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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00997399
First received: October 15, 2009
Last updated: October 18, 2013
Last verified: October 2013
  Purpose

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: 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:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the effect of varying degrees of renal function on the safety of panobinostat [ Time Frame: Entire duration of study ] [ Designated as safety issue: Yes ]
  • To evaluate whether there is a relationship between PK and safety parameters in patients with varying degrees of renal function. [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • To explore anti-tumor activity associated with panobinostat. [ Time Frame: 6 months (6 cycles) ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: March 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LBH589 Drug: panobinostat (LBH589)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00997399

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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00997399     History of Changes
Other Study ID Numbers: CLBH589X2105, 2009-012263-34
Study First Received: October 15, 2009
Last Updated: October 18, 2013
Health Authority: United States: Food and Drug Administration
Switzerland: Swissmedic
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on July 23, 2014