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

Advanced Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00997399
• Other study ID #: CLBH589X2105
• Secondary ID: 2009-012263-34
• Status: Completed
• Phase: Phase 1
• Start date: March 2010
• Est. completion date: June 2014

Study information

• Verified date: July 2019
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• panobinostat (LBH589)

Locations

Country	Name	City	State
Netherlands	Novartis Investigative Site	Leiden
Netherlands	Novartis Investigative Site	Utrecht
Switzerland	Novartis Investigative Site	St. Gallen
United Kingdom	Novartis Investigative Site	Merseyside
United States	University of Utah / Huntsman Cancer Institute	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Netherlands,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the effect of varying degrees of renal function as defined by creatinine clearance), on the pharmacokinetics of panobinostat.		First 7 days
Secondary	To assess the effect of varying degrees of renal function on the safety of panobinostat		Entire duration of study
Secondary	To evaluate whether there is a relationship between PK and safety parameters in patients with varying degrees of renal function.		7 days
Secondary	To explore anti-tumor activity associated with panobinostat.		6 months (6 cycles)

External Links

•   Results for CLBH589X2105 on the Novartis Clinical Trial Website