Table 2.
DLTs and hematologic abnormalities in Caucasian patients during the MTD evaluation period
| Dose level (mg) | Treated patients | Evaluable patients | DLTs (n) | Severe hematologic abnormalities based on laboratory data (n) |
|---|---|---|---|---|
| 200 | 7a | 6 | Grade 3 oral herpes, stomatitis, and febrile neutropenia (1) | Grade 4 neutropenia, lymphopenia, thrombocytopenia, and/or leukopenia (5) |
| 150 | 6 | 6 | Grade 4 hypophosphatemia (2), Grade 3 hypokalemia and hypocalcemia (1) | Grade 4 neutropenia and/or leukopenia (4) |
| 100b | 6c | 6 | None | None |
| 3 | 4d | 3 | None | Grade 4 leukopenia and neutropenia |
DLTs dose-limiting toxicities, MTD maximum tolerated dose
aOne patient withdrew consent during the MTD evaluation period and was replaced
bDetermined to be the MTD
cThree patients in initial cohort plus three additional patients to determine the MTD
dOne patient was replaced because they were not evaluable for DLTs in the MTD evaluation period