Table 2 Treatment Exposure, Modifications, and Dose-limiting Toxicity – Safety Population (N = 23)
Parameter (unit) | Cohort 3 (Bel D1-3) n = 8a | Cohort 5 + Expansion (Bel D1-5) n = 15 |
|---|---|---|
Number of Bel-CHOP cycles administered, median (range) | 6.0 (1–6) | 6.0 (1–6) |
Cumulative dose received, median (range) | ||
Belinostat (mg/m2) | 17,622.0 (3036–18,000) | 29,120.0 (4815–30,510) |
Cyclophosphamide (mg/m2) | 4421.5 (761–4506) | 4460.0 (720–4578) |
Doxorubicin (mg/m2) | 295.0 (50–300) | 297.0 (49–306) |
Vincristine (mg) | 12.0 (2–12) | 12.0 (2–12) |
Prednisone (mg) | 3000.0 (300–3000) | 3000.0 (500–3000) |
RDI (%), median (range) | ||
Belinostat | 98.5 (94–101) | 98.0 (92–102) |
Cyclophosphamide | 99.5 (84–101) | 99.0 (92–102) |
Doxorubicin | 99.0 (85–100) | 100.0 (92–102) |
Vincristine | 100.0 (75–100) | 100.0 (75–00) |
Prednisone | 100.0 (60–100) | 100.0 (93–100) |
Patients with dose reduction due to AE, n (%) | ||
Belinostat | 1 (13) | 0 |
Cyclophosphamide | 2 (25) | 0 |
Doxorubicin | 2 (25) | 0 |
Vincristine | 1 (13) | 1 (7) |
Patients with dose interruption due to AE, n (%) | ||
Belinostat | 2 (25) | 2 (13) |
Doxorubicin | 0 | 1 (7) |
Vincristine | 1 (13) | 0 |
Patients with dose delay due to AE, n (%) | ||
Belinostat | 1 (13) | 0 |
Cyclophosphamide | 1 (13) | 0 |
Doxorubicin | 1 (13) | 0 |
Vincristine | 1 (13) | 0 |
Prednisone | 1 (13) | 0 |
Patients with DLT in Cycle 1, n (%) | 1 (13) | 0 |
Grade 3 nausea, vomiting, diarrhea, and dehydration | 1 (13) | 0 |