Table 3.
Select non-hematologic adverse events of any causality by dose level: all grades.
| Dose (mg/m2) | 50 | 100 | 150 | 200 | 250 | 325 | 475 | 325 | 475* | 650 |
|---|---|---|---|---|---|---|---|---|---|---|
| Schedule | d1,8 | d1,8 | d1,8 | d1,8 | d1,8 | d1,8 | d1,8 | d1,8,15 | d1,8,15 | d1,8,15 |
| N patients | 4 | 4 | 4 | 4 | 3 | 3 | 3 | 4 | 6 | 5 |
| Dry eye | 1 | 1 | 2 | 1 | 1 | 1 | ||||
| Eye phototoxicity | 1 | 1 | 1 | 2 | 3 | |||||
| Diarrhea | 2 | 1 | 1 | 2 | 1 | 1 | 1 | |||
| Mucositis oral | 2 | 1 | 1 | 1 | 2 | |||||
| Nausea | 3 | 3 | 4 | 3 | 2 | 2 (1) | 1 | 1 | 6 | 3 |
| Fatigue | 4 | 3 | 3 | 2 | 2 | 3 (1) | 2 | 2 | 5 (2) | 3 (1) |
| Headache | 1 | 3 | 2 | 1 | 2 | 1 | ||||
| Palmar–plantar erythrodysesthesia syndrome | 1 | 1 | 1 | 2 | 1 | 1 | 1 | 1 | 1 (1) | |
| Phototoxicity | 2 (1) | 1 | 1 | 2 | 3 (1) | 1 | 3 | 4 (1) | 4 (2) | 3 (1) |
Forty patients were enrolled and treated with CX-5461.
*Includes one patient treated in the expansion phase.