Table 1.
Study design showing dose escalation and cohort identity.
| Cohort | Escalation step | Dose level (mg) | Number of patients |
|---|---|---|---|
| 1 | Starting dose | 10 | 1 |
| 2 | 2× starting dose | 20 | 1 |
| 3 | 4× starting dose | 40 | 1 |
| 4 | 8× starting dose | 80 | 3 |
| 5 | 16× starting dose | 160 | 3 |
| 6 | 20× starting dose | 200 | 4 |
| 7 (MFD) | 30× starting dose | 300 | 3 |
| 8 | CRC recommended dose | 100 | 4 |
MFD maximum feasible dose, CRC cohort review committee.
Dose levels (in milligrams) for each dose cohort, fold-escalation from starting dose, and the number of patients in each cohort are shown.