Table 5.
Response to lestaurtinib (N = 46)
Best overall responses | |
PR | 2/46 |
Mixed | 3/46 |
Stable disease | 20/46 |
Progressive disease | 21/46 |
Number of treatment courses prior to PD | |
4–10 months | 11a/46 |
11–16 months | 3b/46 |
≥17 months | 3/46 |
Dose levels of response/SD > 5 months | |
Dose level 1–3 | 0/9 (total subjects at dose levels 1–3) |
Dose level 4–5c | 2/22 (2 SD) |
Dose level 5a–8d | 8/16 (2 PR, 2 Mixed, 4 SD) |
Complete response (CR), Partial response (PR), Stable disease (SD)
One of 11 patients stopped therapy after 5 cycles due to toxicity
One of 3 patients stopped therapy after 13 cycles due to toxicity
Cohorts expanded, dose de-escalated then re-escalated for toxicity monitoring
Modified dose escalation (level 5–5a increased by 15%)