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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
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

Drug Information available for: Romidepsin
U.S. FDA Resources

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]
  • To evaluate the time to objective disease progression. [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]

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)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00106301

Locations
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
Investigators
Study Director: William McCulloch, MB, FRCP Gloucester Pharmaceuticals Inc.
  More Information

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00106301     History of Changes
Other Study ID Numbers: FJ-228-0007
Study First Received: March 22, 2005
Last Updated: August 29, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
FK228
Hormone Refractory Prostate Cancer

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Carcinoma, Renal Cell
Prostatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
 Kidney Diseases
Urologic Diseases
Genital Neoplasms, Male
Genital Diseases, Male
Prostatic Diseases
Romidepsin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013