Intercalated Dosing Schedule of @entity3866 and XXXX as a Therapeutic Strategy to Avoid Antagonism and Optimize Its Benefits in Advanced @entity1149 . A  Randomized Phase II Clinical Trial.

@entity1 @entity1149 @entity1349 @entity1205 @entity3866
INTRODUCTION: The purpose of this study was to assess whether an intercalated dosing schedule of @entity3866 and @entity1205 could avoid possible negative interactions and optimize the benefit obtained as second-line therapy in @entity1149 ( @entity1149 ) @entity1 . @entity1 AND METHODS: A phase II randomized clinical trial was designed for advanced @entity1149 @entity1 in whom previous chemotherapy treatment had failed. The experimental arm with 33 @entity1 consisted of @entity3866 150 mg/d orally, intermittent administration on days 2 to 16 every 21 days, combined with @entity1205 75 mg/m(2) every 21 days; the control arm with 35 @entity1 consisted of @entity3866 150 mg/d orally, administered continuously. The study's primary end point was the proportion of @entity1 who remained progression-free  at 6 months in the 2 arms. RESULTS: The proportion of @entity1 who remained progression-free at 6 months was of 5 @entity1 (15%) in the intercalated arm and 3 @entity1 (9%) in the @entity3866 monotherapy arm respectively. Median progression-free survival (PFS)  was 3.0 versus 2.1 months (hazard ratio [HR], 0.65; 95% confidence interval [CI], 0.39-1.06; P  = .086). Median @entity1349 ( @entity1349 ) was 7.5 and 5.2 months (HR, 0.70; 95% CI, 0.41-1.19; P  = .19). Disease control rates were 51.7% and 36.4%, respectively. No new safety signals were observed. CONCLUSION: @entity3866 and @entity1205 with intermittent administration of @entity3866 improved PFS, @entity1349 , and disease control rates compared with @entity3866 alone. All of our results indicated that an intercalated dosing schedule of @entity3866 and @entity1205 could be more efficient than @entity3866 treatment  alone. Therefore, further studies should be developed in a larger number of @entity1 . This study has shown the  absence of antagonism between @entity1205 and @entity3866 when given in an intercalated fashion.
