Dose and schedule
| Cohort . | No. . | Dose (mg/kg) . | Schedule . |
|---|---|---|---|
| 1 | 1 | 0.03 | Weekly ×4 |
| 2 | 1 | 0.1 | Weekly ×4 |
| 3 | 1 | 0.3 | Weekly ×4 |
| 4 | 3 | 1.0 | Weekly ×4 |
| 5 | 4 | 3.0 | Weekly ×4 |
| 6 | 7 | 6.0 | Weekly ×4 |
| 7 | 8 | 3.0 | Days 1, 3, and 5, then weekly ×3 |
| 8 | 8 | 10 | Cycle 1: 3 mg/kg day 1, 7 mg/kg day 3, then weekly ×3 |
| 9 | 8 | 15 | Cycle 1: 3 mg/kg day 1, 12 mg/kg day 3, then weekly ×3 |
| 10 | 9 | 20 | Cycle 1: 3 mg/kg day 1, 17 mg/kg day 3, then weekly ×3 |
| 11 | 4 | 6.0 | Days 1, 3, and 5, then once per week ×3 |
| 12 | 3 | 10 | Days 1, 3, and 5, then once per week ×3 |
| Expansion | 26 | 10, 20, or 30 | Once per week ×8, then once per month ×4 |
| Cohort . | No. . | Dose (mg/kg) . | Schedule . |
|---|---|---|---|
| 1 | 1 | 0.03 | Weekly ×4 |
| 2 | 1 | 0.1 | Weekly ×4 |
| 3 | 1 | 0.3 | Weekly ×4 |
| 4 | 3 | 1.0 | Weekly ×4 |
| 5 | 4 | 3.0 | Weekly ×4 |
| 6 | 7 | 6.0 | Weekly ×4 |
| 7 | 8 | 3.0 | Days 1, 3, and 5, then weekly ×3 |
| 8 | 8 | 10 | Cycle 1: 3 mg/kg day 1, 7 mg/kg day 3, then weekly ×3 |
| 9 | 8 | 15 | Cycle 1: 3 mg/kg day 1, 12 mg/kg day 3, then weekly ×3 |
| 10 | 9 | 20 | Cycle 1: 3 mg/kg day 1, 17 mg/kg day 3, then weekly ×3 |
| 11 | 4 | 6.0 | Days 1, 3, and 5, then once per week ×3 |
| 12 | 3 | 10 | Days 1, 3, and 5, then once per week ×3 |
| Expansion | 26 | 10, 20, or 30 | Once per week ×8, then once per month ×4 |
Weekly means once per week. Patients in cohorts 5 through 12 could receive 2 additional 4-week cycles if there was evidence of clinical benefit.