2. Dose escalation schema, DLTs, dose reductions, and number of treatment days.
| Dose level | Patients (N=79) | DLTs in first cycle | Dose reduction (any cycle) (n) | No. of treatment days [median (range)] | |||
| Dose escalation (n=48) | Dose expansion (n=31) | Number | Description | ||||
| DLT, dose-limiting toxicity. | |||||||
| 10 mg qd | 6 | − | 0 | − | 0 | 46 (20−88) | |
| 10 mg bid | 4 | − | 0 | − | 0 | 88 (22−170) | |
| 20 mg bid | 3 | − | 0 | − | 0 | 106 (47−114) | |
| 40 mg bid | 3 | − | 0 | − | 0 | 57 (57−60) | |
| 120 mg qd | 8 | − | 0 | − | 0 | 112 (57−227) | |
| 60 mg bid | 8 | − | 0 | − | 1 | 86 (28−800+) | |
| 160 mg qd | 3 | − | 0 | − | 0 | 248 (44−393) | |
| 80 mg bid | 3 | 10 | 0 | − | 2 | 57 (28−632+) | |
| 100 mg bid | 3 | 10 | 0 | − | 0 | 257 (14−564) | |
| 150 mg bid | 3 | 11 | 0 | − | 3 | 56 (28−443+) | |
| 200 mg bid | 4 | − | 2 | 1 patient experienced grade 3 fatigue, nausea and vomiting and 1 patient experienced grade 3 abdominal pain | 3 | 66 (44−194) | |