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

Stopped early · Phase 1

Conditions studied: Hormone Refractory Prostate Cancer Disease

In brief

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.

Key facts

Study ID

NCT00419536

Run by

Novartis Pharmaceuticals

People needed

108

Starts

2006-05-01

Last updated by the study team

2010-04-08

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.