Continuation Trial Evaluating the Tolerability and Activity of FK228 in Patients That Completed Prior Study With FK228

Tracking Information
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; (submitted: August 29, 2012)	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; (submitted: August 29, 2012)	To evaluate the effect of depsipeptide therapy on performance status as measured by the Karnofsky score assessment [ Time Frame: Up to 6 months ]; To evaluate the time to objective disease progression. [ Time Frame: Up to 6 months ]
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
Condition ICMJE	Carcinoma, Renal Cell; Prostatic Neoplasms
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
Study Arms	Experimental: FK228 (romidepsin); romidepsin; Intervention: Drug: FK228 (romidepsin)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: August 29, 2012)	2
Original Enrollment ICMJE; (submitted: June 23, 2005)	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: Patient has completed 6 cycles of therapy in a prior Fujisawa-sponsored FK228 clinical trial;; Patient has immediate past participation (not to exceed 21 days from Day 15 of cycle 6 in the previous study) in a prior Fujisawa-sponsored FK228 clinical trial;; Patient has demonstrated stable disease, partial response or complete response as best overall response in their prior Fujisawa-sponsored FK228 clinical trial. Exclusion Criteria: Patient has been on a prior Fujisawa-sponsored FK228 clinical trial, left the trial and then received alternative anti-neoplastic therapy
Sex/Gender	Sexes Eligible for Study: All
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	Study Director: William McCulloch, MB, FRCP Gloucester Pharmaceuticals Inc.
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