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

This study has been completed.
Sponsor:
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
History of Changes

March 22, 2005
August 29, 2012
April 2004
September 2006   (final data collection date for primary outcome measure)
Number of participants with adverse events [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00106301 on ClinicalTrials.gov Archive Site
  • To evaluate the effect of depsipeptide therapy on performance status as measured by the Karnofsky score assessment [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • To evaluate the time to objective disease progression. [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Continuation Trial Evaluating the Tolerability and Activity of FK228 in Patients That Completed Prior Study With FK228
A Multicenter, Open-Label Continuation Trial Evaluating the Tolerability and Activity of FK228 in Patients That Have Completed a Prior Clinical Study With FK228

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.

This is a Phase II, non-randomized, open-label, single arm, continuation trial.
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Carcinoma, Renal Cell
  • Prostatic Neoplasms
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
Experimental: FK228 (romidepsin)
romidepsin
Intervention: Drug: FK228 (romidepsin)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2
September 2006
September 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom
 
NCT00106301
FJ-228-0007
No
Celgene Corporation
Celgene Corporation
Not Provided
Study Director: William McCulloch, MB, FRCP Gloucester Pharmaceuticals Inc.
Celgene Corporation
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP