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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00667862 |
This Phase II single dose study is designed to characterize the safety, tolerability and efficacy of i.v. panobinostat as a single-agent treatment in patients with hormone refractory prostate cancer.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: Panobinostat |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Open Label, Single Arm Study of i.v. Panobinostat (LBH589) in Patients With Metastatic Hormone Refractory Prostate Cancer |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion criteria
Evidence of disease progression by at least one of the following
Exclusion criteria
Other protocol-defined inclusion/exclusion criteria may apply
Contact: Novartis U.S. | 862-778-2705 | |
Contact: Novartis Basel | 41-61-324-1111 |
United States, Maryland | |
Johns Hopkins Hospital | Recruiting |
Baltimore, Maryland, United States | |
Contact: Regina huminski 410-955-4142 prietreg@jhmi.edu | |
Principal Investigator: Roberto Pili, M.D. | |
University of Maryland | Recruiting |
Baltimore, Maryland, United States | |
Contact: Michelle Besche 410-328-8610 mbesche@umm.edu | |
Principal Investigator: Arif Hussein, M.D. | |
United States, Missouri | |
Washington University | Recruiting |
St. Louis, Missouri, United States | |
Contact: Rebecca Patton rpatton@im.wustl.edu | |
Principal Investigator: Joel Picus, M.D. | |
United States, New York | |
Memorial Sloan Kettering Cancer Center | Recruiting |
New York, New York, United States | |
Contact: Erika Tanaka 212-557-0787 tanakae@mskcc.org | |
Principal Investigator: Dana Rathkopf, M.D. | |
United States, Wisconsin | |
University of Wisconsin | Recruiting |
Madison, Wisconsin, United States | |
Contact: Mary-Jane Staab 608-263-7107 mjs@medicine.wisc.edu | |
Principal Investigator: George Wilding, M.D. |
Study Chair: | Novartis | Novartis |
Study ID Numbers: | CLBH589C2208 |
Study First Received: | April 18, 2008 |
Last Updated: | September 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00667862 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Prostate Cancer Adenocarcinoma Prostate-Specific Antigen |
metastatic male HRPC DACi |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms |
Genital Diseases, Male Adenocarcinoma Prostatic Neoplasms |
Neoplasms Neoplasms by Site |