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This study will investigate the effect of oral LBH589 on dextromethorphan, a CYP2D6 substrate, and to assess safety and efficacy of oral LBH589 when used with this co-medication in advanced stage NSCLC or malignant pleural mesothelioma patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LBH589 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LBH589 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) parameters | first 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate assessed by comparing tumor size via radiology scans (CTs or MRIs) | day 10 through end of treatment | |
| Safety (until disease progression, unacceptable toxicity or study completion) assessed by duration of patient participation | first 10 days, day 10 through end of treatment plus follow-up |
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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 |
|---|---|---|---|---|---|---|
| Highlands Oncology Group | Fayetteville | Arkansas | 72703 | United States | ||
| Medical College of Georgia |
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| Label | URL |
|---|---|
| Results for CLBH589B2109 can be found on the Novartis Clinical Trial Results Website | View source |
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| Tolerability (until disease progression, unacceptable toxicity or study completion) assessed by duration of patient participation | day 10 through end of treatment |
| Augusta |
| Georgia |
| 30912 |
| United States |
| RUSH Medical Center | Chicago | Illinois | 60612 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Novartis Investigative Site | Ontario | Canada |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008654 | Mesothelioma |
| D008175 | Lung Neoplasms |
| D000086002 | Mesothelioma, Malignant |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018301 | Neoplasms, Mesothelial |
| D010997 | Pleural Neoplasms |
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| ID | Term |
|---|---|
| D000077767 | Panobinostat |
| ID | Term |
|---|---|
| D006877 | Hydroxamic Acids |
| D006898 | Hydroxylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002264 | Carboxylic Acids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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