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 renal function status on panobinostat PK.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
37
University of Utah / Huntsman Cancer Institute
Salt Lake City, Utah, United States
Novartis Investigative Site
Leiden, Netherlands
Novartis Investigative Site
Utrecht, Netherlands
Novartis Investigative Site
Sankt Gallen, Switzerland
Novartis Investigative Site
Merseyside, United Kingdom
To assess the effect of varying degrees of renal function as defined by creatinine clearance), on the pharmacokinetics of panobinostat.
Time frame: First 7 days
To assess the effect of varying degrees of renal function on the safety of panobinostat
Time frame: Entire duration of study
To evaluate whether there is a relationship between PK and safety parameters in patients with varying degrees of renal function.
Time frame: 7 days
To explore anti-tumor activity associated with panobinostat.
Time frame: 6 months (6 cycles)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.