Table 3 Anti-tumour activity of NUC-1031
n in dose cohort | NUC-1031 dose mg/m2 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
500 | 625 | 675 | 725 | 2 × 375a | 750 | 825 | 900 | 1000 | |
(2) | (2) | (1) | (5) | (5) | (7) | (12) | (11) | (4) | |
Complete response - n | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Partial response (PR) - n (95% CI) | 0 | 1 (9.5,90.5) | 0 | 0 | 0 | 3 (15.8,75.0) | 0 | 0 | 1 (4.6,69.9) |
Confirmed PR - n (%) | NA | 0 | NA | NA | NA | 2 (28.6) | NA | NA | NA |
Stable disease - n | 2 | 1 | 0 | 5 | 5 | 2 | 9 | 6 | 3 |
(95% CI) | (34.2,100.0) | (9.5,90.5) | (56.6,100.0) | (37.6,96.4) | (8.2,64.1) | (46.8,91.1) | (28.0,78.) | (30.1,95.4) | |
Progressive disease - n | 0 | 0 | 1 | 0 | 0 | 2 | 3 | 5 | 0 |
Disease control rate - n (%) | 2 (100) | 2 (100) | 0 | 5 (100) | 5 (100) | 5 (71.4) | 9 (75) | 6 (54.5) | 4 (100) |
Progression-free survival (months) | |||||||||
Censored, n | 2 | 2 | 0 | 2 | 2 | 3 | 5 | 2 | 2 |
Events, n | 0 | 0 | 1 | 3 | 3 | 4 | 7 | 9 | 2 |
Mean (SD) | 9.2 (3.09) | 5.2 (1.12) | 1.8 | 4.0 (2.32) | 3.2 (2.73) | 7.7 (8.36) | 3.6 (1.83) | 3.6 (1.77) | 5.5 (2.72) |
Median | 9.2 | 5.2 | 1.8 | 3.5 | 3.1 | 5.3 | 3.3 | 3.7 | 5.2 |
Range | 7.0–11.3 | 4.4–6.0 | NA | 1.6–7.9 | 0.5–7.5 | 1.5–25.0 | 1.6–8.3 | 1.5–7.1 | 2.8–8.8 |
