Table 3 Tumor response based on investigator assessments
Best overall response | 12 mg (N = 15) | 15 mg (N = 3) | 18 mg(N = 3) | All doses(N = 42) |
|---|---|---|---|---|
n (%) | n (%) | n (%) | n (%) | |
CR, | 0 | 0 | 0 | 0 |
PR#, | 4 | 0 | 1 | 6 |
SD, | 6 | 3 | 1 | 24 |
ORR& (95%CI) | 26.7% (7.8, 55.1) | 0 (0.0) | 33.3% (0.8, 90.6) | 14.3% (5.4, 28.5) |
DCR (95%CI) | 86.7% (59.5, 98.3) | 100.0% (29.2, 100.0) | 66.7% (9.4, 99.2) | 78.6% (63.2, 89.7) |
DOR (months) (95% CI) | 2.9 (0.6, 5.5) | NA | / (/, /) | 3.6 (0.6, 6.2) |
PFS (months) (95% CI) | 3.6 (1.8, 5.5) | 4.8 (2.2, 4.8) | 7.6 (1.0, 7.6) | 3.0 (2.1, 3.7) |