Table 3 Escalation, de-escalation, elimination and stopping boundaries for each level depending on the number of patients with DLT
Action | The number of patients treated at each dose | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | |
Level 1: | ||||||||||||||||||
Stop the trial if # of DLT > = | NA | NA | 2 | 3 | 3 | 4 | 4 | 4 | 5 | 5 | 6 | 6 | 6 | 7 | 7 | 7 | 8 | 8 |
Level 2 and 3: | ||||||||||||||||||
Escalate if # of DLT < = | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 2 | 2 | 2 | 2 | 3 | 3 | 3 | 3 | 4 | 4 |
De-escalate if # of DLT > = | 1 | 1 | 2 | 2 | 2 | 3 | 3 | 3 | 4 | 4 | 4 | 5 | 5 | 6 | 6 | 6 | 7 | 7 |
Eliminate dose if # of DLT > = | NA | NA | 3 | 4 | 5 | 5 | 6 | 6 | 7 | 7 | 7 | 8 | 8 | 9 | 9 | 10 | 10 | 11 |