Table 1.
Starting dose escalation plan
| Phase 1B cohort No. |
Cohort size n |
Lovastatin dose every 6 h for 72 h mg/kg/day |
Maximum dose, based on dose calculated for weight of 100 kg mg |
Dose days 3–30 mg/day |
|---|---|---|---|---|
| 1 | 3 | 1 | 100 | 20 |
| 2 | 3 | 3 | 300 | 20 |
| 3 | 6 | 6 | 600 | 20 |
| 4 | 9 | 8 | 800 | 20 |
| 5 | 12 | 10 | 1,000 | 20 |
| Total | 33 |
These dose levels applied before any dose-limiting toxicity was observed. The Data and Safety Monitoring Committee met to discuss continuation to the next cohort after every 3 patients were enrolled. Dose (de-)escalation was conducted according to the time-to-event CRM once a dose-limiting toxicity was observed.