Table 2.

Efficacy.

Variable	Outcome
Primary endpoint
PFS (n = 26)
6-month PFS 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)
FAS (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)
OS (n = 26)
Median (95% CI), months	6.7 (4.2–11.7)

Note: Full Analysis Set (FAS; n = 26) unless otherwise stated.

^aPatients with measurable lesions at baseline and who were reassessed during treatment.