Table 2.
Efficacy
| Variable | Outcome |
|---|---|
| Primary endpoint | |
| Progression-free survival (n = 26) | |
| 6-month progression-free survival rate (95% CI), % | 16.0 (5.0–32.5) |
| Median (95% CI), months | 1.7 (1.1–2.8) |
| Secondary endpoints | |
| Best response | |
| Efficacy analysis set (n = 21), n (%) a | |
| Objective response rate | 1 (4.8) |
| (95% CI) | (0.1–23.8) |
| Partial response | 1 (4.8) |
| Stable disease | 6 (28.6) |
| Progressive disease | 13 (61.9) |
| Full analysis set (n= 26), n (%) | |
| Objective response rate | 1 (3.8) |
| (95% CI) | (0.1–19.6) |
| Partial response | 1 (3.8) |
| Stable disease | 6 (23.1) |
| Progressive disease | 15 (57.7) |
| Unknown/missing | 4 (15.4) |
| Overall survival (n = 26) | |
| Median (95% CI), months | 6.7 (4.2–11.7) |
a
Patients with measurable lesions at baseline and who were re-assessed during treatment.
Abbreviation: CI, confidence interval.
Note: Full analysis set (n = 26) unless otherwise stated.