Table 2.
Patient cohorts and DLTs
Dose level | Schedule | 17-AAG dose (mg/m2) | Cycle duration (d) | Patients | DLTs | Description of DLTs |
---|---|---|---|---|---|---|
1 | Daily × 5 | 5 | 21 | 1 | 0 | |
2 | Daily × 5 | 10 | 21 | 1 | 0 | |
3 | Daily × 5 | 20 | 21 | 2 | 0 | |
4 | Daily × 5 | 40 | 21 | 3 | 0 | |
5 | Daily × 5 | 80 | 21 | 7 | 2 | Thrombocytopenia (1 pt), diarrhea/hepatitis (1 pt) |
6 | Daily × 5 | 56 | 21 | 3 | 0 | |
7 | Daily × 3 | 80 | 14 | 3 | 0 | |
8 | Daily × 3 | 112 | 14 | 8 | 1 | Emesis (1 pt) |
9 | Daily × 3 | 157 | 14 | 4 | 2 | Nausea (1 pt), dyspnea (1 pt) |
10 | Days 1, 4, 8, and 11 | 112 | 21 | 3 | 0 | |
11 | Days 1, 4, 8, and 11 | 157 | 21 | 4 | 0 | |
12 | Days 1, 4, 8, and 11 | 220 | 21 | 6 | 1 | Hepatitis (1 pt) |
13 | Days 1, 4, 8, and 11 | 307 | 21 | 3 | 2 | Seizure (1 pt), abdominal pain/nausea/fever (1 pt) |
14 | Days 1 and 4 | 150 | 21 | 3 | 0 | |
15 | Days 1 and 4 | 210 | 21 | 3 | 0 |