Table 3.
Dose levels evaluated and summary of severe clinical toxicities during all cycles of therapy
| COL-3 treatment group (daily dose, mg/m2) | ||||||||
|---|---|---|---|---|---|---|---|---|
| −EIAD | +EIAD | |||||||
| 25 | 50 | 75 | 100 | 25 | 50 | 75 | 100 | |
| No. of patients evaluateda | 3 | 3 | 3 | 8 | 3 | 6 | 4 | 4 |
| Hematologic toxicity (grade 4) | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Anemia | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Nonhematologic toxicity (grade 3/4) | 0 | 0 | 1 | 6 | 0 | 1 | 0 | 0 |
| Ataxia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| CNS hemorrhage | 0 | 0 | 0 | 0 | 0 | 1b | 0 | 0 |
| Diarrhea | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Fatigue | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Hypokalemia | 0 | 0 | 0 | 1 | 0 | 1b | 0 | 0 |
| Myalgia | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Photosensitivity | 0 | 0 | 1 | 2 | 0 | 0 | 0 | 0 |
−EIAD, patients not taking enzyme-inducing antiseizure drugs; +EIAD, patients taking enzyme-inducing antiseizure drugs
a
Total number of patients enrolled at each dose level
b
These two events occurred in the same patient, and were unlikely to be related to study drug but were considered dose-limiting and counted as one toxicity