Prostate Cancer Clinical Trial
Safety of LBH589 Alone and in Combination With Intravenous Docetaxel and Prednisone
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 safety, tolerability, biologic activity and pharmacokinetic profile.
Eligibility Criteria
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
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There are 3 Locations for this study
Boston Massachusetts, 02115, United States
St. Louis Missouri, 63119, United States
New York New York, 10021, United States
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