Table 2 NUC-3373 treatment exposure
Characteristic | Part 1 Cohorts (Q1W) | ||||||||
125 mg/m2 (n = 4) | 250 mg/m2 (n = 7) | 500 mg/m2 (n = 8) | 750 mg/m2 (n = 4) | 1125 mg/m2 (n = 3) | 1500 mg/m2 (n = 3) | 1875 mg/m2 (n = 6) | 2500 mg/m2 (n = 7) | 3250 mg/m2 (n = 4) | |
Started treatment, n | 3 | 6 | 8 | 4 | 3 | 3 | 6 | 6 | 4 |
Did not start treatment, n | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
Median duration of exposure, weeks [range] | 7.3 [7.3, 8.1] | 4.8 [2, 7.7] | 8 [2, 16] | 7.5 [6.9, 11] | 18.9 [17, 48] | 15 [8.1, 41] | 8.7 [4.1, 16.3] | 8.1 [4.9, 16] | 9.9 [2.3, 17.9] |
Median completed cycles, n [range] | 2 [1.8, 2] | 1.1 [0.3, 2] | 1.9 [0.5, 4] | 1.9 [1.8, 2.5] | 4 [3.3, 11.8] | 3.5 [2, 9.3] | 2.1 [1, 4] | 2 [1.3, 4] | 2 [0.5, 4.3] |
Patients completing 6 cycles, n (%) | 0 | 0 | 0 | 0 | 1 (33.3) | 1 (33.3) | 0 | 0 | 0 |
Patients with a dose modification a, n (%) | 1 (33.3) | 5 (83.3) | 5 (62.5) | 3 (75) | 2 (66.7) | 2 (66.7) | 3 (50) | 5 (83.3) | 4 (100) |
Patients with a dose reduction, n (%) | 0 | 0 | 1 (12.5) | 2 (50) | 1 (33.3) | 0 | 1 (16.7) | 0 | 3 (75) |
Characteristic | Part 2 Cohorts (Q2W) | ||||||||
1500 mg/m2 (n = 4) | 1875 mg/m2 (n = 6) | 2500 mg/m2 (n = 6) | |||||||
Started treatment, n | 4 | 6 | 6 | ||||||
Did not start treatment, n | 0 | 0 | 0 | ||||||
Median duration of exposure, weeks [range] | 12.2 [6.9, 44.6] | 7.9 [6.3, 16.9] | 6.9 [3, 8.9] | ||||||
Median completed cycles, n [range] | 3 [1.5, 9.5] | 2 [1.5, 4] | 1.75 [0.5, 2] | ||||||
Patients completing 6 cycles, n (%) | 1 (25) | 0 | 0 | ||||||
Patients with a dose modification a, n (%) | 3 (75) | 2 (33.3) | 3 (50) | ||||||
Patients with a dose reduction, n (%) | 1 (25) | 0 | 0 | ||||||