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

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00667862

Run by

Novartis Pharmaceuticals

People needed

35

Starts

2008-03-18

Expected to finish

2010-11-05

Last updated by the study team

2021-06-21

Who can join

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

You may qualify if…

• 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:
• two or more lesions on bone scan
• progressive measurable disease
• two documented increases in prostate-specific antigen (PSA)
• Willing to use contraception throughout the study and for 12 weeks after study completion

You may not qualify if…

• 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.

Where it is running

• University of Maryland — Baltimore, Maryland, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Washington University — St Louis, Missouri, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• University of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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