Status:
COMPLETED
A Research Study for Patients With Metastatic Renal Cell Carcinoma
Lead Sponsor:
Celgene
Conditions:
Carcinoma, Renal Cell
Neoplasm Metastasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 immunoth...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2004
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00106613
Start Date
May 1 2003
End Date
August 1 2004
Last Update
October 18 2019
Active Locations (3)
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1
City of Hope National Medical Center
Duarte, California, United States, 91010
2
University of Chicago
Chicago, Illinois, United States, 60637
3
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-1023