Table 2.
Efficacy results
| Dose group | |||
|---|---|---|---|
| 40 mg (n = 33) | 80 mg (n = 32) | 120 mg (n = 32) | |
| Response | |||
| CBR, % | 30.3 | 25.0 | 25.0 |
| 98.3% CI | 13.3–52.4 | 9.5–47.2 | 9.5–47.2 |
| ORR, % | 9.1 | 9.4 | 6.3 |
| 98.3% CI | 1.3–27.9 | 1.3–28.6 | 0.4–24.3 |
| CR, n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| PR, n (%) | 3 (9.1) | 3 (9.4) | 2 (6.3) |
| SD ≥ 24 weeks, n (%) | 7 (21.2) | 5 (15.6) | 6 (18.8) |
| SD < 24 weeks, n (%) | 15 (45.5) | 14 (43.8) | 13 (40.6) |
| PD, n (%) | 8 (24.2) | 10 (31.3) | 11 (34.4) |
| Time to progression, months | |||
| Median | 4.6 | 3.7 | 3.6 |
| 95% CI | 3.6–5.4 | 2.1–5.7 | 1.9–5.6 |
CBR, clinical benefit rate; CI, confidence interval; CR, complete response; ORR, objective tumor response rate; PD, progressive disease; PR, partial response; SD, stable disease.