Table 1.
Objective response rate and disease control rate.
| Full Analysis Set (N = 23) | Per-Protocol Set (N = 8) | |
|---|---|---|
| Tumor response | ||
| CR | 0 (0.0) | 0 (0.0) |
| PR | 4 (17.4) | 4 (50.0) |
| SD | 3 (13.0) | 1 (12.5) |
| PD | 16 (69.6) | 3 (37.5) |
| Objective response rate a | 4 (17.4) | 4 (50.0) |
| (95% CI) | (5.0–38.8%) | (15.7–84.3%) |
| Disease control rate b | 7 (30.4) | 5 (62.5) |
| (95% CI) | (13.9–54.9%) | (24.5–91.5%) |
a CR + PR and b CR + PR + SD. CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease; CI, confidence interval. Data are presented as n (%) unless otherwise noted.