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