Prostate Cancer Clinical Trial
Efficacy and Safety Study of Panobinostat in Participants With Metastatic Hormone Refractory Prostate Cancer
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.
Eligibility 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:
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
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.
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There are 5 Locations for this study
Baltimore Maryland, 21201, United States
Baltimore Maryland, 21287, United States
Saint Louis Missouri, 63130, United States
New York New York, 10065, United States
Madison Wisconsin, 53706, United States
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