Safety of LBH589 Alone and in Combination With Intravenous Docetaxel and Prednisone

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)

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.

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