3. Best tumor response and PFS.
| Variables | n (%) | |||||||
| Escalation cohort (N=17) | Expansion cohort (N=24) | |||||||
| 50 mg/d
(N=3)* |
100 mg/d
(N=3) |
150 mg/d
(N=3) |
200 mg/d
(N=3) |
250 mg/d
(N=5) |
100 mg/d
(N=15) |
200 mg/d
(N=9) |
||
| *, Tumor response analysis was based on the full analysis set (FAS); PFS, progress-free survival; CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease; ORR, objective response rate; DCR, disease control rate; 95% CI, 95% confidence interval; NR, not reached. | ||||||||
| CR | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | |
| PR | 0 (0) | 0 (0) | 0 (0) | 1 (33.3) | 0 (0) | 1 (6.7) | 2 (22.2) | |
| SD | 3 (100) | 1 (33.3) | 2 (66.7) | 1 (33.3) | 3 (60.0) | 10 (66.7) | 6 (66.7) | |
| PD | 0 (0) | 2 (66.7) | 1 (33.3) | 1 (33.3) | 2 (40.0) | 4 (26.7) | 1 (11.1) | |
| ORR | 0 (0) | 0 (0) | 0 (0) | 1 (33.3) | 0 (0) | 1 (6.7) | 2 (22.2) | |
| DCR | 3 (100) | 1 (33.3) | 2 (66.7) | 2 (66.7) | 3 (60.0) | 11 (73.3) | 8 (88.9) | |
| PFS (month)
[mean (95% CI)] |
3.9 (2.1−9.7) | 3.8 (1.9−NR) | 9.9 (7.4−NR) | |||||