Pharmacokinetics and Safety of Panobinostat in Patients With Advanced Solid Tumors and Various Degrees of Hepatic Function

Completed · Phase 1

Conditions studied: Advanced Solid Tumors

In brief

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.

Key facts

Study ID

NCT01007968

Run by

Novartis Pharmaceuticals

People needed

25

Starts

2010-03-01

Expected to finish

2012-11-01

Last updated by the study team

2020-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient has documented diagnosis of advanced solid tumor for which no standard systemic therapy exists
• Patient has normal or abnormal hepatic organ function
• Patient has provided written informed consent prior to any screening procedures

You may not qualify if…

• Patient needing valproic acid for any medical condition during the study or within 5 days prior to the first panobinostat dose
• Patient received prior treatment with DAC inhibitors including panobinostat
• Patient requires treatment with warfarin that cannot be switched to another anticoagulant treatment prior to starting study drug
• Patient has encephalopathy
• Patient has ascites requiring intervention
• Female patient who is pregnant or breast feeding or with childbearing potential and not willing to use a double method of contraception up to 3 months after the end of study treatment. Male patient who is not willing to use a barrier method of contraception up to 3 months after the end of study treatment.
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• 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

Full record on ClinicalTrials.gov

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