Pharmacokinetics and Safety of Panobinostat in Patients With Advanced Solid Tumors and Various Degrees of Hepatic Function
| Status: | Completed |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 9/23/2012 |
| Start Date: | March 2010 |
| End Date: | November 2012 |
| Contact: | Novartis Pharmaceuticals |
| Phone: | +1 800 340 6843 |
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
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.
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.
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