Table 3. Best response, overall survival, and time to progression.
|
Phase I
|
Phase II
|
|||
|---|---|---|---|---|
| Efficacy variables | Cohort 1 (n=3) | Cohort 2a (n=15) | Totalb (N=18) | Total (N=83) |
| Best response | ||||
| Patients not evaluable, n (%) | 0 | 1 (7) | 1 (6) | 8 (10) |
| CR | ||||
| n (%) | 0 | 0 | 0 | 1 (1) |
| 95% CI | 0, 7 | |||
| PR | ||||
| n (%) | 1 (33) | 2 (13) | 3 (17) | 9 (11) |
| 95% CI | 1, 91 | 2, 41 | 4, 41 | 5, 20 |
| SD | ||||
| n (%) | 2 (67) | 9 (60) | 11 (61) | 31 (37) |
| 95% CI | 9, 99 | 32, 84 | 36, 83 | 27, 49 |
| Progressive disease | ||||
| n (%) | 0 | 3 (20) | 3 (17) | 34 (41) |
| 95% CI | 4, 48 | 4, 41 | 30, 52 | |
| Overall best response rate (CR+PR) | ||||
| n (%) | 1 (33) | 2 (13) | 3 (17) | 10 (12) |
| 95% CI | 1, 91 | 2, 41 | 4, 41 | 6, 21 |
| Overall survival | ||||
| Patients not evaluable, n (%) | 0 | 0 | 0 | 0 |
| Censorship rate, % | 0 | 20 | 17 | 20 |
| Median, weeks | 30.1 | 23.1 | 26.1 | 37.0 |
| 95% CI | 26.1, 35.6 | 17.0, 32.6 | 17.3, 31.7 | 33.9, 46.0 |
| Time to progression | ||||
| Patients not evaluable, n (%) | 0 | 1 (7) | 1 (6) | 5 (6) |
| Censorship rate, % | 0 | 29 | 24 | 8 |
| Median, weeks | 22.7 | 13.0 | 13.0 | 14.6 |
| 95% CI | 11.3, 33.6 | 11.3, 19.6 | 11.3, 19.6 | 12.6, 19.9 |
Abbreviations: CI=confidence interval; CR=complete response; PR=partial response; SD=stable disease.
a
Includes cohort 2 and expansion cohort 2.
b
Response rate (%) and 95% CI based on intent-to-treat patients.