Table 2. Dose-escalation and assessment of DLTs in pediatric patients treated with oral ridaforolimus (N = 20).
| Dose level | Dose, mg/m2 | Patients treated, n | Patients evaluable for DLT, n | Patients with DLT, n | Time to DLT onset, days | Median (range) time on therapy, cycles |
|---|---|---|---|---|---|---|
| 1 | 22 | 4 | 3 | 0 | — | 2 (2–12) |
| 2 | 28 | 3 | 3 | 0 | — | 2 (2–4) |
| 3 | 33 | 7 | 6 | 1 (grade 3 increased ALT) | 22 (cycle 1) | 2 (1–46)a |
| RP2D expansion | 33 | 6 | 6 | 0 | — | — |
a
Cycles on therapy for all patients treated with ridaforolimus 33 mg/m2 during dose escalation and RP2D expansion (n = 13).