Effect of gastrointestinal resection on sunitinib exposure in patients with GIST

BMC Cancer

Table 2 Summary of characteristics of studies used for analyses

Study number	Study design	Population (n)^a	Dosing schedule: dose	Day(s) of PK sampling	Time point(s) of sampling	Reference(s)
RTKC-0511-013	Phase II	74	2/1: 50 mg	Days 1, 14, 28 (only 4/2) of Cycles 1, 2, and 3 (optional)	Pre-dose	[19]
			2/2: 25, 50, 75 mg	Days 1, 14, 28 (only 4/2) of Cycles 1, 2, and 3 (optional)	On 1^st day of Cycle 1 and on last day of Cycles 1 and 2: 0, 1, 4, 6, 8, 10, 12, 24, and 48 hr post-dose (10 and 12 hr optional)
			4/2: 50 mg	Day 1 of Cycles 4, 5 (optional), and 6
A6181004	Phase III	179	4/2: 50 mg	Days 1, 14, and 28 of Cycle 1; Days 1 and 28 of Cycles 2 and beyond	Pre-dose	[20]
A6181045	Phase I/II	33	4/2: 25, 50, 75 mg	Phase I: Days 1, 2, 7, 14, 21, and 28 of Cycle 1	Pre-dose	[18]
				Phase I: Days 1, 2, 7, 14, 21, and 28 of Cycle 1	On Days 1 and 28 of Cycle 1 (Phase I Only): 0, 1, 2, 4, 6, 8, 10, 24 (Only Day 28) and 48 (Only Day 28) hr post-dose
				Phase II: Days 1, 14, and 28 of Cycles 1-4
A6181047	Phase II	19	CDD: 37.5 mg	Day 1 of each cycle	Pre-dose	[17]

Abbreviations: 2/1 2 weeks on treatment followed by 1 week off treatment, 2/2 2 weeks on treatment followed by 2 weeks off treatment, 4/2 4 weeks on treatment followed by 1 week off treatment, CDD continuous daily dosing, PK pharmacokinetics.
^aNumber of subjects from each study contributing to the ANCOVA.

ISSN: 1471-2407