifan at 120 mg daily for five days alters catecholamine synthesis and metabolism. Researchers will measure baseline and subsequent levels of tyrosine and catecholamine metabolites to understand the drug’s metabolic effects. The protocol plans 14 days of participation for each patient, with careful genetic data collection as part of routine care.

Why it matters

Who can join: the full rules

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

Where it's running

• Cambridge University Hospitals NHS Foundation Trust
  Cambridge, Cambridgeshire, United Kingdom Recruiting

Study contacts

• Principal investigator: Ruth T Casey, MD PhD — Cambridge University Hospital and University of Cambridge
• Study coordinator: August Palma Senior Research Nurse - Endocrinology
• Email: august.palma@nhs.net
• Phone: 01223 217 848

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.