A Research Study for Patients With Metastatic Renal Cell Carcinoma

Completed · Phase 2

Conditions studied: Carcinoma, Renal Cell, Neoplasm Metastasis

In brief

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.

Key facts

Study ID

NCT00106613

Run by

Celgene

People needed

30

Starts

2003-05-01

Expected to finish

2004-08-01

Last updated by the study team

2019-10-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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

Where it is running

• City of Hope National Medical Center — Duarte, California, United States
• University of Chicago — Chicago, Illinois, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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