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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.
Information provided by (Responsible Party):
Celgene Corporation Identifier:
First received: March 22, 2005
Last updated: March 30, 2016
Last verified: March 2016
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.

Condition Intervention Phase
Carcinoma, Renal Cell Prostatic Neoplasms Drug: FK228 (romidepsin) Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label Continuation Trial Evaluating the Tolerability and Activity of FK228 in Patients That Have Completed a Prior Clinical Study With FK228

Resource links provided by NLM:

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: Up to 6 months ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 2
Study Start Date: April 2004
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FK228 (romidepsin)
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

Detailed Description:
This is a Phase II, non-randomized, open-label, single arm, continuation trial.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00106301

United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010-3000
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637-1470
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
United Kingdom
Royal Marsden Hospital
Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
Celgene Corporation
Study Director: William McCulloch, MB, FRCP Gloucester Pharmaceuticals Inc.
  More Information

Responsible Party: Celgene Corporation Identifier: NCT00106301     History of Changes
Other Study ID Numbers: FJ-228-0007
Study First Received: March 22, 2005
Last Updated: March 30, 2016

Keywords provided by Celgene Corporation:
Hormone Refractory Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Carcinoma, Renal Cell
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Kidney Diseases
Urologic Diseases
Antibiotics, Antineoplastic
Antineoplastic Agents processed this record on September 21, 2017