NCT00493766

Safety of LBH589 Alone and in Combination With IV 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)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a parallel, two-arm, open-label, multicenter phase IA/IB study of LBH589 (oral formulation) alone and in combination with docetaxel in patients with progressing hormone refractory prostate cancer. This study is designed to determine the maximum tolerated dose of LBH589 as a single agent and in combination with docetaxel and prednisone 5 mg two times a day , and to characterize the safety, tolerability, biologic activity and pharmacokinetic profile

Conditions

• Hormone Refractory Prostate Cancer

Interventions

Type	Name	Description
DRUG	LBH589

Timeline

• Start date: 2006-05-01
• Primary completion: 2008-07-01
• First posted: 2007-06-28
• Last updated: 2020-12-19

Locations

5 sites across 1 country: United States