Study to Evaluate Panobinostat (DACi) Pharmacokinetics and Safety in Solid Tumors and Varying Renal Function
| Status: | Completed |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/19/2013 |
| Start Date: | February 2010 |
| End Date: | June 2014 |
| Contact: | Novartis Pharmaceuticals |
| Phone: | 1-888-669-6682 |
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
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.
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
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