Table 2.
Dose-escalation schemes
| Dose-escalation schemes |
||||
| Dose level, mg q.i.d. | Patients, n | Number of days on treatmenta, range | Number of patients with DLT in cycle 1 | |
| Study 1: weekly dosing | 10 | 3 | 36–106 | 0 |
| 20 | 3 | 51–106 | 0 | |
| 40 | 4 | 8–58 | 0 | |
| 60 | 6 | 1–141 | 0 | |
| 90 | 3 | 50–106 | 0 | |
| Study 2: 14 days continuous dosing, 1 week rest | 5 | 3 | 55–77 | 0 |
| 10 | 3 | 55–98 | 0 | |
| 20 | 3 | 55–119 | 0 | |
| 40 | 8 | 5–161 | 2 (G2 nausea and vomiting; G5 acute renal failure) | |
| Study 3: continuous dosing | 2.5 | 3 | 35–56 | 0 |
| 5 | 3 | 29–56 | 0 | |
| 10 | 5 | 19–87 | 0 | |
| 20 | 11 | 1–226 | 0 | |
| 40 | 6 | 3–56 | 2 (fatal pericarditis; G3 fatigue) | |
Period from first to last dose of AZD5438 treatment.
DLT, dose-limiting toxicity.