TABLE 3.
Dose-limiting toxicity (DLT)
Dose level | Evaluable patients | Patients with DLT | DLT | Attribution to protocol therapy |
---|---|---|---|---|
1a | 12 | 2 | Grade 3 elevated lipaseGrade 4 thrombocytopenia | ProbablyPossibly |
2 | 3 | 2 | Grade 3 diarrheaGrade 3 hyponatremia | DefinitelyPossibly |
Dose level | Age, years | Evaluable patients | Patients with DLT | |
1 | < 12 | 6 | 0 | |
≥ 12 | 6 | 2 | ||
2 | < 12 | 0 | 0 | |
≥ 12 | 3 | 2 |
Abbreviation: MTD, maximum tolerated dose.
17% of patients experience a DLT at the MTD.