Table 3.

Efficacy results

	ITT population (N = 47)
Best objective response
Overall response rate, %	6.4
Complete response, n (%)	1 (2.1)
Partial response, n (%)	2 (4.3)
Stable disease, n (%)	21 (45)
Progression disease, n (%)	13 (28)
Disease control rate, n %	24 (51)
Non-evaluable, n %	10 (21)
Progression free survival (months), median (95%CI)	5.6 (2.7–8.4)
Progression free survival, rate at 6 months (95%CI)	45% (30–60)
Overall survival (months), median (95%CI)	16 (7.8–24)
Time to treatment failure (months), median (95%CI)	2.1 (1.3–2.9)
Time to progression (months), median (95%CI)	5.6 (1.9–9.3)

*N = 21 for stable disease analysis; Disease control rate = Overall response rate + stable disease rate