Status:
COMPLETED
Efficacy and Safety Study of Panobinostat in Participants With Metastatic Hormone Refractory Prostate Cancer
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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 refracto...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 18 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 5 2010
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00667862
Start Date
March 18 2008
End Date
November 5 2010
Last Update
June 21 2021
Active Locations (5)
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1
University of Maryland
Baltimore, Maryland, United States, 21201
2
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
3
Washington University
St Louis, Missouri, United States, 63130
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065