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A Research Study for Patients With Metastatic Renal Cell Carcinoma

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

Condition Intervention Phase
Carcinoma, Renal Cell
Neoplasm Metastasis
Drug: FK228 (romidepsin)
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Celgene:

Primary Outcome Measures:
  • To evaluate the rate of objective response (the best response of Complete Response (CR), Partial Response (PR)). [ Time Frame: Up to 6 months ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: May 2003
Study Completion Date: August 2004
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FK228 (romidepsin)
13 mg/m2 of romidepsin
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00106613

United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-1023
Sponsors and Collaborators
Celgene Corporation
Study Director: William McCulloch, MB, FRCP Gloucester Pharmaceuticals Inc.
  More Information

Responsible Party: Celgene Corporation Identifier: NCT00106613     History of Changes
Obsolete Identifiers: NCT00058630, NCT00060216
Other Study ID Numbers: FJ-228-0001
Study First Received: March 28, 2005
Last Updated: August 30, 2012

Keywords provided by Celgene:
Renal Cell Carcinoma
Metastatic Cancer
Metastatic Renal Cell Carcinoma

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Neoplasm Metastasis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplastic Processes
Pathologic Processes
Antibiotics, Antineoplastic
Antineoplastic Agents processed this record on April 21, 2017