MRI Study of BAY 43-9006 in Metastatic Renal Cell Carcinoma

Dynamic-Contrast Enhanced MRI Pharmacodynamic Study of BAY 43-9006 in Metastatic Renal Cell Carcinoma

The purpose of this study is to determine maximum tumor shrinkage, time to progression, survival, drug concentration, and degree of skin toxicity.

Inclusion Criteria:

• Histologically or cytologically confirmed metastatic clear cell renal cell cancer;
• At least one lesion that can be accurately measured in at least one dimension;
• Patients must not have been treated with prior anti-timor kinase inhibitors or VEGF pathway inhibitors;
• Age 18 and older;
• ECOG performance status 0-2;
• Blood pressure higher than 140/90 on 2 separate occasions not more than 6 weeks prior to enrollment and not less than 24 hours apart;
• Normal organ function: total bilirubin less than upper limit of normal, AST less than 2.5 X upper limit of normal, creatinine less than 2.8 mg/dl;
• Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation;
• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Chemotherapy or radiotherapy within 4 weeks prior to entering the study;
• Any other investigational agents;
• Known brain metastases;
• Uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements;
• Pregnancy.