Status:
TERMINATED
Safety of LBH589 Alone and in Combination With Intravenous Docetaxel and Prednisone
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Hormone Refractory Prostate Cancer Disease
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
This 2-arm study is designed to determine the maximum tolerated dose of LBH589 as a single agent and in combination with docetaxel and prednisone 5 mg twice daily (second arm) and to characterize the ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00419536
Start Date
May 1 2006
Last Update
April 8 2010
Active Locations (3)
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1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115-6084
2
Washington University School of Medicine
St Louis, Missouri, United States, 63119
3
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021