Pharmacokinetics and Safety of Panobinostat in Patients With Advanced Solid Tumors and Various Degrees of Hepatic Function

Advanced Solid Tumors Clinical Trial

Official title:

A Phase I, Open-label, Multicenter Study to Evaluate the Pharmacokinetics and Safety of Oral Panobinostat in Patients With Advanced Solid Tumors and Various Degrees of Hepatic Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01007968
• Other study ID #: CLBH589X2101
• Secondary ID: 2009-012262-31
• Status: Completed
• Phase: Phase 1
• Start date: March 2010
• Est. completion date: November 2012

Study information

• Verified date: August 2016
• 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 hepatic function status on panobinostat PK.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• 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 hepatic 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 requires treatment with warfarin that cannot be switched to another anticoagulant treatment prior to starting study drug

4. Patient has encephalopathy

5. Patient has ascites requiring intervention

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:
• LBH589

Locations

Country	Name	City	State
Netherlands	Novartis Investigative Site	Leiden
Sweden	Novartis Investigative Site	Lund
Sweden	Novartis Investigative Site	Stockholm
Switzerland	Novartis Investigative Site	St. Gallen
United Kingdom	Novartis Investigative Site	Edinburgh
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,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the effect of various degrees of impairment in hepatic function as measured by the National Cancer Institute-Cancer Therapy Evaluation Program (NCI-CTEP) criteria, on the pharmacokinetics of panobinostat.		first 7 days
Secondary	To assess the effect of various degrees of impairment in hepatic function on the safety of panobinostat		entire duration of study
Secondary	To evaluate whether there is a relationship between panobinostat PK and safety parameters in patients with various degrees of hepatic organ function		first 7 days
Secondary	To explore anti-tumor activity associated with panobinostat.		best overall response

External Links

•   Results for CLBH589X2101 on the Novartis clinical trial website