Best overall response
| . | Phase 1 . | Phase 2 . | Phase 1-2 . | |||
|---|---|---|---|---|---|---|
| 45 mg/m2 (n = 3) . | 56 mg/m2 (n = 3) . | 70 mg/m2 (n = 15) . | 88 mg/m2 (n = 6) . | 70 mg/m2 (n = 89) . | 70 mg/m2 (n = 104) . | |
| Stringent CR, n (%) | 0 | 1 (33) | 1 (7) | 1 (17) | 2 (2) | 3 (3) |
| CR, n (%) | 0 | 2 (67) | 4 (27) | 1 (17) | 7 (8) | 11 (11) |
| Very good PR, n (%) | 0 | 0 | 3 (20) | 0 | 31 (35) | 34 (33) |
| PR, n (%) | 1 (33) | 0 | 6 (40) | 2 (33) | 26 (29) | 32 (31) |
| Minimal response, n (%) | 1 (33) | 0 | 1 (7) | 1 (17) | 6 (7) | 7 (7) |
| Stable disease, n (%) | 1 (33) | 0 | 0 | 0 | 12 (13) | 12 (12) |
| Progressive disease, n (%) | 0 | 0 | 0 | 0 | 2 (2) | 2 (2) |
| Not evaluable, n (%) | 0 | 0 | 0 | 1 (17) | 3 (3) | 3 (3) |
| ORR, % (95% CI) | 33 | 100 | 93 | 67 | 74 | 77 (68-85) |
| CBR, % (95% CI) | 67 | 100 | 100 | 83 | 81 | 84 (75-90) |
| . | Phase 1 . | Phase 2 . | Phase 1-2 . | |||
|---|---|---|---|---|---|---|
| 45 mg/m2 (n = 3) . | 56 mg/m2 (n = 3) . | 70 mg/m2 (n = 15) . | 88 mg/m2 (n = 6) . | 70 mg/m2 (n = 89) . | 70 mg/m2 (n = 104) . | |
| Stringent CR, n (%) | 0 | 1 (33) | 1 (7) | 1 (17) | 2 (2) | 3 (3) |
| CR, n (%) | 0 | 2 (67) | 4 (27) | 1 (17) | 7 (8) | 11 (11) |
| Very good PR, n (%) | 0 | 0 | 3 (20) | 0 | 31 (35) | 34 (33) |
| PR, n (%) | 1 (33) | 0 | 6 (40) | 2 (33) | 26 (29) | 32 (31) |
| Minimal response, n (%) | 1 (33) | 0 | 1 (7) | 1 (17) | 6 (7) | 7 (7) |
| Stable disease, n (%) | 1 (33) | 0 | 0 | 0 | 12 (13) | 12 (12) |
| Progressive disease, n (%) | 0 | 0 | 0 | 0 | 2 (2) | 2 (2) |
| Not evaluable, n (%) | 0 | 0 | 0 | 1 (17) | 3 (3) | 3 (3) |
| ORR, % (95% CI) | 33 | 100 | 93 | 67 | 74 | 77 (68-85) |
| CBR, % (95% CI) | 67 | 100 | 100 | 83 | 81 | 84 (75-90) |