A Research Study for Patients With Prostate Cancer
This study has been completed.
Information provided by (Responsible Party):
First received: March 24, 2005
Last updated: September 12, 2014
Last verified: September 2014
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- Rate of objective disease control [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
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).
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2006 (Final data collection date for primary outcome measure)
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.
- FK 228
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Males ≥18 years;
- Written informed consent/authorization;
- Histological or cytological confirmation of metastatic prostate cancer with documented progression on hormonal therapy (objective progressive disease [PD], new bone lesions, or stable soft tissue or bone lesions with PSA increase);
- Patients must have either measurable disease or bone metastasis. Patients with measurable disease are preferred;
- Rising PSA, with a minimum study entry PSA of ≥5 ng/mL;
- Karnofsky performance status of ≥80%;
- Life expectancy of >12 weeks;
- For patients treated with anti-androgens, elevation of PSA must be demonstrated after cessation of anti-androgen treatment;
- Three lines of hormonal therapy are permitted prior to study entry (anti-androgen withdrawal is not considered as a second hormonal treatment);
- Serum testosterone level of <50 ng/mL in patients without surgical castration;
- Patients must have serum potassium levels >4.0 mEq/L and serum magnesium levels >2.0 mg/dL.
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History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 24, 2005
||September 12, 2014
||United States: Food and Drug Administration
Keywords provided by Celgene Corporation:
Androgen independent metastatic prostate cancer patients with rising PSA
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 28, 2015
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Site