A Phase Ib Study of Rad001 and Sutent to Treat Renal Cell Carcinoma
Status:
Completed
Trial end date:
2012-12-01
Target enrollment:
Participant gender:
Summary
This is a single center, Phase Ib study of Sunitinib and RAD001 in patients with advanced
RCC. The study design is a phase I interpatient dose-escalation with a dose expansion at the
maximum tolerated dose (MTD) in patients with metastatic RCC . In the dose escalation
portion, patients will be treated with sunitinib, given in an intermittent schedule (2 weeks
of daily dosing followed by one week off drug. RAD001 will be given daily. Escalation of both
drugs will occur as tolerated. Treatment will be arbitrarily divided into 3-week cycles, with
dose limiting toxicity (DLT) determined by Cycle 2 Day 0.