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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-002986-30 | EudraCT Number |
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The study will determine the maximal tolerated dose (MTD) of panobinostat administered in combination with a fixed combination of cytarabine (ara-C) and mitoxantrone in adult patients with relapsed or refractory acute myeloid leukemia (AML).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LBH589 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| panobinostat/LBH589B | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose limiting toxicity (DLT) | 1 cycle (1 cycle = 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency, severity and duration of Adverse Events (AE) using CTCAE version 3.0 | During maximal three LBH589/chemotherapy cycles and subsequent optional single-agent LBH589 treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Paris | 75181 | France | |||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Results for LBH589B2116 can be found on the Novartis Clinical Trial Results Website | View source |
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| Paris |
| 75475 |
| France |
| Novartis Investigative Site | Dresden | 01307 | Germany |
| Novartis Investigative Site | Frankfurt | 60590 | Germany |
| Novartis Investigative Site | Hanover | 30625 | Germany |
| Novartis Investigative Site | Ulm | 89081 | Germany |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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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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