Continuation Trial Evaluating the Tolerability and Activity of FK228 in Patients That Completed Prior Study With FK228
This study has been completed.
Sponsor:
Celgene Corporation
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00106301
First received: March 22, 2005
Last updated: August 29, 2012
Last verified: August 2012
Tracking Information | |||||
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First Received Date ICMJE | March 22, 2005 | ||||
Last Updated Date | August 29, 2012 | ||||
Start Date ICMJE | April 2004 | ||||
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 ] [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
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 | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
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. |
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Detailed Description | This is a Phase II, non-randomized, open-label, single arm, continuation trial. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 Arm (s) | Experimental: FK228 (romidepsin)
romidepsin
Intervention: Drug: FK228 (romidepsin) |
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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 | 2 | ||||
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 | Both | ||||
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 | United States, United Kingdom | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00106301 | ||||
Other Study ID Numbers ICMJE | FJ-228-0007 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Celgene Corporation | ||||
Study Sponsor ICMJE | Celgene Corporation | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Celgene Corporation | ||||
Verification Date | August 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |