Perifosine (P) as an active agent in the treatment of patients with advanced sarcoma

10059 Background: Clinical benefit rate (CBR), defined as complete or partial responses (RECIST) or stable disease > 4 months, has been taken as evidence for the activity of mTOR inhibitors in sarcomas, (Chawla ASCO 2006). P is a novel oral alkylphosphocholine that targets the PI3K pathway upstream from mTOR by inhibiting the phosphorylation of Akt. (Kondapaka, Mol Cancer Ther 2003). P's activity against sarcomas has now been evaluated in 121 patients enrolled in one of 3 phase (ph) I trials or 4 ph II studies. Five of these studies have been published. All of the data are in the Keryx database from which this analysis was performed. Methods: Dose-schedules in the ph I trials were weekly (wkly) 100–800 mg; loading dose (LD) 300 - 1,800 following by daily (d) 50 - 21 every 21 days; LD 400 - 900 & d 50 - 100 continuously. In the ph II trials doses were LD 900 & d 150 every 21 days, LD 900 and d 100 continuously, d 50 mg continuously; wkly 900, wkly1200 & wkly 1,500. Regimens that included a wkly or LD of 1,...