Table 8.
Results of Phase I pharmacokinetic study and toxicity of Genexol-PM in cancer patients [26].
| Pharmacokinetics of Genexol-PM | |||||
|---|---|---|---|---|---|
|
| |||||
| Pharmacokinetics of paclitaxelb | |||||
|
| |||||
| Dose (mg/m2)a | N | AUC (h·μM) | Cmax(μM) | t1/2 (h) | CLtotal (L/h/m2) |
| 135 | 3 | 6.4 ± 1.5 | 1.6 ± 0.3 | 12.7 ± 4.2 | 25.5 ± 5.3 |
| 175 | 3 | 6.7 ± 1.6 | 1.7 ± 0.2 | 12.5 ± 2.5 | 32.0 ± 8.8 |
| 230 | 6 | 22.8 ± 4.7 | 5.5 ± 1.8 | 11.0 ± 1.9 | 12.1 ± 2.5 |
| 300 | 6 | 13.6 ± 5.0 | 3.6 ± 1.7 | 11.4 ± 2.4 | 29.3 ± 13.8 |
| 390 | 3 | 32.2 ± 9.7 | 7.7 ± 1.3 | 17.9 ± 1.0 | 14.9 ± 4.5 |
| Toxicity of Genexol-PM | |||||||
|---|---|---|---|---|---|---|---|
|
| |||||||
| Grade 3 or greater | |||||||
|
| |||||||
| Dose (mg/m2)a | N | Hematological toxicities | Neuromuscular toxicities | ||||
|
| |||||||
| Anemia | Neutropenia | Thrombocytopenia | Neuropathymotor | Neuropathysensory | Myalgia | ||
| 135 | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| 175 | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| 230 | 6 | 0 | 2 | 0 | 0 | 0 | 1 |
| 300 | 6 | 0 | 3 | 0 | 0 | 0 | 1 |
| 390 | 3 | 0 | 1 | 0 | 1 | 2 | 0 |
a
As paclitaxel equivalents.
b
Pharmacokinetics of polymer-drug micelles was determined during the first course.