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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
25
University of Utah / Huntsman Cancer Institute
Salt Lake City, Utah, United States
Novartis Investigative Site
Leiden, Netherlands
Novartis Investigative Site
Lund, Sweden
Novartis Investigative Site
Stockholm, Sweden
Novartis Investigative Site
Sankt Gallen, Switzerland
Novartis Investigative Site
Edinburgh, United Kingdom
To assess the effect of various degrees of impairment in hepatic function as measured by the National Cancer Institute-Cancer Therapy Evaluation Program (NCI-CTEP) criteria, on the pharmacokinetics of panobinostat.
Time frame: first 7 days
To assess the effect of various degrees of impairment in hepatic function on the safety of panobinostat
Time frame: entire duration of study
To evaluate whether there is a relationship between panobinostat PK and safety parameters in patients with various degrees of hepatic organ function
Time frame: first 7 days
To explore anti-tumor activity associated with panobinostat.
Time frame: best overall response
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