Table 3 Main efficacy outcomes overall and at the recommended phase II dose
Recommended phase II dose | Entire study cohort | |||||
|---|---|---|---|---|---|---|
N | % | 95% CI | N | % | 95% CI | |
Objective response at 2 cycles | 1/14 | 7% | 0–34% | 2/28 | 7% | 1–24% |
Non-progression at 2 cycles | 8/14 | 57% | 29–82% | 12/28 | 43% | 24–63% |
Growth modulation index≥1.3 | 4/14 | 29% | 8–58% | 7/27 | 26% | 11–46% |
Median progression-free survival (months) | N = 14 | 2.9 m | 1.5–5.1 | N = 28 | 2.1 m | 1.6–3.7 |
Median overall survival (months) | N = 14 | 6.8 m | 3.7–11.1 | N = 28 | 8.2 m | 5.1–11.7 |