Table 2.

DLTs by dose level

Dose level (mg once daily)DLT- evaluable/treated patients (n)Patients with DLTs (n)DLTs
804/40None
1603/40None
3206/70None
6406/821 Patient unable to receive 80% of planned dose owing to grade 2 fatigue, dehydration, dizziness, and hypotension
1 Patient with grade 3 nausea, vomiting, and dehydration