A Research Study for Patients With Metastatic Renal Cell Carcinoma

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: NCT00106613
Recruitment Status : Completed
First Posted : March 29, 2005
Last Update Posted : August 31, 2012
Information provided by (Responsible Party):
Celgene ( Celgene Corporation )

March 28, 2005
March 29, 2005
August 31, 2012
May 2003
August 2004   (Final data collection date for primary outcome measure)
To evaluate the rate of objective response (the best response of Complete Response (CR), Partial Response (PR)). [ Time Frame: Up to 6 months ]
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Complete list of historical versions of study NCT00106613 on Archive Site
  • Rate of disease control, Complete Response, Partial Response, or Stable Disease [ Time Frame: Up to 6 months ]
  • Time to objective disease progression. [ Time Frame: Up to 6 months ]
  • Number of Participants with Adverse Events [ Time Frame: Up to 6 months ]
  • Change from screening assessment to the final study visit in Karnofsky performance status. [ Time Frame: Up to 6 months ]
  • Steady state plasma concentrations [ Time Frame: Up to 6 months ]
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A Research Study for Patients With Metastatic Renal Cell Carcinoma
An Exploratory Phase II, Multicenter, Open-label Trial Evaluating the Activity and Tolerability of FK228 in Patients With Metastatic Renal Cell Carcinoma That is Progressive Following or During Immunotherapy
The purpose of this study is to evaluate the activity of FK228 in metastatic renal cell carcinoma (RCC) patients who have developed progressive disease (PD) following or during treatment with immunotherapy.
Not Provided
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Carcinoma, Renal Cell
  • Neoplasm Metastasis
Drug: FK228 (romidepsin)
Patients receive 13 mg/m2 of romidepsin (FK228) intravenously over 4 hours on Days 1, 8, and 15 of each 28-day cycle.
Other Name: romidepsin
Experimental: FK228 (romidepsin)
13 mg/m2 of romidepsin
Intervention: Drug: FK228 (romidepsin)
Stadler WM, Margolin K, Ferber S, McCulloch W, Thompson JA. A phase II study of depsipeptide in refractory metastatic renal cell cancer. Clin Genitourin Cancer. 2006 Jun;5(1):57-60.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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August 2004
August 2004   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Patients must fulfill all of the following criteria to be eligible for study participation:

  • Age ≥ 18 years;
  • Histologically confirmed Renal Cell Carcinoma (RCC);
  • Metastatic disease, with measurable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST);
  • Failure of prior cytokine therapy;
  • Documented progressive disease;

Exclusion Criteria:

Patients are ineligible for entry if any of the following criteria are met:

  • Significant cardiac disease including congestive heart failure, history of myocardial infarction within one year, uncontrolled dysrhythmias, or poorly controlled angina
  • History of serious ventricular arrhythmia
  • Corrected QT interval (QTc) ≥ 500 msec
  • Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C;
  • Previous extensive radiotherapy involving ≥ 30% of bone marrow
  • Coexistent second malignancy or history of prior malignancy within previous 5 years
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Celgene ( Celgene Corporation )
Celgene Corporation
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Study Director: William McCulloch, MB, FRCP Gloucester Pharmaceuticals Inc.
August 2012

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