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

Hormone Refractory Prostate Cancer Disease Clinical Trial

Official title: 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)

Status Terminated

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hormone Refractory Prostate Cancer Disease
• Prostatic Neoplasms

• NCT number: NCT00419536
• Study type: Interventional
• Source: Novartis
• Status: Terminated
• Phase: Phase 1
• Start date: May 2006