A Research Study for Patients With Prostate Cancer
This study has been completed.
Sponsor:
Celgene Corporation
Information provided by:
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00106418
First received: March 24, 2005
Last updated: March 14, 2011
Last verified: March 2011
Tracking Information | |
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First Received Date ICMJE | March 24, 2005 |
Last Updated Date | March 14, 2011 |
Start Date ICMJE | |
Primary Completion Date | September 2006 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE | |
Original Primary Outcome Measures ICMJE | |
Change History | Complete list of historical versions of study NCT00106418 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE | |
Original Secondary Outcome Measures ICMJE | |
Current Other Outcome Measures ICMJE | |
Original Other Outcome Measures ICMJE | |
Descriptive Information | |
Brief Title ICMJE | A Research Study for Patients With Prostate Cancer |
Official Title ICMJE | 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 |
Brief Summary | 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. |
Detailed Description | |
Study Type ICMJE | Interventional |
Study Phase | Phase 2 |
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Condition ICMJE |
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Intervention ICMJE | Drug: romidepsin (depsipeptide, FK228) |
Study Arm (s) | |
Publications * | |
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |
Recruitment Status ICMJE | Completed |
Enrollment ICMJE | 25 |
Completion Date | September 2006 |
Primary Completion Date | September 2006 (final data collection date for primary outcome measure) |
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Male |
Ages | 18 Years and older |
Accepts Healthy Volunteers | No |
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
Location Countries ICMJE | |
Administrative Information | |
NCT Number ICMJE | NCT00106418 |
Other Study ID Numbers ICMJE | FJ-228-0002 |
Has Data Monitoring Committee | |
Responsible Party | |
Study Sponsor ICMJE | Celgene Corporation |
Collaborators ICMJE | |
Investigators ICMJE | |
Information Provided By | Celgene Corporation |
Verification Date | March 2011 |
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |