NCT07680205 An Experimental Study of Belzutifan Impact on Catecholamine Metabolism
| NCT ID | NCT07680205 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Cambridge University Hospitals NHS Foundation Trust |
| Condition | Pheochromocytoma and Paraganglioma (PPGL) |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2026-04-27 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 12 participants in total. It began in 2026-04-27 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Ruth T Casey, MD PhD
PRINCIPAL INVESTIGATOR
Cambridge University Hospital and University of Cambridge
Frequently Asked Questions
Who can join the NCT07680205 clinical trial?
This trial is open to participants of all sexes, studying Pheochromocytoma and Paraganglioma (PPGL). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07680205 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07680205 currently recruiting?
Yes, NCT07680205 is actively recruiting participants. Contact the research team at august.palma@nhs.net for enrollment information.
Where is the NCT07680205 trial being conducted?
This trial is being conducted at Cambridge, United Kingdom.
Who is sponsoring the NCT07680205 clinical trial?
NCT07680205 is sponsored by Cambridge University Hospitals NHS Foundation Trust. The principal investigator is Ruth T Casey, MD PhD at Cambridge University Hospital and University of Cambridge. The trial plans to enroll 12 participants.