Continuation Trial Evaluating the Tolerability and Activity of FK228 in Patients That Completed Prior Study With FK228
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ClinicalTrials.gov Identifier: NCT00106301 |
Recruitment Status
:
Completed
First Posted
: March 23, 2005
Last Update Posted
: March 31, 2016
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Sponsor:
Celgene Corporation
Information provided by (Responsible Party):
Celgene Corporation
Tracking Information | ||||
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First Submitted Date ICMJE | March 22, 2005 | |||
First Posted Date ICMJE | March 23, 2005 | |||
Last Update Posted Date | March 31, 2016 | |||
Study Start Date ICMJE | April 2004 | |||
Actual Primary Completion Date | September 2006 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Number of participants with adverse events [ Time Frame: Up to 6 months ] | |||
Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | Complete list of historical versions of study NCT00106301 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Continuation Trial Evaluating the Tolerability and Activity of FK228 in Patients That Completed Prior Study With FK228 | |||
Official Title ICMJE | A Multicenter, Open-Label Continuation Trial Evaluating the Tolerability and Activity of FK228 in Patients That Have Completed a Prior Clinical Study With FK228 | |||
Brief Summary | The purpose of this study is to evaluate the safety and tolerability of extended treatment with FK228 in patients with metastatic renal cell carcinoma or hormone refractory prostate cancer who have at least demonstrated stable disease on prior Fujisawa sponsored FK228 clinical trials. | |||
Detailed Description | This is a Phase II, non-randomized, open-label, single arm, continuation trial. | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: FK228 (romidepsin)
Patients were continued at the same dose of romidepsin as in the previous study, which could have been 13 mg/m2 or a reduced dose of 10 mg/m2, administered intravenously over 4 hours on Days 1, 8, and 15 of each 28-day cycle.
Other Name: romidepsin |
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Study Arms | Experimental: FK228 (romidepsin)
romidepsin
Intervention: Drug: FK228 (romidepsin) |
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Publications * | Not Provided | |||
* 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 | |||
Actual Enrollment ICMJE |
2 | |||
Original Enrollment ICMJE |
40 | |||
Actual Study Completion Date | September 2006 | |||
Actual Primary Completion Date | September 2006 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United Kingdom, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00106301 | |||
Other Study ID Numbers ICMJE | FJ-228-0007 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Celgene Corporation | |||
Study Sponsor ICMJE | Celgene Corporation | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Celgene Corporation | |||
Verification Date | March 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |