Phase II study of XXXX in malignant @entity2615 .

@entity1 @entity137 @entity390 @entity417 @entity24986 @entity5 @entity1295 @entity2615 @entity1398 @entity1142
PURPOSE: Malignant @entity2615 (MPM) is a disease of increasing incidence for which treatment options are limited. This study reports the clinical efficacy data for @entity24986 , a novel microtubule inhibitor, in MPM. @entity1 AND METHODS: @entity1 with a histologically confirmed diagnosis of MPM were eligible for enrollment onto this multicenter phase II trial if they had not received prior chemotherapy or radiotherapy and had measurable lesions by Response Evaluation Criteria in @entity5 (RECIST) criteria. @entity24986 320 mg/m2 by 10-minute intravenous infusion was administered on day 1 of 21-day cycles. Modifications of dose and schedule were made according to National @entity5 Institute Common @entity137 Criteria version 2.0. Efficacy was assessed by an external, independent radiologist. The one-sample multiple testing procedure of Fleming was applied at the predetermined recruitment stages of 20 and 40 assessable @entity1 . RESULTS: Sixty-seven @entity1 were enrolled. Five @entity1 were not assessable for @entity5 response. The response rate was 13.8% (95% CI, 6.5% to 24.7%). The median survival was 10.8 months (95% CI, 7.8 to 12.0 months). The most common adverse events were @entity417 , @entity1398 , @entity1295 , @entity1142 , and @entity390 . Of grade 3 and 4 @entity137 , @entity1398 and @entity1142 were the most common (45% and 9% of @entity1 , respectively). CONCLUSION: @entity24986 can be delivered with high-dose intensity in @entity1 with MPM. The response rate and median survival are encouraging for a single agent. These data suggest that @entity24986 should be further evaluated in the management of MPM.
