Quizartinib treatment exposure and dose modifications (safety population)
| . | Quizartinib 30-mg group* (n = 38) . | Quizartinib 60-mg group† (n = 36)‡ . | Total (N = 74) . |
|---|---|---|---|
| Median duration of treatment (range), wk | 9.4 (2.1-32.7) | 10.1 (1.7-109) | 10.0 (1.7-109) |
| Dose interrupted, n (%) | 8 (21) | 13 (36) | 21 (28) |
| Dose reduced, n (%) | 10 (26) | 10 (28) | 20 (27) |
| Dose escalated, n (%) | 23 (61) | 5 (14) | 28 (38) |
| . | Quizartinib 30-mg group* (n = 38) . | Quizartinib 60-mg group† (n = 36)‡ . | Total (N = 74) . |
|---|---|---|---|
| Median duration of treatment (range), wk | 9.4 (2.1-32.7) | 10.1 (1.7-109) | 10.0 (1.7-109) |
| Dose interrupted, n (%) | 8 (21) | 13 (36) | 21 (28) |
| Dose reduced, n (%) | 10 (26) | 10 (28) | 20 (27) |
| Dose escalated, n (%) | 23 (61) | 5 (14) | 28 (38) |
Quizartinib 30 mg and 60 mg are equivalent to 26.5 mg and 53 mg free base, respectively.
30-mg starting dose with permitted escalation to 60 mg for lack of or loss of initial response.
60-mg starting dose with permitted escalation to 90 mg for lack of or loss of initial response.
Two patients were randomized but did not receive drug because of ineligibility.