Table 3.
Treatment Response
| Response by Initial Dosing Cohort | Efficacy Evaluable Population | Intent-to-Treat Population | ||||
|---|---|---|---|---|---|---|
| 85 mg (n=23) n (%) |
110 mg (n=20) n (%) |
Total (N=43) n (%) |
85 mg (n=28) n (%) |
110 mg (n=23) n (%) |
Total (N=51) n (%) |
|
| CR | – | 2 (10.0) | 2 (4.7) | – | 2 (8.7) | 2 (3.9) |
| PR | 6 (26.1) | 6 (30.0) | 12 (27.9) | 6 (21.4) | 6 (26.1) | 12 (23.5) |
| Durable SD* | 1 (4.3) | – | 1 (2.3) | 1 (3.6) | – | 1 (2.0) |
| Disease control rate CR+PR+ SD* | 7 (30.4) | 8 (40.0) | 15 (34.9) | 7 (25) | 8 (34.8) | 15 (29.4) |
| SD | 9 (39.1) | 7 (35.0) | 16 (37.2) | 9 (32.1) | 7 (30.4) | 16 (31.4) |
| PD | 7 (30.4) | 5 (25.0) | 12 (27.9) | 7 (25.0) | 5 (21.7) | 12 (23.5) |
| Not evaluable | – | – | – | 5 (17.9) | 3 (13.0) | 8 (15.7) |
*
Stable disease for at least 6 cycles