Table 3.
Best overall response and PFS
| 320 mg q.d. N = 20 | 480 mg q.d. N = 7 | 480 mg q.d., Fasted N = 17 | All N = 44 | |
|---|---|---|---|---|
| Overall response rate (CR + CRu + PR) | 12 | 7 | 9 | 28 |
| n % (95% CI) | 60.0 (36.1–80.9) | 100.0 (59.0–100.0) | 52.9 (27.8–77.0) | 63.6 (47.8–77.6) |
| Complete response rate (CR + CRu) | 5 | 4 | 6 | 15 |
| n % (95% CI) | 25.0 (8.7–49.1) | 57.1 (18.4–90.1) | 35.3 (14.2–61.7) | 34.1 (20.5–49.9) |
| Best overall response, n (%) | ||||
| CR | 2 (10.0) | 1 (14.3) | 1 (5.9) | 4 (9.1) |
| CRu | 3 (15.0) | 3 (42.9) | 5 (29.4) | 11 (25.0) |
| PR | 7 (35.0) | 3 (42.9) | 3 (17.6) | 13 (29.5) |
| SD | 4 (20.0) | 0 | 3 (17.6) | 7 (15.9) |
| PD | 4 (20.0) | 0 | 5 (29.4) | 9 (20.5) |
| NE | 0 | 0 | 0 | 0 |
| Median PFS, mo (95% CI) | 2.1 (1.8–NE) | 11.1 (1.4–NE) | 5.8 (1.0–5.8) | 2.9 (1.8–11.1) |
Abbreviations: SD, stable disease; PD, progressive disease; NE, not evaluable.