Table 4. Response for phase I/II.
Dose level | n | CR | PR | SD | PD | NE | ORR (%) |
---|---|---|---|---|---|---|---|
Phase 1 | |||||||
Level 1 | 3(2) | — | 1(1) | 2(1) | 0 | 0 | 33.3 |
Level 2 | 6(3) | — | 4(3) | 1(0) | 0 | 1(0) | 67.8 |
Level 3 | 3(1) | — | 2(1) | 0 | 1(0) | 0 | 67.8 |
Level 4 | 6(1) | — | 5(0) | 0 | 1(1) | 0 | 83.3 |
Total | 18(7) | — | 12(5) | 3(1) | 2(1) | 1(0) | 70.6 |
Phase II | 20(0) | 1(0) | 11(0) | 6(0) | 2(0) | 0(0) | 55.0 |
Phase I/II | 38(7) | 1(0) | 23(5) | 9(1) | 2(1) | 1(0) | 62.1 |
(): number of pretreated patients, n=number of patients, CR=complete response, PR=partial response, SD=stable disease, PD=progression disease, NE=not evaluable, ORR=objective response rate.