Efficacy and Safety Study of Panobinostat in Participants With Metastatic Hormone Refractory Prostate Cancer

A Phase II, Open Label, Single Arm Study of i.v. Panobinostat (LBH589) in Patients With Metastatic Hormone Refractory Prostate Cancer

This Phase II single dose study was designed to characterize the safety, tolerability, and efficacy of intravenous (i.v.) panobinostat as a single-agent treatment in participants with hormone refractory prostate cancer.

Inclusion criteria:

• Confirmed diagnosis of adenocarcinoma of the prostate

• Participants with metastatic hormone refractory prostate cancer

• Participants that have had at least one, but not more than two prior cytotoxic treatments for prostate cancer

• Evidence of disease progression by at least one of the following:

  1. two or more lesions on bone scan
  2. progressive measurable disease
  3. two documented increases in prostate-specific antigen (PSA)

• Willing to use contraception throughout the study and for 12 weeks after study completion

Exclusion criteria:

• History or clinical signs of central nervous system (CNS) disease
• History of other cancers not curatively treated with no evidence of disease for more than 5 years
• Prior radiotherapy within 3 weeks of starting study treatment
• Prior radiopharmaceuticals (strontium, samarium)
• Impaired cardiac function
• Heart disease
• Liver or renal disease with impaired function

Other protocol-defined inclusion/exclusion criteria may apply.