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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.
ClinicalTrials.gov Identifier: NCT00106301
Recruitment Status : Completed
First Posted : March 23, 2005
Last Update Posted : March 31, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Study Design

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
Study Start Date : April 2004
Primary Completion Date : September 2006
Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Romidepsin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00106301     History of Changes
Other Study ID Numbers: FJ-228-0007
First Posted: March 23, 2005    Key Record Dates
Last Update Posted: March 31, 2016
Last Verified: March 2016

Keywords provided by Celgene Corporation:
FK228
Hormone Refractory Prostate Cancer

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