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:
- Patients with hormone refractory prostate cancer
- Patients must have metastatic disease with at least 1 measurable soft tissue lesion
that can be assessed by CT or MRI and/or detectable lesion(s) on bone scintigraphy
scan. Patients with only elevated PSA levels are not eligible for entry.
- Patients must meet laboratory inclusion criteria defined in the protocol
- 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: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine the maximum tolerated dose
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CLBH589A2105
NCT ID:
NCT00419536
Start Date:
May 2006
Completion Date:
Related Keywords:
- Hormone Refractory Prostate Cancer Disease
- LBH
- LBH589
- Prostate Cancer
- HRPC
- Prostatic Neoplasms
Name | Location |
Memorial Sloan Kettering Cancer Center |
New York, New York 10021 |
Washington University School of Medicine |
Saint Louis, Missouri 63110 |
Dana Farber Cancer Institute |
Boston, Massachusetts 02115 |