A Phase IA/IB, Two Arm, Multi-center, Open-label, Dose Escalation Study of Oral LBH589 Alone and in Combination With IV Docetaxel and Oral Prednisone in Hormone Refractory Prostate Cancer (HRPC)
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Hormone Refractory Prostate Cancer
Both
Hormone Refractory Prostate Cancer
Trial Information
A Phase IA/IB, Two Arm, Multi-center, Open-label, Dose Escalation Study of Oral LBH589 Alone and in Combination With IV Docetaxel and Oral Prednisone in Hormone Refractory Prostate Cancer (HRPC)
Inclusion Criteria
Inclusion criteria:
- Histologically documented adenocarcinoma of the prostate.
- Patients must have metastatic disease with at least one measurable soft tissue lesion
that can be assessed by computerized tomography (CT), or magnetic resonance imaging
(MRI) and/or detectable lesion(s) on bone scintigraphy scan. Patients with only
elevated prostate specific antegen (PSA) levels are not eligible for entry.
- Patients who have undergone medical castration must continue Luteinizing
hormone-releasing hormone (LHRH) agonist or antagonist therapy during study treatment
- Patients must be able to provide written informed consent
Exclusion criteria:
- Patients with prior or concurrent brain metastases
- Impaired cardiac, gastrointestinal, kidney, or liver function
- Use of therapeutic androgens
Other protocol-defined inclusion/exclusion criteria may apply
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
• To determine the maximum-tolerated dose (MTD) and dose-limiting toxicity (DLT) of esca-lating doses of LBH589 in adult men with HRPC.
Outcome Time Frame:
at study start and at study end
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CLBH589B2105
NCT ID:
NCT00493766
Start Date:
May 2006
Completion Date:
Related Keywords:
- Hormone Refractory Prostate Cancer
- LBH589
- Prostate Cancer
- HRPC
- Hormone Refractory Prostate Cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| Duke University Medical Center | Durham, North Carolina 27710 |
| Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
| Nevada Cancer Institute | Las Vegas, Nevada 89135 |
| Washing University School of Medicine | St. Louis, Missouri 63110 |
