A Research Study for Patients With Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00106418|
Recruitment Status : Completed
First Posted : March 25, 2005
Last Update Posted : November 1, 2016
Information provided by (Responsible Party):
The purpose of this study is to evaluate the activity of romidepsin (depsipeptide,FK228) in patients with metastatic prostate cancer who have developed a rising prostate specific antigen (PSA) while undergoing hormonal therapy.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Metastases||Drug: Romidepsin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Exploratory Phase II, Multicenter, Open-label Trial Evaluating the Activity and Tolerability of FK228 in Androgen Independent Metastatic Prostate Cancer Patients With Rising PSA|
|Study Start Date :||May 2003|
|Actual Primary Completion Date :||September 2006|
|Actual Study Completion Date :||September 2006|
13 mg/m^2 of romidepsin intravenously over 4 hours on Days 1, 8, and 15 of each 28-day cycle.
13 mg/m2 of romidepsin intravenously over 4 hours on Days 1, 8, and 15 of each 28-day cycle.
Primary Outcome Measures :
- Rate of objective disease control [ Time Frame: Up to 6 months ]Rate of objective disease control was defined as the proportion of patients with confirmed CR, PR, or SD for at least 6 months, as determined by the Response Evaluation Criteria for Solid Tumors (RECIST).
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