Table 3. Summary of dose-limiting toxicities and serious adverse events.
Phase I | Phase II | |||
30 mg/d (n = 3) | 20 mg/d (n = 3) | 3-h infusion (20 mg/d) (n = 7) | 24-h infusion (60 mg/d) (n = 5) | |
Dose-limiting toxicity | Grade 3 somnolence/confusion (1); grade 3 ataxia (1) | 0 | 0 | 0 |
Serious TEAE, n (grade, attribution) | ||||
Febrile neutropenia | 1 (gr 3, NR) | 1 (gr 3, NR) | ||
Atrial fibrillation | 2 (gr 3, NR; gr 3, NR) | |||
Acute myocardial infarction | 1 (gr 3, NR) | 1 (gr 4, PS) | ||
Cough | 2 (gr 1, NR; gr 2, PS) | |||
Catheter site infection | 1 (gr 3, NR) | 1 (gr 3, NR) | ||
Cytokine release syndrome | 1 (gr 2, PR) | |||
Pneumonia | 1 (gr 3, NR) | 1 (gr 3, NR) | ||
Acute sinusitis | 1 (gr 1, NR) | |||
Dyspnea | 1 (gr 2, NR) | |||
Fatigue | 1 (gr 5, NR) | |||
Dizziness | 1 (gr 3, PR) |
AE, adverse event; DLT, dose-limiting toxicity (DLTs were defined as grade ≥3 infusion-related neurologic AEs and nonhematologic AEs not responsive to symptom-directed therapy); PR, probably related; PS, possibly related; NR, not related; TEAE, treatment-emergent adverse event.