Table 2 Summary of exposure and dose-limiting toxicities (safety analysis set).
E7449 dose cohort (n) | Median number of cycles received (range) | Evaluable patients, n | Patients with dose-limiting toxicity, n (%) | Dose-limiting-toxicity description |
|---|---|---|---|---|
50 mg (n = 3) | 6 (1, 8) | 3 | 0 | — |
100 mg (n = 3) | 2 (2, 14) | 3 | 0 | — |
200 mg (n = 4) | 3 (1, 4) | 4 | 0 | — |
400 mg (n = 4) | 5 (0, 10) | 3 | 0 | — |
600 mga (n = 8) | 2 (0, 13) | 6 | 1 (16.7) | Grade 3 anaphylactic reaction |
800 mg (n = 6) | 2 (0, 11) | 6 | 4 (66.7) | Grade 3 fatigue (n = 1) Grade 2 fatigue (n = 3) |
