Table 1.
Patient demographics and baseline characteristics
|
Characteristics |
Arm A |
Arm B |
Arm C |
All patients |
|---|---|---|---|---|
| |
Motesanib |
Motesanib |
Motesanib |
|
| |
125 mg QD |
75 mg BID 2 wk on/1 wk off |
75 mg BID 5 d on/2 d off |
|
| n = 25 | n = 12 | n = 12 | N = 49 | |
| Sex, n (%) |
|
|
|
|
| Women |
10 (40) |
6 (50) |
5 (42) |
21 (43) |
| Men |
15 (60) |
6 (50) |
7 (58) |
28 (57) |
| Race, n (%) |
|
|
|
|
| White |
22 (88) |
11 (92) |
11 (92) |
44 (90) |
| Black |
2 (8) |
0 (0) |
0 (0) |
2 (4) |
| Hispanic |
1 (4) |
1 (8) |
0 (0) |
2 (4) |
| Native Hawaiian or other Pacific Islander |
0 (0) |
0 (0) |
1 (8) |
1 (2) |
| Median age (range), y |
59 (28–70) |
52 (30–70) |
59 (22–81) |
58 (22–81) |
| Age group, n (%) |
|
|
|
|
| <65 y |
18 (72) |
10 (83) |
9 (75) |
37 (76) |
| ≥65 y |
7 (28) |
2 (17) |
3 (25) |
12 (24) |
| ≥75 y |
0 (0) |
0 (0) |
1 (8) |
1 (2) |
| Tumor type, n (%) |
|
|
|
|
| Thyroid |
1 (4) |
7 (58) |
4 (33) |
12 (24) |
| Colon |
3 (12) |
0 (0) |
1 (8) |
4 (8) |
| Non–small-cell lung |
3 (12) |
0 (0) |
1 (8) |
4 (8) |
| Carcinoma of unknown origin |
1 (4) |
1 (8) |
0 (0) |
2 (4) |
| Cervix |
1 (4) |
0 (0) |
1 (8) |
2 (4) |
| Oral |
1 (4) |
0 (0) |
1 (8) |
2 (4) |
| Ovarian |
1 (4) |
0 (0) |
1 (8) |
2 (4) |
| Small-cell lung |
0 (0) |
2 (17) |
0 (0) |
2 (4) |
| Soft tissue sarcoma |
1 (4) |
0 (0) |
1 (8) |
2 (4) |
| Bile duct |
1 (4) |
0 (0) |
0 (0) |
1 (2) |
| Bone sarcoma |
1 (4) |
0 (0) |
0 (0) |
1 (2) |
| Esophageal |
1 (4) |
0 (0) |
0 (0) |
1 (2) |
| Kidney |
1 (4) |
0 (0) |
0 (0) |
1 (2) |
| Liver |
1 (4) |
0 (0) |
0 (0) |
1 (2) |
| Squamous cell carcinoma of head and neck |
1 (4) |
0 (0) |
0 (0) |
1 (2) |
| Other |
7 (28) |
2 (17) |
2 (17) |
11 (22) |
| ECOG performance status, n (%) |
|
|
|
|
| 0 |
14 (56) |
8 (67) |
9 (75) |
31 (63) |
| 1 |
10 (40) |
4 (33) |
3 (25) |
17 (35) |
| 2 |
1 (4) |
0 (0) |
0 (0) |
1 (2) |
| Disease stage, n (%) |
|
|
|
|
| Stage III |
1 (4) |
0 (0) |
0 (0) |
1 (2) |
| Stage IV |
22 (88) |
11 (92) |
11 (92) |
44 (90) |
| Unknown |
2 (8) |
1 (8) |
1 (8) |
4 (8) |
| Number of sites of disease,* n (%) |
|
|
|
|
| 0 |
1 (4) |
0 (0) |
1 (8) |
2 (4) |
| 1 |
13 (52) |
4 (33) |
3 (25) |
20 (41) |
| 2 |
10 (40) |
5 (42) |
6 (50) |
21 (43) |
| ≥3 |
1 (4) |
3 (25) |
2 (17) |
6 (50) |
| Number of prior therapies,† n (%) |
|
|
|
|
| 0 |
5 (20) |
1 (8) |
1 (8) |
7 (14) |
| 1 |
5 (20) |
1 (8) |
2 (17) |
8 (16) |
| 2 |
2 (8) |
1 (8) |
3 (25) |
6 (12) |
| ≥3 |
13 (52) |
9 (75) |
6 (50) |
28 (57) |
| Alcohol use, n (%) |
|
|
|
|
| Never |
1 (4) |
5 (42) |
4 (33) |
10 (20) |
| Former |
5 (20) |
1 (8) |
2 (17) |
8 (16) |
| Current |
18 (72) |
5 (42) |
5 (42) |
28 (57) |
| Missing | 1 (4) | 1 (8) | 1 (8) | 3 (6) |
BID = twice daily; ECOG = Eastern Cooperative Oncology Group; QD = once daily.
*Sites of disease as assessed by investigator.
†Prior therapies include all cancer therapies before study enrollment.