Temsirolimus Versus Sorafenib As Second-Line Therapy In Patients With Advanced RCC Who Have Failed First-Line Sunitinib
Status:
Completed
Trial end date:
2013-01-01
Target enrollment:
Participant gender:
Summary
This is an international, randomized, open-label, outpatient, multicenter study. Subjects
will be assigned in a 1:1 ratio to 1 of 2 treatment arms: temsirolimus 25 mg once weekly by
intravenous (IV) infusion or sorafenib 400 mg by mouth (PO) twice daily (BID). These
investigational drugs will be administered in 6-week cycles for the duration of the study, up
to 24 months. Subjects will be stratified by nephrectomy status, duration of response to
sunitinib therapy, Memorial Sloan Kettering Cancer Center (MSKCC) prognostic group, and RCC
tumor histology.