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

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ClinicalTrials.gov Identifier: NCT00997399
Recruitment Status : Completed
First Posted : October 19, 2009
Last Update Posted : November 6, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: panobinostat (LBH589) Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
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
Study Start Date : March 2010
Primary Completion Date : June 2014
Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: LBH589 Drug: panobinostat (LBH589)

Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. To assess the effect of varying degrees of renal function on the safety of panobinostat [ Time Frame: Entire duration of study ]
  2. To evaluate whether there is a relationship between PK and safety parameters in patients with varying degrees of renal function. [ Time Frame: 7 days ]
  3. To explore anti-tumor activity associated with panobinostat. [ Time Frame: 6 months (6 cycles) ]

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00997399     History of Changes
Other Study ID Numbers: CLBH589X2105
2009-012263-34 ( EudraCT Number )
First Posted: October 19, 2009    Key Record Dates
Last Update Posted: November 6, 2014
Last Verified: November 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