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.

View Eligibility Criteria

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.

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

35

Study ID:

NCT00667862

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There are 5 Locations for this study

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University of Maryland
Baltimore Maryland, 21201, United States
Johns Hopkins Hospital
Baltimore Maryland, 21287, United States
Washington University
Saint Louis Missouri, 63130, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
University of Wisconsin
Madison Wisconsin, 53706, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

35

Study ID:

NCT00667862

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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