Table 2.
Number of patients experiencing toxicity during Cycle 1 only (Schedule A) or Cycles 1 and 2 (Schedule B).
| No. of patients with toxicity (Grade 1 and 2 / 3 and 4) |
|||||||||
|---|---|---|---|---|---|---|---|---|---|
| SJG 136 Dose Level |
Schedule A (Daily × 5) |
Schedule B (Daily × 3) |
|||||||
| Toxicity | µg/m2/day (No. patients) |
6 (n=1) |
12 (n=1) |
24 (n=3) |
48 (n=2) |
20 (n=4)a |
25 (n=4)b |
30 (n=6) |
35 (n=2) |
| Edema | n/o | n/o | 3/0 | 1/1c | 1/0 | 1/0 | 4/1d | 2/0 | |
| Weight gain | n/o | n/o | n/o | 0/1c | n/o | n/o | 1/0 | 1/0 | |
| Fatigue | n/o | 1/0 | 3/0 | 2/0 | 3/0 | 2/0 | 4/0 | 0/1d | |
| Anorexia | n/o | 1/0 | 1/0 | 2/0 | 1/0 | 1/0 | 2/0 | 1/0 | |
| Dyspnea | n/o | n/o | 1/0 | 0/1c | n/o | n/o | n/o | 1/1d | |
| Myalgias | n/o | 1/0 | n/o | n/o | n/o | n/o | n/o | n/o | |
| Liver transaminases (ALT/AST) | n/o | 1/0 | 2/0 | 1/0 | 0/1 | 1/0 | n/o | 0/1d | |
| Alkaline phosphatase | n/o | n/o | 1/0 | n/o | 1/0 | n/o | n/o | 0/1d | |
| Bilirubin | n/o | 1/0 | n/o | 0/1c | n/o | n/o | n/o | n/o | |
| Hypoalbuminemia | n/o | n/o | 1/0 | 2/0 | 1/0 | n/o | 1/0 | 1/0 | |
| Hypophosphatemia | n/o | n/o | n/o | n/o | 1/0 | n/o | 1/1d | n/o | |
| Anemia | n/o | n/o | n/o | n/o | 1/0 | 1/0 | n/o | 1/0 | |
| Leukopenia | n/o | n/o | n/o | n/o | n/o | n/o | n/o | n/o | |
| Thrombocytopenia | n/o | n/o | n/o | n/o | n/o | n/o | n/o | n/o | |
a)
1 patient signed the consent but never received the treatment
b)
1 patient not evaluable due to disease progression after cycle 1
c)
DLT on Schedule A
d)
DLT on Schedule B
n/o, no toxicity observed; DLT, dose limiting toxicity