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

• Status: Completed
• Trial end date: 2010-11-05
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Hormones; Panobinostat

Criteria

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.