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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-003315-30 | EudraCT Number |
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This Phase Ib dose escalation study is designed to characterize the safety, tolerability and preliminary efficacy of i.v. panobinostat (LBH589) in combination with docetaxel and prednisone in the 1st line treatment of patients with hormone refractory prostate cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LBH589 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LBH589 (i.v. panobinostat) | Drug | i.v. LBH589 dose levels: 10, 15, or 20 mg/m2 i.v. docetaxel 75 or 60 mg/m2 oral prednisone 5mg bid. LBH589 i.v. administered on days 1 and 8 in combination with docetaxel i.v. on day 1 and prednisone p.o 5mg bid every day of a 21-day cycle |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the MTD of i.v. LBH589 in combination with docetaxel and prednisone in patients with HRPC | determine if MTD occurs after every 3 - 6 pts |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the PK profile of i.v. LBH589 with and without docetaxel | PK assessment will occur during the first 2 weeks of each pt treatment. Minor safety throughout the study treatment phase | |
| To determine safety and tolerability of i.v. LBH589 in combination with docetaxel and prednisone in patients with HRPC |
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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 |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Rockville | Maryland | 20850 | United States | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Results for CLBH589C2205 can be found on the Novartis Clinical Trial Results Website | View source |
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|
| PK assessment will occur during the first 2 weeks of each pt treatment |
| To determine preliminary activity of i.v. LBH589 in combination with docetaxel and prednisone | PK assessment will occur during the first 2 weeks of each pt treatment |
| Detroit |
| Michigan |
| 48201 |
| United States |
| Novartis Investigative Site | St Louis | Missouri | 63110 | United States |
| Novartis Investigative Site | Las Vegas | Nevada | 89135 | United States |
| Novartis Investigative Site | New York | New York | 10021 | United States |
| Novartis Investigative Site | Durham | North Carolina | 27710 | United States |
| Novartis Investigative Site | Portland | Oregon | 97239 | United States |
| Novartis Investigative Site | Vancouver | British Columbia | V5Z 1L8 | Canada |
| Novartis Investigative Site | Hamilton | Ontario | L8V 5C2 | Canada |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital 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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