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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-012263-34 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LBH589 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| panobinostat (LBH589) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the effect of varying degrees of renal function as defined by creatinine clearance), on the pharmacokinetics of panobinostat. | First 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the effect of varying degrees of renal function on the safety of panobinostat | Entire duration of study | |
| To evaluate whether there is a relationship between PK and safety parameters in patients with varying degrees of renal function. | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah / Huntsman Cancer Institute | Salt Lake City | Utah | 84103 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25377157 | Derived | Sharma S, Witteveen PO, Lolkema MP, Hess D, Gelderblom H, Hussain SA, Porro MG, Waldron E, Valera SZ, Mu S. A phase I, open-label, multicenter study to evaluate the pharmacokinetics and safety of oral panobinostat in patients with advanced solid tumors and varying degrees of renal function. Cancer Chemother Pharmacol. 2015 Jan;75(1):87-95. doi: 10.1007/s00280-014-2612-8. Epub 2014 Nov 7. |
| Label | URL |
|---|---|
| Results for CLBH589X2105 on the Novartis Clinical Trial Website | View source |
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| ID | Term |
|---|---|
| D000077767 | Panobinostat |
| ID | Term |
|---|---|
| D006877 | Hydroxamic Acids |
| D006898 | Hydroxylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| To explore anti-tumor activity associated with panobinostat. | 6 months (6 cycles) |
| Leiden |
| 2300 RC |
| Netherlands |
| Novartis Investigative Site | Utrecht | 3584CX | Netherlands |
| Novartis Investigative Site | Sankt Gallen | 9007 | Switzerland |
| Novartis Investigative Site | Merseyside | L63 4JY | United Kingdom |
| D006880 |
| Hydroxy Acids |
| D002264 | Carboxylic Acids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |