Clinical Trial

Pharmacokinetics and Safety Study of Pelabresib in Patients With Advanced Malignancies and Hepatic Impairment

Recruiting Phase 1
View on ClinicalTrials.gov →
Summary
The primary purpose of this study is to evaluate the impact of hepatic function on the pharmacokinetic (PK) profile of pelabresib in participants with advanced malignancies who have either hepatic impairment (HI) or normal liver function. To reduce participant burden and maximize benefit, the PK of pelabresib will be assessed at steady-state rather than after a single dose, avoiding treatment-free washout periods.
Protocol Amendment History 4 changes
notable Trial sites expanded: 2 -> 5 locations 2026-06-09
critical Recruitment opened 2026-05-12
notable Primary completion moved earlier: 2028-07-31 -> 2028-06-28 2026-05-12
minor Completion moved earlier: 2028-09-04 -> 2028-08-02 2026-05-12
Trial Details
NCT Number NCT07422610
Lead Sponsor Novartis Pharmaceuticals
Conditions Advanced Malignancies and Hepatic Impairment
Enrollment 24 participants
Start Date 2026-04-24
Primary Completion 2028-06-28 (estimated)
Study Completion 2028-08-02 (estimated)
Updated on ClinicalTrials.gov 2026-07-08