Study of rolapitant, a novel, long-acting, XXXX antagonist, for the prevention of chemotherapy-induced @entity1209 (CINV) due to highly emetogenic chemotherapy (HEC).

@entity1 @entity9766 @entity390 @entity900 @entity1295 @entity619 @entity10 @entity17939 @entity1296 @entity1142 @entity4757 @entity1209
PURPOSE: Rolapitant is a novel, long-acting @entity4757 ( @entity9766 antagonist. This study evaluated the safety and efficacy of four different doses of rolapitant for prevention of chemotherapy-induced @entity1209 (CINV) due to highly emetogenic chemotherapy (HEC). METHODS: This randomized, double-blind, active-controlled, global study was conducted in @entity1 receiving @entity900 -based chemotherapy >= 70  mg/m(2). @entity1 received a 9, 22.5, 90, or 180  mg oral dose of rolapitant or placebo with ondansetron and @entity619 on day 1 of chemotherapy. The primary end point was complete response (CR; no emesis and no use of rescue medication) in the overall (0 to 120  h) phase of cycle 1. Other assessments were CR in delayed (24-120  h) and acute (0-24  h) phases, no emesis, no significant @entity390 , and no @entity390 . RESULTS: Four hundred fifty-four @entity1 were randomized. All doses of rolapitant improved CR with the greatest benefit observed with rolapitant 180  mg vs. active control in the overall phase (62.5 and 46.7  %, p   =   0.032) and in the acute (87.6 vs. 66.7  %, p   =   0.001) and delayed (63.6 vs. 48.9  %, p   =   0.045) phases. Rates for no emesis and no significant @entity390 were significantly (p   <   0.05) higher with rolapitant 180  mg vs. active control in the overall, acute, and delayed phases. Treatment-related adverse events were largely considered related to the chemotherapy and included @entity1142 , @entity10 , @entity1295 , and @entity1296 which were mostly mild or moderate and were similar across treatment groups. CONCLUSION: All doses of rolapitant were well tolerated and showed greater CR rates than active control. @entity17939 180  mg demonstrated significant clinical efficacy for preventing CINV in the overall, delayed, and acute phases for @entity1 receiving HEC.
