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

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