A phase II trial of perifosine in patients with advanced renal cell carcinoma (RCC) who have failed tyrosine kinase inhibitors (TKI)

5101 Background: The recently demonstrated activity of inhibitors of TORC1 in RCC has raised the possibility that even greater effects may be achieved by targeting upstream of this pathway. Perifosine is a synthetic alkylphospholipid which inhibits Akt activity and also has cell-dependent effects upon the MAP-kinase pathway. Prior single-agent trials showed disease stabilization/regression in patients (pts) with advanced RCC; however, few pts were previously treated with a TKI. Therefore, we conducted a multi-center phase II trial to determine the safety and efficacy of perifosine in pts with advanced RCC refractory to VEGFR TKI. Methods: Primary objectives were to measure the % of pts progression-free at 12 weeks (wks) and overall progression-free survival (PFS) of perifosine (100 mg qhs). Secondary objectives included overall response rate (> PR), and safety, Eligibility: ECOG PS 0–1, pts with metastatic RCC who have RECIST defined progression on either sunitinib or sorafenib. Prior Rx with immunotherap...