Phase II study of @entity416 plus @entity900 as first-line chemotherapy in advanced XXXX .

@entity1 @entity3136 @entity416 @entity5 @entity294 @entity900 @entity391 @entity1398 @entity204 @entity420 @entity1487
BACKGROUND: A phase II study was conducted to assess the efficacy and tolerability of substituting @entity416 for @entity1487 in combination with @entity900 in @entity1 with advanced @entity5 . @entity1 AND METHODS: @entity1 with previously untreated metastatic or unresectable measurable biliary @entity420 received oral @entity416 1250 mg/m(2) twice daily on days 1-14, and intravenous @entity900 60 mg/m(2) on day 1. This cycle was repeated every 21 days. RESULTS: Forty-two @entity1 were enrolled in this study. Of these, 38 were assessable for efficacy and 41 were assessable for safety. A median of three cycles of treatment (range one to eight) were administered. One @entity1 achieved a complete response, and eight had partial responses, giving an overall response rate of 21.4% in the intention-to-treat population (95% confidence interval 9.1% to 33.9%). The median response duration was 5.1 months. The median time to progression and median overall survival were 3.7 and 9.1 months, respectively. The most common grade 3/4 adverse events were @entity1398 (20% of @entity1 ), @entity391 (12%), @entity294 (7%) and @entity3136 (5%). There were no treatment-related @entity204 . CONCLUSIONS: The combination of @entity416 and @entity900 has promising antitumor activity and is well tolerated in @entity1 with advanced @entity5 .
