Study to Evaluate Panobinostat (DACi) Pharmacokinetics and Safety in Solid Tumors and Varying Renal 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 renal function status on panobinostat PK.

Key facts

Study ID

NCT00997399

Run by

Novartis Pharmaceuticals

People needed

37

Starts

2010-03-01

Expected to finish

2014-06-01

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 renal 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 requiring dialysis
• Patient requiring diuretics unless patient is taking potassium sparring diuretics
• Patient has acute renal failure, history of transplant, ESRD (however acceptable severe renal impaired group)
• 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 — Utrecht, Netherlands
• Novartis Investigative Site — Sankt Gallen, Switzerland
• Novartis Investigative Site — Merseyside, United Kingdom

Full record on ClinicalTrials.gov

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