Table 2.
Dose escalation scheme, treatment delivery and cycle-one dose-limiting toxicity (DLTs)
| Cohort Number | Dose level (mg/m2/wk) | Dose increment | Number of patients | Total number of cycles (median per patient) | Total number of infusions (median per patient) | Number of patients with cycle-one DLT |
|---|---|---|---|---|---|---|
| 1 | 135 | - | 3 | 9 (2) | 32 (6) | 0 |
| 2 | 270 | 100% | 6 | 17 (2) | 50 (6) | 0 |
| 3 | 540 | 100% | 6 | 11 (2) | 30 (5) | 1a |
| 4 | 675 | 25% | 7 | 12 (2) | 33 (5) | 0 |
| 5 | 900 | 33% | 4 | 6 (1.5) | 15 (4) | 2b |
agrade 4 thrombocytopenia; bgrade 4 thrombocytopenia and grade 4 neutropenia lasting > 5 day