Summary of DLTs and moderate toxicities during dose escalation
| Cohort . | Phase . | Bortezomib, mg/m2 . | Romidepsin, mg/m2 . | n . | Toxicity . |
|---|---|---|---|---|---|
| 1 | Accelerated | 1.3 | 8 | 1 | None in cycle 1 |
| 2 | Accelerated | 1.3 | 10 | 1 | None in cycle 1 |
| 3 | Accelerated | 1.3 | 12 | 1 | DLTs at cycle 1: platelet count < 25 × 109/L; febrile neutropenia |
| 4 | Standard escalation | 1.3 | 12 | 4 | 2 patients with DLTs at cycle 1: (1) Intracerebral hemorrhage grade 5 in the setting of PD and grade 4 thrombocytopenia (2) Bowel obstruction |
| 5 | Standard escalation | 1.3 | 10 | 3* | No DLTs |
| Cohort . | Phase . | Bortezomib, mg/m2 . | Romidepsin, mg/m2 . | n . | Toxicity . |
|---|---|---|---|---|---|
| 1 | Accelerated | 1.3 | 8 | 1 | None in cycle 1 |
| 2 | Accelerated | 1.3 | 10 | 1 | None in cycle 1 |
| 3 | Accelerated | 1.3 | 12 | 1 | DLTs at cycle 1: platelet count < 25 × 109/L; febrile neutropenia |
| 4 | Standard escalation | 1.3 | 12 | 4 | 2 patients with DLTs at cycle 1: (1) Intracerebral hemorrhage grade 5 in the setting of PD and grade 4 thrombocytopenia (2) Bowel obstruction |
| 5 | Standard escalation | 1.3 | 10 | 3* | No DLTs |
PD indicates progressive disease.
The next cohort was in the expansion phase (n = 15) at this dose level.