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This study will characterize the safety, tolerability, biological activity, and pharmacokinetics of LBH589 in Japanese patients with advanced solid tumors whose disease has progressed despite standard therapies, or for whom no standard therapy exists.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LBH589 (Panobinostat) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LBH589 | Drug | 10, 15, 20 mg/m2, i.v. on day 1 and 8 of each 21 day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| To characterize the safety and tolerability of LBH589, including acute and chronic toxicities in Japanese patients with advanced solid tumors. | First cycle |
| Measure | Description | Time Frame |
|---|---|---|
| To characterize the pharmacokinetics (PK) of LBH589 | First cycle | |
| To evaluate any antitumor activity of LBH589 in patients with advanced solid tumors | Every 2 cycle |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmeceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigational Site | Aichi Prefecture | Japan | ||||
| Novartis Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21964801 | Derived | Morita S, Oizumi S, Minami H, Kitagawa K, Komatsu Y, Fujiwara Y, Inada M, Yuki S, Kiyota N, Mitsuma A, Sawaki M, Tanii H, Kimura J, Ando Y. Phase I dose-escalating study of panobinostat (LBH589) administered intravenously to Japanese patients with advanced solid tumors. Invest New Drugs. 2012 Oct;30(5):1950-7. doi: 10.1007/s10637-011-9751-0. Epub 2011 Oct 1. |
| Label | URL |
|---|---|
| Results for CLBH589A1101 can be found on the Novartis Clinical Trial Results Website | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077767 | Panobinostat |
| ID | Term |
|---|---|
| D006877 | Hydroxamic Acids |
| D006898 | Hydroxylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Hokkaido |
| Japan |
| Novartis Investigational Site | Hyogo Prefecture | Japan |
| D006880 |
| Hydroxy Acids |
| D002264 | Carboxylic Acids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |