Table 2 Dose levels, schedule, and dose-limiting toxicity.
Dose level | CX-5461 dose (mg/m2/dose) | Schedule (Q4 weeks) | Planned dose/week (mg/m2) | Number enrolled | Dose-limiting toxicities |
|---|---|---|---|---|---|
0 | 50 | Day 1 & 8 | 25 | 4 | |
1 | 100 | 50 | 4 | ||
2 | 150 | 75 | 4 | ||
3 | 200 | 100 | 4 | ||
4 | 250 | 125 | 3 | ||
5 | 325 | 163 | 3 | ||
6 | 475 | 238 | 3 | ||
7 | 325 | Day 1, 8 & 15 | 244 | 4 | |
8 | 475* | 356 | 6 | ||
9 | 650 | 488 | 5 | 2 ** |