Table 3.
Number of patients experiencing toxicity during Cycle 2–4 (Schedule A) or Cycle 3–6 (Schedule B).
| No. of patients with toxicity (Grade 1 and 2 / 3 and 4) |
|||||||
|---|---|---|---|---|---|---|---|
| SJG 136 Dose Level |
Schedule A (Daily × 5)a |
Schedule B (Daily × 3) |
|||||
| Toxicity | µg/m2/day (No. patients) |
12 (n=1) |
24 (n=2) |
20 (n=1) |
25 (n=1) |
30 (n=2) |
35 (n=1) |
| Edema | 1/0 | 1/2 | 1/0 | n/o | 2/0 | 1/0 | |
| Weight gain | n/o | 4/0 | n/o | n/o | 2/0 | 1/0 | |
| Fatigue | 1/0 | 0/3 | 1/0 | n/o | 1/0 | 1/0 | |
| Anorexia | 1/0 | 2/0 | n/o | n/o | 1/0 | 1/0 | |
| Dyspnea | 1/0 | 1/2 | n/o | n/o | 2/0 | 0/1 | |
| Myalgias | 1/0 | 3/0 | n/o | n/o | 1/0 | n/o | |
| Liver transaminases (ALT/AST) | 1/0 | 1/2b | 0/1 | 1/0 | 1/0 | n/o | |
| Alk.Phosphatase | n/o | 1/1b | 1/0 | n/o | 1/0 | n/o | |
| Bilirubin | 1/0 | n/o | n/o | n/o | n/o | n/o | |
| Hypoalbuminemia | 2/0 | 2/0 | 1/0/ | n/o | 1/0 | n/o | |
| Hypophosphatemia | n/o | n/o | n/o | n/o | n/o | n/o | |
| Anemia | 1/0 | n/o | n/o | 1/0 | n/o | n/o | |
| Leukopenia | 1/0 | n/o | n/o | n/o | n/o | n/o | |
| Thrombocytopenia | 1/0 | n/o | n/o | n/o | n/o | n/o | |
a)
no patients on dose level 6 or 48 µg/m2/day received more than one cycle
b)
one patient experienced delayed onset of grade 3 and 4 elevation of ALT, AST and alkaline phosphatase, which started 60 days after the last dose and lasted for 3 months
n/o, no toxicity observed