@entity2239 and @entity22798 for advanced and metastatic XXXX .

@entity1 @entity137 @entity82 @entity5 @entity22798 @entity2239 @entity157 @entity1054 @entity4854
PURPOSE: Few treatment options are available for @entity1 with advanced or metastatic @entity157 ( @entity157 ). Based on preclinical and early clinical efficacy signals and lack of overlapping @entity137 , we undertook this multicenter phase II trial to estimate efficacy and safety of @entity2239 and @entity22798 in advanced @entity157 . METHODS: @entity1 with advanced @entity157 not amenable to locoregional therapy and @entity1 -Pugh A @entity82 received @entity2239 7.5 mg PO daily and @entity22798 LAR 60 mg IM every 28 days. The primary endpoint was @entity1054 ( @entity1054 ), with 26 events needed to evaluate if @entity2239 + @entity22798 improved @entity1054 from 2.8 to 4.4 months, with 80% power and an alpha of 0.05. Secondary endpoints included response as measured by RECIST modified for @entity157 , treatment-emergent adverse events, and overall survival. RESULTS: After 24 @entity1 were enrolled, results of a randomized trial showing no benefit of @entity2239 in @entity157 were released prompting an unplanned interim analysis that found the conditional probability of rejecting the null hypothesis based on events in those @entity1 was 0.08. Therefore accrual was halted. @entity1 had a median age of 59 years, 21 (88%) had BCLC stage C @entity5 , and 11 (46%) metastatic disease. Median @entity1054 was 3.5 months (95% CI 2-5.8) and median survival 6.7 months (95% CI 6-infinity). Best response was stable disease in ten @entity1 . Grade 3 @entity4854 occurred in 6 (25%). There were no grade 4 treatment-emergent events. CONCLUSION: Despite promising early efficacy signals, we found no benefit for the combination of @entity2239 and @entity22798 in @entity157 .
