Table 2

Dose-escalation scheme

Squalamine dose (mg/m2/day)No. of patientsTotal no. of coursesNo. of patients with DLT
NewReduced to this doseTotalFirst courseAll courses
610120/10/1
1210120/10/1
243 a0360/30/3
3410120/10/1
47.610110/10/1
66.6410140/10/1
9310140/10/1
13010120/10/1
18210130/10/1
25561714 b1/63/7
35761714 c0/61/7
50071816 d1/73/8
70030332/32/3
Total333673
  • a Before amending the criteria for DLT, one patient had a grade 3 elevation in hepatic transaminases that was considered dose-limiting, thus this dose level was expanded to three patients.

  • b The dose of squalamine was reduced in one patient from 357 to 255 mg/m2/day.

  • c The dose of squalamine was reduced in one patient from 500 (1 course) to 357 mg/m2/day (4 courses).

  • d The dose of squalamine was reduced in one patient from 700 to 500 mg/m2/day.