A phase 2 trial of XXXX ( @entity19878 ), an epothilone B analog, given daily x 5 in @entity0 .

@entity1 @entity137 @entity0 @entity21597 @entity882 @entity16 @entity19878 @entity1295 @entity294 @entity3907 @entity1398 @entity925 @entity158 @entity4841 @entity1142 @entity2359 @entity1209
UNASSIGNED: 545 Background: The @entity21597 are nontaxane microtubule stabilizers which have shown promising activity in 1- and 3-hour infusions every 3 weeks. Grade 3 @entity16 was reported in 12-37% of @entity0 @entity1 . METHODS: @entity1 with metastatic or locally advanced @entity0 and measurable disease were stratified by prior @entity3907 therapy. @entity1 were treated with @entity19878 at 6 mg/m(2)/d IV d1-5, every 3 weeks. A novel battery of tests to assess @entity2359 included subjective questionnaires, balance testing, Semmes-Weinstein monofilaments, the Jebsen Test of Hand Function, the Grooved Peg Board Test, and nerve conduction studies. RESULTS: Forty-two @entity1 received 174 cycles. Prior @entity3907 -treated @entity1 received 0-10 (median 2) prior chemo regimens; @entity3907 na  ve @entity1 received 0-1 (median 0) prior chemo regimens. Grade 3 and 4 @entity137 per @entity1 : @entity1398 (32%, grade 4: 20%), @entity1398 (10%, all grade 3), @entity882 (5%), @entity1295 (15%), @entity294 (12%), @entity1209 (5%), @entity1142 (2%), @entity925 / @entity4841 (2%), @entity16 (grade 3: 2%, all grades: 40%). Of the 33 prior @entity3907 -treated @entity1 , there are 6 (18%) PR, 12 (40%) SD, 12 (40%) PD, 3 (9%) too early to evaluate (TE). Of the 9 @entity3907 -naive @entity1 , 4 (44%) PR, 4 (44%) SD, and 1 (11%) TE. One @entity1 was removed from study due to grade 3 @entity2359 , and 2 pts for other grade 3/4 @entity137 . Eleven of 30 (37%) @entity1 with no baseline @entity16 developed grade 1; 3 (10%) of 30 developed grade 2; 1 (3%) developed grade 3. Only 1 of 12 (8%) @entity1 with baseline grade 1 developed grade 2 @entity16 . @entity16 was associated with self-reported worsening of @entity158 intensity (p<0.01), but not with the other @entity2359 tests evaluated, and further analyses are ongoing. Eight @entity1 have had pre- and post-treatment biopsies. Tubulin stabilization will be assessed by examining post-translational modifications of tubulin on pre- and post-therapy biopsies by Western blot. CONCLUSIONS: Responses are seen in both prior @entity3907 -treated and @entity3907 na  ve @entity1 . @entity16 was mild with grade 3 @entity2359 rarely seen. [Table: see text].
