Clinical Study
A Phase I/II Clinical Trial of Belinostat (PXD101) in Combination with Doxorubicin in Patients with Soft Tissue Sarcomas
Table 3
Grade 3 and 4 treatment-related adverse events occurring in both the DE and MTD part of the study.
| | Adverse event, (%) | Cohort 1 (: 3)
Belinostat 600 (mg/m2)
Doxorubicin 50 (mg/m2) | Cohort 2 (: 7)
Belinostat 600 (mg/m2)
Doxorubicin 75 (mg/m2) | Cohort 3 (: 9)
Belinostat 800 (mg/m2)
Doxorubicin
75 (mg/m2) | Cohort 4 (: 6)
Belinostat 1000 (mg/m2)
Doxorubicin 75 (mg/m2) | MTD (: 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%) |
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DE: dose escalation phase I study.
MTD: maximum tolerated dose phase II study.
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