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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00106301
Recruitment Status : Completed
First Posted : March 23, 2005
Last Update Posted : November 18, 2019
Information provided by (Responsible Party):

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.

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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
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
Actual Study Start Date : April 1, 2004
Actual Primary Completion Date : September 1, 2006
Actual Study Completion Date : September 1, 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Romidepsin

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. To evaluate the effect of depsipeptide therapy on performance status as measured by the Karnofsky score assessment [ Time Frame: Up to 6 months ]
  2. To evaluate the time to objective disease progression. [ Time Frame: Up to 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00106301

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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
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Study Director: William McCulloch, MB, FRCP Gloucester Pharmaceuticals Inc.

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Responsible Party: Celgene Identifier: NCT00106301     History of Changes
Other Study ID Numbers: FJ-228-0007
First Posted: March 23, 2005    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: November 2019
Keywords provided by Celgene:
Hormone Refractory Prostate Cancer
Additional relevant MeSH terms:
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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