Table 4.
Dose Level |
PPX mg/m2 |
Up to # of patients |
Next group of patients depend on # with DLT at current dose |
When 2 DLTs have occurred |
||
---|---|---|---|---|---|---|
If 0 DLT | If 1 DLT | If 2 DLTs | ||||
−1a | 135 | 3 | Stop, Go to expanded phase |
Go to −1b | Stop | Stop, no feasibility phase |
−1b | 135 | 3 | Stop, Go to expanded phase |
Stop | n/a | Stop, no feasibility phase |
1a | 175 | 3 | Go to 2a | Go to 1b | Stop | Go to −1 |
1b | 175 | 3 | Go to 2a | Stop | n/a | Go to −1 |
2a | 210 | 3 | Stop, Go to expanded phase |
Go to 2b | Stop | Stop, Go to 1,feasibility phase |
2b | 210 | 3 | Stop, Go to expanded phase |
Stop | n/a | Stop, Go to 1, feasibility phase |
n/a = not applicable