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Efficacy.
| Variable | Phase I | Phase II |
|---|---|---|
| Best response | ||
| Evaluable | 8 | 25 |
| Complete response | 0 | 0 |
| Partial response | 1 | 1 |
| Stable disease | 3 | 12 |
| Progressive disease | 4 | 12 |
| TTP and Survival | ||
| Evaluable | 30 | 30 |
| Median TTP, months | 4.2 (95% CI: 1.9 – ∞) | 4.7 (95% CI: 3.1 – 9.3) |
| Median OS, months | 11.6 (95% CI: 6.0 – 52) | 9.6 (95% CI: 6.6 – 19.1) |
| 1-year survival, percent | 50 (30% standard error) | 47 (9% standard error) |
Abbreviations: TTP, time-to-progression; OS, overall survival; CI, confidence interval.
