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Study to Evaluate Panobinostat (DACi) Pharmacokinetics and Safety in Solid Tumors and Varying Renal Function

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: October 15, 2009
Last updated: November 5, 2014
Last verified: November 2014

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.

Condition Intervention Phase
Advanced Solid Tumors Drug: panobinostat (LBH589) Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Phase I, Open-label, Multi-center Study to Evaluate the Pharmacokinetics and Safety of Oral Panobinostat in Patients With Advanced Solid Tumors and Varying Degrees of Renal Function

Resource links provided by NLM:

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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) ]

Enrollment: 37
Study Start Date: March 2010
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LBH589 Drug: panobinostat (LBH589)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patient needing valproic acid for any medical condition during the study or within 5 days prior to the first panobinostat dose
  2. Patient received prior treatment with DAC inhibitors including panobinostat
  3. Patient requiring dialysis
  4. Patient requiring diuretics unless patient is taking potassium sparring diuretics
  5. Patient has acute renal failure, history of transplant, ESRD (however acceptable severe renal impaired group)
  6. 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

  Contacts and Locations
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Please refer to this study by its identifier: NCT00997399

United States, Utah
University of Utah / Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84103
Novartis Investigative Site
Leiden, Netherlands, 2300 RC
Novartis Investigative Site
Utrecht, Netherlands, 3584CX
Novartis Investigative Site
St. Gallen, Switzerland, 9007
United Kingdom
Novartis Investigative Site
Merseyside, United Kingdom, L63 4JY
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals Identifier: NCT00997399     History of Changes
Other Study ID Numbers: CLBH589X2105
2009-012263-34 ( EudraCT Number )
Study First Received: October 15, 2009
Last Updated: November 5, 2014

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Ph I
panobinostat (DACi)
PK & safety
solid tumors
varying renal function

Additional relevant MeSH terms:
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017