A phase 1/2 study of orally administered synthetic XXXX for treatment of recurrent @entity11 .

@entity1 @entity137 @entity1313 @entity5 @entity11 @entity463 @entity19486
BACKGROUND: @entity19486 is a potent inhibitor of @entity11 growth in vitro. To examine whether synthetic oral @entity19486 can be tolerated by @entity1 with recurrent @entity11 ( @entity463 ) and to investigate its efficacy against these @entity5 , the authors undertook an open-label, sequential dose escalation/de-escalation tolerance study. METHODS: @entity1 with documented recurrent or progressive @entity11 who had received standard radiation therapy with or without chemotherapy were included. @entity1 were excluded for previous treatment with agents known to contain @entity19486 or treatment within 30 days with medications known to cause photosensitivity. Enrolled @entity1 were given gradually increasing dosages of oral synthetic @entity19486 (0.05-0.50 mg/kg) for up to 3 months if no @entity137 was observed, and @entity1 response to treatment was noted. The @entity1 were examined each month and underwent magnetic resonance imaging to evaluate @entity5 status at 3 months. RESULTS: Synthetic @entity19486 administered orally appeared to provide stabilization or a slight (<50%) decrease in @entity5 volume (coded as stable disease) at 3 months for 7 of 42 @entity1 (17%) and produced a @entity5 reduction >50% (partial response) in 2 @entity1 (5%). Seventeen @entity1 (40%) survived for 3 months on daily synthetic @entity19486 at dose levels of 0.33    0.070 mg/kg daily. The mean maximum tolerated dose was 0.40    0.098 mg/kg daily. Twelve @entity1 continued on @entity19486 therapy beyond 3 months. The median survival was 26 weeks (Kaplan-Meier method). CONCLUSIONS: The results of this study indicated that synthetic, oral @entity19486 is well tolerated in this @entity1 group. The response results were comparable to those reported from other studies of salvage therapies for recurrent @entity1313 .
