Nonhematologic drug-related toxicities in patients treated with MGCD0103
MGCD0103, mg/m2 . | No. of patients . | No. patients with 1st cycle DLT . | NCI-CTCAE grade, no. of patients by worst grade—all cycles . | ||||
---|---|---|---|---|---|---|---|
0 . | 1 . | 2 . | 3 . | 4 . | |||
20 | 3 | 0 | 1 | 2 | 0 | 0 | 0 |
40 | 5 | 0 | 3 | 2 | 0 | 0 | 0 |
60 | 11 | 0 | 3 | 0 | 6 | 2 | 0 |
70 | 6 | 3 | 1 | 0 | 2 | 3 | 0 |
80 | 4 | 3 | 0 | 0 | 1 | 3 | 0 |
Total | 29 | 6 | 8 | 4 | 9 | 8 | 0 |
MGCD0103, mg/m2 . | No. of patients . | No. patients with 1st cycle DLT . | NCI-CTCAE grade, no. of patients by worst grade—all cycles . | ||||
---|---|---|---|---|---|---|---|
0 . | 1 . | 2 . | 3 . | 4 . | |||
20 | 3 | 0 | 1 | 2 | 0 | 0 | 0 |
40 | 5 | 0 | 3 | 2 | 0 | 0 | 0 |
60 | 11 | 0 | 3 | 0 | 6 | 2 | 0 |
70 | 6 | 3 | 1 | 0 | 2 | 3 | 0 |
80 | 4 | 3 | 0 | 0 | 1 | 3 | 0 |
Total | 29 | 6 | 8 | 4 | 9 | 8 | 0 |
Total number of treatment cycles in the study was 56; the median number of treatment cycles was 1 (range, 1-6). Other drug-related grade 3 nonhematologic toxicities occurring in 2 or fewer patients included gastrointestinal reflux disease in 2 patients and mucosal inflammation, abdominal distension, arthralgia, bacteremia, constipation, gastritis, hematuria, lower GI hemorrhage, and extremity pain occurring in 1 patient each. No grade 4 or 5 toxicities were reported.