A Research Study for Patients With Metastatic Renal Cell Carcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00106613
First received: March 28, 2005
Last updated: August 30, 2012
Last verified: August 2012

March 28, 2005
August 30, 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 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00106613 on ClinicalTrials.gov Archive Site
  • Rate of disease control, Complete Response, Partial Response, or Stable Disease [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • Time to objective disease progression. [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
  • Change from screening assessment to the final study visit in Karnofsky performance status. [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • Steady state plasma concentrations [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00106613
FJ-228-0001
No
Celgene Corporation
Celgene Corporation
Not Provided
Study Director: William McCulloch, MB, FRCP Gloucester Pharmaceuticals Inc.
Celgene Corporation
August 2012

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