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Reported dose-limiting toxicities
| Toxicity | Irinotecan dose, mg/m2 (no. of patients treated)
|
|||||
|---|---|---|---|---|---|---|
| 350 (6) | 400 (3) | 450 (3) | 500 (6) | 500 (12)* | 550 (2) | |
| Diarrhea | 0 | 0 | 0 | 1 | 0 | 1 |
| Granulocytopenia | 0 | 0 | 0 | 0 | 0 | 0 |
| Lymphocytopenia | 0 | 0 | 0 | 0 | 0 | 0 |
| Leukopenia | 0 | 0 | 0 | 0 | 0 | 0 |
| Nausea/vomiting | 1 | 0 | 0 | 0 | 0 | 1 |
NOTE: No instances of grade 4 toxicity were reported.
Expansion cohort of 12 patients accrued to further assess the irinotecan toxicity profile.
