Table 6.
Dose level | Treatment | Toxicities | |||||
---|---|---|---|---|---|---|---|
| |||||||
Patient 1 | Patient 2 | Patient 3 | Patient 4 | Patient 5 | Patient 6 | ||
1 | 1.7 mg/kg/dose M–F*3w | 2G2 3G1 |
None | 1G2 2G1 |
1G2 4G1 |
||
2 | 1.7 mg/kg/dose MWF*6w | 1G1 | None | 2G1 | 2G1 | ||
3 | 1.7 mg/kg/dose M–F*6w | 3G2 5G1 |
1G2 1G1 |
1G1 | None | ||
4 | 1.9 mg/kg/dose M–F*6w | None | 1G1 | 1G3DLT 2G3 5G2 1G1 |
1G2 2G1 |
4G1 | 1G2 3G1 |
5 | 3.4 mg/kg/dose M–F*6w | 1G2 1G1 |
2G1 | 2G1 | None | ||
6* | 4.4 mg/kg/dose M–F*6w | 1G2 1G1 |
2G2 1G1 |
2G2 2G1 |
1G3DLT 2G3 2G2 2G1 |
2G2 2G1 |
1G3 3G2 6G1 |
7 | 5.5 mg/kg/dose M–F*6w | 1G2 | 1G2 1G1 |
2G2 2G1 |
1G3DLT 1G2 2G1 |
1G3DLT 1G3 2G2 1G1 |
2G2 6G1 |
8 | 7.1 mg/kg/dose M–F*6w | 2G2 1G1 |
2G2 1G1 |
2G2 2G1 |
1G3DLT 1G3 2G2 3G1 |
1G3DLT 1G3 4G2 5G1 |
|
9 | 9.2 mg/kg/dose M–F*6w | 1G3DLT 2G3 4G2 2G1 |
1G3DLT 1G2 1G1 |
nGm: n grade m non-DLT toxicities. nGmDLT: n grade m DLT toxicities.
Recommended maximum tolerated dose (MTD) by original Standard 3+3 design with dose de-escalation.
M: Monday. F: Friday. w: week. DLT: dose limiting toxicity.