Table 6.
Best tumor responses
| Part 1 | Part 2 | Total | |
|---|---|---|---|
| Response category, n (%) | N = 6 | N = 6 | N = 12 |
| Best tumor response, n (%) | |||
| CR | 0 | 0 | 0 |
| PR | 1 (16.7) | 0 | 1 (8.3) |
| SD (including non-CR/non-PD) | 4 (66.7) | 6 (100.0) | 10 (83.3) |
| PD | 1 (16.7) | 0 | 1 (8.3) |
| Not evaluable | 0 | 0 | 0 |
| Objective response rate | 1 (16.7) | 0 | 1 (8.3) |
| 95 % CI | 0.4, 64.1 | 0.0, 45.9 | 0.2, 38.5 |
| Disease Control Rate | 5 (83.3) | 5 (83.3) | 10 (83.3) |
| 95 % CI | 35.9, 99.6 | 35.9, 99.6 | 51.6, 97.9 |
| Clinical Benefit Rate | 4 (66.7) | 2 (33.3) | 6 (50.0) |
| 95 % CI | 22.3, 95.7 | 4.3, 77.7 | 21.1, 78.9 |
CI confidence interval, CR complete response, PR partial response, SD stable disease, PD progressive disease