Phase I study of oral @entity1945 in XXXX .

@entity1 @entity137 @entity6961 @entity294 @entity33 @entity2590 @entity1295 @entity3052 @entity1503 @entity1583 @entity1945 @entity1209
PURPOSE: In this Phase I, dose-seeking study, we investigated the dose-limiting @entity137 (DLTs) and maximal tolerated dose (MTD) of oral @entity1945 in @entity1 with @entity1583 . EXPERIMENTAL DESIGN: @entity1 with @entity2590 , @entity6961 , or relapsed @entity3052 were treated with 0.6-1.9 mg/m(2)/day oral @entity1945 for 5 consecutive days on and 2 days off, for 3 weeks (15 doses/course) followed by 2-4 weeks of rest. The DLTs occurring during the first course of treatment were considered for defining the MTD. Preliminary results of antitumor activity were assessed by examining bone marrow status and peripheral blood cell counts. RESULTS: All 26 @entity1 enrolled in the study were evaluable for @entity137 , and 24 @entity1 were evaluable for response. A total of 54 courses were administered. The most frequently reported nonhematological @entity137 (percentage of courses) were @entity294 (57%), @entity1209 (50%), @entity1295 (24%), and @entity33 (9%). DLTs included grade 3 or 4 @entity1209 and @entity294 at 1.9 mg/m(2)/day. The MTD for oral @entity1945 in @entity1 with @entity1583 was defined at 1.4 mg/m(2)/day. @entity1503 was noted in all 26 @entity1 and with all courses but was not considered dose-limiting. Four (17%) @entity1 achieved a complete response, and six (25%) @entity1 experienced hematological improvement. CONCLUSIONS: Protracted administration of oral @entity1945 is safe and well tolerated in @entity1 with @entity1583 . At the dose-schedule used, single-agent oral @entity1945 has a definite activity in @entity1 with @entity2590 and @entity3052 and warrants further investigation alone or in combination with other agents.
