Table 7.
Dose-Limiting Toxicities Observed During Course 1 in Patients Receiving EMD 273063
| Dose (mg/m2) | Total Patients | Dose-Limiting Toxicity* and No. of Patients |
|---|---|---|
| 0.8 | 3 | None |
| 1.6 | 6 | AST, 1† |
| 3.2 | 6 | None |
| 4.8 | 6 | Thrombocytopenia, 1 |
| 6.0 | 6 | Hypoxia, 1 |
| 7.5§ | 6 | Hypoxia, 1; AST/ALT, 1‡; hypotension, 1; hyperglycemia, 1 |
*
Protocol amendments excluded the following grade 3 toxicities as dose-limiting toxicities; hyperglycemia in patients with known diabetes mellitus (patients with a known history of diabetes mellitus were excluded), hypophosphatemia, and hyperbilirubinemia.
†
Grade 3 elevation of AST.
‡
Grade 3 elevation of AST and ALT.
§
The dose of 7.5 mg/m2/d was found to be the maximum-tolerated dose, as two to six patients during course 1 showed reversible dose-limiting toxicity at this dose level (one patient with hypoxia, hypotension, and hyperglycemia and one patient with elevated AST/ALT).