Safety and Pharmacokinetics of Motesanib in Combination with Panitumumab and Gemcitabine-Cisplatin in Patients with Advanced Cancer

Table 5

Best tumor response per modified RECIST as assessed by investigator.

		Motesanib dose cohort
	0 mg QD (𝑛=8)	50 mg QD (𝑛=8)	75 mg QD (𝑛=6)	100 mg QD (𝑛=6)	125 mg QD (𝑛=11)	75 mg BID (𝑛=2)
Patients with measurable disease at baseline, 𝑛 (%)	7 (88)	7 (88)	5 (83)	6 (100)	11 (100)	2 (100)
Response assessment, 𝑛 (%)
Confirmed complete responsea	0 (0)	0 (0)	0 (0)	1 (17)	0 (0)	0 (0)
Confirmed partial response	2 (25)	0 (0)	1 (17)	3 (50)	2 (18)	1 (50)
Stable disease	4 (50)	5 (63)	4 (67)	2 (33)	4 (36)	1 (50)
Durable stable diseaseb	1 (13)	0 (0)	3 (50)	1 (17)	1 (9)	0 (0)
Progressive disease	1 (13)	2 (25)	0 (0)	0 (0)	1 (9)	0 (0)
Unevaluablec	0 (0)	0 (0)	1 (17)	0 (0)	1 (9)	0 (0)
Not done	1 (13)	1 (13)	0 (0)	0 (0)	3 (27)	0 (0)
Clinical benefit rate (CR + PR + durable SD)	6 (75)	5 (83)	5 (83)	6 (100)	6 (55)	2 (100)
Confirmed objective response, % (95% CId)	25 (3.2–65.1)	0 (0–36.9)	17 (0.4–64.1)	4 (22.3–95.7)	18 (2.3–51.8)	50 (1.3–98.7)

BID: twice daily; QD: once daily; RECIST: Response Evaluation Criteria in Solid Tumors.
aPatients with a response assessment of complete response or partial response that was not confirmed within 4 weeks are reported as stable disease.
bDurable stable disease is defined as stable disease with a duration of ≥24 weeks.
cUnevaluable includes patients with a response assessment of complete response, partial response, or stable disease before the scheduled first assessment of response without an additional assessment of response.
dBinomial proportion with exact 95% confidence interval.