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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-004788-23 | EudraCT Number |
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The primary purpose of this study is to identify the maximum tolerated dose (MTD) of both intravenous and oral panobinostat when given in combination with trastuzumab and paclitaxel. The study will evaluate safety and efficacy of the combination in adult female patients with HER2+ metastatic breast cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV LBH589 + trastuzumab + paclitaxel | Experimental | i.v. panobinostat |
|
| Oral LBH589 + trastuzumab + paclitaxel | Experimental | oral panobinostat |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV LBH589 | Drug |
| ||
| Oral LBH589 |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the maximum tolerated dose of oral panobinostat in combination with trastuzumab and paclitaxel. Determine the maximum tolerated dose of iv LBH in combination with trastuzumab and paclitaxel. | At least 21 day cycle for both arms |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability throughout the study for both IV and oral arms to determine the recommended dose for phase ll trials. | 4 weeks after end of treatment | |
| To evaluate the efficacy in the expansion phase of the trial when the MTD is defined. | throughout the study and 4 weeks after end of 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 | Mobile | Alabama | 36688 | United States | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Results for LBH589C2114 can be found on the Novartis Clinical Trial Results Website | View source |
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| Drug |
|
| trastuzumab | Drug |
|
| paclitaxel | Drug |
|
| Woodville |
| South Australia |
| 5011 |
| Australia |
| Novartis Investigative Site | Brussels | 1000 | Belgium |
| Novartis Investigative Site | Liège | 4000 | Belgium |
| Novartis Investigative Site | Province of Macerata | MC | 62100 | Italy |
| Novartis Investigative Site | Aviano | PN | 33081 | Italy |
| Novartis Investigative Site | Amsterdam | 1066 CX | Netherlands |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000077767 | Panobinostat |
| D000068878 | Trastuzumab |
| D017239 | Paclitaxel |
| 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 |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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