A phase II study of @entity2213 and @entity416 in metastatic XXXX : Southwest Oncology Group Study 0338.

@entity1 @entity1861 @entity0 @entity416 @entity5 @entity3820 @entity3 @entity2467 @entity669 @entity2213 @entity1487
BACKGROUND: @entity2213 is a potent inhibitor of the @entity1861 , @entity2467 , and @entity3820 ( @entity3820 ) @entity669 kinases. On the basis of variable expression of @entity2467 and @entity3820 in @entity0 and of in vitro data supporting synergy between @entity2213 and @entity416 , the Southwest Oncology Group conducted a phase II trial of the combination in metastatic @entity0 . @entity1 AND METHODS: Eligible @entity1 had progressive, measurable metastatic @entity0 and received<or=2 previous chemotherapy regimens for @entity3 . Previous @entity1487 or @entity416 for @entity3 was not allowed. @entity1 were accrued on a 2-stage design and received @entity2213 400 mg by mouth daily and @entity416 at 1000 mg/m2 by mouth twice daily for 14 days of a 21-day cycle. The primary endpoint was the confirmed response rate (RR). @entity5 were evaluated for @entity2467 , @entity3820 , and hormone receptor expression. RESULTS: Nineteen fully evaluable @entity1 were enrolled, with a confirmed RR of 11% (95% CI, 1%-33%). Eleven percent had unconfirmed partial responses, and 42% had stable disease. The trial did not accrue to the second stage. The estimated 6-month progression-free survival was 16% (95% CI, 0%-32%), and the median overall survival was 14 months (95% CI, 7-15 months). The combination was well tolerated. Of 8 available @entity5 samples, 2 stained for @entity2467 , and all had stromal staining for @entity3820 . CONCLUSION: In unselected @entity1 , the combination of @entity2213 and @entity416 was well tolerated but did not result in improved RRs compared to those reported with @entity416 alone.
