Table 3.
Grade 3 and 4 treatment-related adverse events occurring in both the DE and MTD part of the study.
| Adverse event, N (%) | Cohort 1 (N: 3) Belinostat 600 (mg/m2) Doxorubicin 50 (mg/m2) |
Cohort 2 (N: 7) Belinostat 600 (mg/m2) Doxorubicin 75 (mg/m2) |
Cohort 3 (N: 9) Belinostat 800 (mg/m2) Doxorubicin 75 (mg/m2) |
Cohort 4 (N: 6) Belinostat 1000 (mg/m2) Doxorubicin 75 (mg/m2) |
MTD (N: 16) Belinostat 1000 (mg/m2) Doxorubicin 75 (mg/m2) |
|---|---|---|---|---|---|
| Fatigue | |||||
| Grade 3 | 0 (0%) | 0 (0%) | 2 (22%) | 0 (0%) | 3 (19%) |
| Grade 4 | 0 (0%) | 0 (0%) | 1 (11%) | 0 (0%) | 0 (0%) |
|
| |||||
| Neutropenia | |||||
| Grade 3 | 0 (0%) | 3 (43%) | 2 (22%) | 1 (17%) | 4 (25%) |
| Grade 4 | 0 (0%) | 3 (43%) | 0 (0%) | 1 (17%) | 5 (31%) |
|
| |||||
| Anaemia | |||||
| Grade 3 | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 2 (13%) |
| Grade 4 | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
|
| |||||
| Febrile neutropenia | |||||
| Grade 3 | 0 (0%) | 1 (14%) | 0 (0%) | 0 (0%) | 2 (13%) |
| Grade 4 | 0 (0%) | 1 (14%) | 1 (11%) | 0 (0%) | 1 (6%) |
|
| |||||
| Mucosal inflam | |||||
| Grade 3 | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 1 (6%) |
| Grade 4 | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
|
| |||||
| Abdominal abscess | |||||
| Grade 3 | 0 (0%) | 1 (14%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Grade 4 | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
|
| |||||
| Bacteraemia | |||||
| Grade 3 | 0 (0%) | 1 (14%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Grade 4 | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
|
| |||||
| Prolonged QT | |||||
| Grade 3 | 0 (0%) | 1 (14%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Grade 4 | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
|
| |||||
| Neutrophil count | |||||
| Grade 3 | 0 (0%) | 1 (14%) | 0 (0%) | 3 (50%) | 0 (0%) |
| Grade 4 | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
|
| |||||
| Decreased appetite | |||||
| Grade 3 | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 1 (6%) |
| Grade 4 | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
|
| |||||
| Rash | |||||
| Grade 3 | 0 (0%) | 0 (0%) | 1 (11%) | 0 (0%) | 0 (0%) |
| Grade 4 | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
|
| |||||
| Neutropenic sepsis | |||||
| Grade 3 | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Grade 4 | 0 (0%) | 0 (0%) | 1 (11%) | 0 (0%) | 0 (0%) |
|
| |||||
| Hypersensitivity | |||||
| Grade 3 | 0 (0%) | 0 (0%) | 1 (11%) | 0 (0%) | 0 (0%) |
| Grade 4 | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
|
| |||||
| Headache | |||||
| Grade 3 | 0 (0%) | 0 (0%) | 1 (11%) | 0 (0%) | 0 (0%) |
| Grade 4 | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
|
| |||||
| Leukopenia | |||||
| Grade 3 | 0 (0%) | 0 (0%) | 0 (0%) | 1 (17%) | 0 (0%) |
| Grade 4 | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
|
| |||||
| Pneumonia | |||||
| Grade 3 | 0 (0%) | 0 (0%) | 0 (0%) | 1 (17%) | 0 (0%) |
| Grade 4 | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
|
| |||||
| Wound infection | |||||
| Grade 3 | 0 (0%) | 0 (0%) | 0 (0%) | 1 (17%) | 0 (0%) |
| Grade 4 | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
|
| |||||
| Neutrophil count decreased | |||||
| Grade 3 | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Grade 4 | 0 (0%) | 0 (0%) | 0 (0%) | 1 (17%) | 3 (19%) |
|
| |||||
| Platelet count decreased | |||||
| Grade 3 | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Grade 4 | 0 (0%) | 0 (0%) | 0 (0%) | 1 (17%) | 0 (0%) |
|
| |||||
| Blood sodium decreased | |||||
| Grade 3 | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Grade 4 | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 1 (6%) |
|
| |||||
| Diarrhoea | |||||
| Grade 3 | 0 (0%) | 1 (14%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Grade 4 | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
DE: dose escalation phase I study.
MTD: maximum tolerated dose phase II study.