Table 2. Tumor response and disease stabilization (evaluable population).
| Intermittent 5/9 dosing cohort (n = 44) | Daily dosing cohort (n = 25) | |
| Subjects achieving best overall response of: | ||
| SD, n (%) | 10 (22.7) | 5 (20.0) |
| Progressive disease, n (%) | 34 (77.3) | 20 (80.0) |
| ORR | ||
| n (%) | 0 | 0 |
| 95% confidence intervala | 0.0–8.0 | 0.0–13.7 |
| Disease stabilization rate | ||
| n (%) | 10 (22.7) | 5 (20.0) |
| 95% confidence intervala | 11.5–37.8 | 6.8–40.7 |
Denominators for percentages are n, the total number of subjects in each dosing cohort. Best overall response was assessed by the investigator per RECIST. The ORR was defined as the percentage of subjects achieving best overall response of confirmed CR or PR. Disease stabilization rate was defined as the proportion of subjects achieving best overall response of confirmed CR or PR or SD.
a
Exact confidence intervals were obtained using the Clopper-Pearson method.