BACKGROUND/OBJECTIVE: @entity9433 is a potent @entity470 and @entity1722 inhibitor. @entity136 - @entity900 (GC) is a standard chemotherapy regimen for advanced/metastatic @entity150 . This phase I study examined the safety of @entity9433 in combination with GC in @entity1 with @entity150 . The primary aim was to determine the maximum tolerated dose (MTD) of @entity9433 in combination with GC. METHODS: A 3 + 3 dose escalation protocol was used with @entity9433 at 750, 1,000 and then 1,250 mg. It was dosed daily with @entity136 (1,000 mg/m2 on days 1, 8 and 15) and @entity900 (70 mg/m2 on day 2) every 28 days. In all, 18 @entity1 with a median age of 63 years (range 50-77) were included; 3/6, 3/5 and 6/7 @entity1 received @entity9433 at 750, 1,000 and 1,250 mg, combined with GC, in cohorts 1, 2 and 3, respectively. RESULTS: No dose-limiting @entity137 (DLTs) were observed in cohort 1 or 2 (3 @entity1 each); in cohort 3 (2 * 3 @entity1 ), 1 of the 6 @entity1 presented DLTs (grade 4, treatment-related @entity1398 and @entity177 ). Twelve @entity1 received 6 cycles. CONCLUSIONS: @entity9433 at 750-1,250 mg combined with GC appears safe and tolerable. The MTD of @entity9433 combined with GC in @entity150 was 1,250 mg.

Results from a Phase I Study of @entity9433 with XXXX and @entity900 in Advanced or Metastatic @entity150 : EORTC Trial 30061.

@entity1 :: ('9606', 'Species') :: ['patients'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicities'] @entity470 :: ('1956', 'Gene') :: ['HER1'] @entity9433 :: ('MESH:C490728', 'Chemical') :: ['lapatinib', 'Lapatinib'] @entity900 :: ('MESH:D002945', 'Chemical') :: ['cisplatin'] @entity177 :: ('MESH:D051437', 'Disease') :: ['renal failure'] @entity1398 :: ('MESH:D009503', 'Disease') :: ['febrile neutropenia'] @entity150 :: ('MESH:D001749', 'Disease') :: ['bladder cancer'] @entity136 :: ('MESH:C056507', 'Chemical') :: ['Gemcitabine', 'gemcitabine'] @entity1722 :: ('2064', 'Gene') :: ['HER2']
@entity136 :: (MESH:C056507,Chemical) :: ['Gemcitabine']
