Pharmacokinetics and Safety of Panobinostat in Patients With Advanced Solid Tumors and Various Degrees of Hepatic Function
Status:
Completed
Trial end date:
2012-11-01
Target enrollment:
Participant gender:
Summary
Panobinostat (LBH589) is a deacetylase inhibitor (DACi) which belongs to a structurally novel
cinnamic hydroxamic acid class of compounds. It is one of the most potent class I/II pan-DAC
inhibitor (pan-DACi) that has shown anti-tumor activity in pre-clinical models and patients
with solid tumors and hematological malignancies.
To date, the pharmacokinetics (PK) of panobinostat has been characterized in patients with
solid tumors and hematological malignancies participating in several phase I/II clinical
studies. Panobinostat PK does not appear to be different in patients with solid tumors and
hematological malignancies. However, the effect of organ dysfunction on PK of panobinostat is
yet to be elucidated.
Kidney and liver are involved in the elimination and metabolism of panobinostat. The current
study is designed to evaluate the impact of hepatic function status on panobinostat PK.