Table 3.
Comparison of phase I designs under dose-toxicity Scenario 2.
| Dose | DLT rate | Designs |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 3 + 3 | 3 + 3@9,2 | CS(40; 3,6,9) | CS(25; 5,11) | CS(35; 2,6) | CS(50; 1,3,5) | CS(50) | mTPI | mTPI2 | CRM | ||
| Proportion of recommended dose (MTD) dose levels (%) | |||||||||||
| 0 | 3 | 3 | 3 | 9 | 2 | 0 | 0 | 0 | 0 | 0 | |
| 1 | 0.05 | 10 | 13 | 9 | 24 | 8 | 2 | 2 | 1 | 0 | 0 |
| 2 | 0.10 | 18 | 22 | 16 | 31 | 14 | 4 | 4 | 7 | 5 | 3 |
| 3 | 0.15 | 21 | 24 | 19 | 23 | 22 | 6 | 6 | 20 | 21 | 9 |
| 4 | 0.20 | 20 | 21 | 21 | 10 | 22 | 9 | 10 | 29 | 28 | 19 |
| 5 | 0.25 | 18 | 13 | 20 | 3 | 19 | 17 | 21 | 28 | 28 | 32 |
| 6 | 0.35 | 9 | 4 | 11 | 0 | 11 | 31 | 36 | 14 | 17 | 29 |
| 7 | 0.50 | 2 | 0 | 1 | 0 | 2 | 26 | 20 | 1 | 2 | 8 |
| 8 | 0.75 | 0 | 0 | 0 | 0 | 0 | 4 | 1 | 0 | 0 | 0 |
| 9 | 0.90 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Proportion of patients treated (%) | |||||||||||
| 1 | 0.05 | 24 | 23 | 21 | 38 | 18 | 9 | 7 | 18 | 17 | 7 |
| 2 | 0.10 | 23 | 23 | 22 | 31 | 21 | 10 | 8 | 23 | 23 | 7 |
| 3 | 0.15 | 20 | 21 | 20 | 20 | 21 | 12 | 10 | 25 | 25 | 10 |
| 4 | 0.20 | 15 | 16 | 17 | 8 | 18 | 13 | 12 | 20 | 20 | 17 |
| 5 | 0.25 | 10 | 10 | 12 | 3 | 13 | 15 | 17 | 11 | 11 | 25 |
| 6 | 0.35 | 5 | 5 | 6 | 0 | 7 | 17 | 22 | 4 | 4 | 20 |
| 7 | 0.50 | 2 | 1 | 2 | 0 | 2 | 15 | 17 | 0 | 0 | 12 |
| 8 | 0.75 | 0 | 0 | 0 | 0 | 0 | 6 | 5 | 0 | 0 | 3 |
| 9 | 0.90 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 |
| Average number of patients | 18.7 | 23.3 | 24.9 | 24.6 | 17.7 | 15.6 | 22.6 | 21.0 | 21.0 | 21.0 | |
| Percent toxicity (%) | 18.1 | 17.5 | 17.2 | 12.9 | 18.4 | 30.5 | 31.3 | 14.8 | 14.8 | 27.5 | |