TABLE 2.
Dose-level summary with DLTs
| Dose level | Dose | Mean/median number of doses administered | DLT count (%) and number of patients | DLTs |
|---|---|---|---|---|
| 1 | 150 mg | 22.2/21 | 1 of 8 (12.5%) | Grade 3 fatigue |
| 2 | 300 mg | 22.7/21 | 0 of 3 (0.0%) | |
| 3 | 600 mg | 17.9/13.5 | 0 of 8 (0.0%) | |
| 4 | 900 mg | 6.5/6.5 | 2 of 2 (100%) | Grade 3 alanine aminotransferase elevation (N = 1) Grade 3 dyspnea/ flank pain (N = 1) |
Note: Four patients, 2 each at dose levels 150 and 600 mg, missed more than 25% of the first 4 weeks of treatments. Therefore, 2 additional patients were recruited for each dose level.
Abbreviations: DLT: dose-limiting toxicity.