The dose schedules in the Phase 1 trials were weekly 100-800 mg or loading dose (LD) 300-1800 mg on Day 1 followed by 50-150 mg daily for Days 2-21 every 28 days or LD 400-900 mg & daily 50-100 mg continuously.
In the Phase 2 trials, doses were LD 900 mg Day 1 & 150 mg daily for days 2-21 every 28 days; LD 900 mg and 100 mg daily continuously; 50 mg daily continuously without a LD; and 900-1500 mg weekly. LD was reduced for cycle 2+ of the 28 day regimens.
145 patients with sarcoma were entered on studies prior to December 31, 2006 and were assessed for CBR. Partial responses were seen, in one patient each, with chondrosarcoma, extra-skeletal myxoid chondrosarcoma, leiomyosarcoma and a desmoid tumor.
At lower doses with 52 patients fully evaluable for CBR, the CBR was 52% with 4 partial responses and 23 stable disease at >= 4 months.
At higher doses with 30 patients fully evaluable for CBR, the CBR was 53% with 16 stable disease at >= 4 months.
Toxicities were mainly gastrointestinal and/or fatigue. The percentage of patients with grade 0 nausea (N), vomiting (V), diarrhea (D) and fatigue (F) for lower dose perifosine (76 patients) was 46, 49, 38 and 55% respectively compared to 26, 32, 20 and 58 percent for higher dose perifosine (69 patients). The proportion of patients with grade 2+ N, V, D and F was 20, 13, 15 and 21% for lower dose perifosine and 49, 35, 42 and 25% for higher dose perifosine.
Conclusions - Perifosin
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