Table 1.
Phase I single agent studies of bortezomib
| Patient population | Prostate cancer | Advanced others solid tumors | Hepatocarcinoma |
|---|---|---|---|
| Number of patients | 53 | 46 | 14 |
| Schedule | Starting dose of 0.13 mg/m2 iv once weekly for 4 weeks q5 weeks | Arm 1: starting dose of 0.13 mg/m2 iv twice weekly for 4 weeks q6 weeks Arm 2: starting dose of 0.13 mg/m2 iv twice weekly for 2 weeks q3 weeks |
Starting dose of 1.0 mg/m2 iv on days 1, 4, 8, 11 q3 weeks |
| Best response obtained | 2 PR 2 SD | 1 PR | 7 SD |
| Toxicity observed | Diarrhea and hypotension | Neurotoxicity and fatigue | Thrombocytopenia, neurotoxicity and fatigue |
| MTD | 1.6 mg/m2 | Arm 1: 1.7 mg/m2 Arm 2: 1,6 mg/m2 | 1.3 mg/m2 |
Abbreviations: PR, partial response; SD, stable disease; MTD, maximum-tolerated dose.