Table 1.

Baseline demographics and disease characteristics

	Number of patients, n (%) (unless otherwise indicated)
	Cohort 1 (10 mg/kg) n = 3	Cohort 2 (20 mg/kg) n = 7	Cohort 3 (15 mg/kg) n = 6	All cohorts N = 16
Age, years
Median (range)	69.6 (59.6–71.4)	60.9 (35.6–70.3)	59.1 (50.5–69.7)	60.7 (35.6–71.4)
Sex
Male	3 (100.0)	5 (71.4)	2 (33.3)	10 (62.5)
Female	0	2 (28.6)	4 (66.7)	6 (37.5)
Race
Asian (Japanese)	3 (100.0)	7 (100.0)	6 (100.0)	16 (100.0)
Type of cancer†
Colorectal	1 (33.3)	5 (71.4)	1 (16.7)	7 (43.8)
Gastric	1 (33.3)	0	1 (16.7)	2 (12.6)
Gastrointestinal stroma	0	2 (28.6)	2 (33.3)	4 (25.0)
Head and neck	1 (33.3)	0	1 (16.7)	2 (12.5)
Sarcoma	0	0	1 (16.7)	1 (6.3)
Duration of disease, months‡
Median (range)	45.6 (2.4–61.4)	66.3 (32.5–90.4)	48.5 (25.5–102.5)	49.6 (2.4–102.5)
ECOG performance status
0	3 (100.0)	7 (100.0)	5 (83.3)	15 (93.8)
1	0	0	1 (16.7)	1 (6.3)
Metastatic site
Lung	2 (66.7)	2 (28.6)	3 (50.0)	7 (43.8)
Liver	1 (33.3)	6 (85.7)	3 (50.0)	10 (62.5)
Lymph nodes	1 (33.3)	2 (28.6)	3 (50.0)	6 (37.5)
Peritoneal	1 (33.3)	1 (14.3)	2 (33.3)	4 (25.0)
Pleural	1 (33.3)	0	0	1 (6.3)
Other	0	3 (42.9)	3 (50.0)	6 (37.5)
Prior disease-related therapy
Chemotherapy§	2 (66.7)	7 (100.0)	6 (100.0)	15 (93.8)
Other¶	0	2 (28.6)	1 (16.7)	3 (18.8)
Missing	1 (33.3)	0	0	1 (6.3)
Prior disease-related radiotherapy
Yes	0	0	1 (16.7)	1 (6.3)
No	3 (100.0)	7 (100.0)	4 (66.7)	14 (87.5)
Missing	0	0	1 (16.7)	1 (6.3)
Prior disease-related surgery
Yes	2 (66.7)	6 (85.7)	6 (100.0)	14 (87.5)
No	0	1 (14.3)	0	1 (6.3)
Missing	1 (33.3)	0	0	1 (6.3)

^†Not coded and was presented as reported.

^‡Duration of disease is time (in months) from date of histologic/cytologic confirmation of advanced solid tumor to date of first dose. If the day of first confirmation of cancer is unknown, it was replaced by 15MMMYYYY.

^§Includes agents such as cetuximab, sunitinib, imatinib, aflibercept, and bevacizumab.

^¶Other than chemotherapy, hormonal therapy, immunotherapy, and biologic therapy. ECOG, Eastern Cooperative Oncology Group.