Phase II study of XXXX for treatment of relapsed or refractory indolent non-Hodgkin's lymphoma and @entity1073 .

@entity1 @entity1210 @entity137 @entity417 @entity706 @entity882 @entity1074 @entity1295 @entity1073 @entity782
PURPOSE: We performed a phase II study of oral @entity782 , a histone and protein deacetylase inhibitor, to examine its efficacy and tolerability in @entity1 with relapsed/refractory @entity706 . @entity1 AND METHODS: In this open label phase II study (NCT00253630), @entity1 with relapsed/ @entity706 (FL), @entity1074 ( @entity1074 ), or @entity1073 ( @entity1073 ), with  <= 4 prior therapies were eligible. Oral @entity782 was administered at a dose of 200 mg twice daily on days 1 through 14 of a 21-day cycle until progression or unacceptable @entity137 . The primary end point was objective response rate (ORR), with secondary end points of progression-free survival (PFS), time to progression, duration of response, safety, and tolerability. RESULTS: All 35 eligible @entity1 were evaluable for response. The median number of @entity782 cycles received was nine. ORR was 29% (five complete responses [CR] and five partial responses [PR]). For 17 @entity1 with FL, ORR was 47% (four CR, four PR). There were two of nine responders with @entity1074 (one CR, one PR), and no formal responders among the nine @entity1 with @entity1073 , although one @entity1 maintained stable disease for 26 months. Median PFS was 15.6 months for @entity1 with FL, 5.9 months for @entity1073 , and 18.8 months for @entity1074 . The drug was well-tolerated over long periods of treatment, with the most common grade 3 adverse events being @entity882 , @entity417 , @entity1210 , and @entity1295 . CONCLUSION: Oral @entity782 is a promising agent in FL and @entity1074 , with an acceptable safety profile. Further studies in combination with other active agents in this setting are warranted.
