A Phase 1b, open-label, multicenter study to evaluate the pharmacokinetic profile of Pelabresib (DAK539/CPI‑0610) in patients with advanced cancer and hepatic impairment.
Principal Investigator
Dott.ssa Vanesa Gregorc
Contact Information for Access
- vanesa.gregorc@inoc.it
- chiara.lazzari@inoc.it
- alessio.polidori@inoc.it
- martina.danzero@inoc.it
- ufficio.trials@inoc.it
Phase
FASE I
Status
ATTIVO
Objective of the study
- To evaluate the impact of hepatic function on the steady-state pharmacokinetic profile of pelabresib in participants with advanced cancer and hepatic impairment or normal hepatic function (according to NCI-ODWG criteria).
- Investigate additional pharmacokinetic parameters of pelabresib in participants with advanced cancer and hepatic impairment or normal liver function.
- Evaluate the safety and tolerability of pelabresib in participants with advanced cancer and hepatic impairment or normal liver function.
Solid tumors that have exhausted standard of care.
ClinicalTrials.gov ID NCT07422610
Sponsor: Novartis Pharmaceuticals
https://euclinicaltrials.eu/ctis-public/view/2025-521001-40-00
Pathologies
Multiple oncological conditions , Onco-hematological (hematological cancers/malignancies)
Medication
Palabresib
Who is eligible to participate in the study?
Patients between the ages of 18 and 75 with liver impairment and a diagnosis of advanced-stage cancer for which no standard of care and/or curative treatment option is available.
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