Table 2.
Patient demographics, prior treatments, and antitumour activity by dose levels
| Patient no. | No. cycles | No. of prior regimens | Best response to last regimen/PFS (months) | Best response to current regimen/PFS (months) |
| Low-dose cohort | ||||
| 1 | 6 | 1 | PR/13.1 | SD/5.0 |
| 2 | 2 | 2 | SD/4.2 | PD |
| 3 | 2 | 4 | PD | PD |
| 4 | 6 | 3 | PD | SD/8.0 |
| 5 | 2 | 3 | SD/10.4 | PD |
| 6 | 2 | 2 | PD | PD |
| 7 | 6 | 4 | NA | SD/4.6 |
| 8 | 4 | 1 | SD/5.7 | PR/1.5 |
| 9 | 6 | 2 | PR/9.4 | SD/4.6 |
| 10 | 2 | 3 | SD/8.5 | PD |
| 11 | 2 | 3 | NA | PD |
| 12 | 4 | 4 | PD | SD/4.3 |
| High-dose cohort | ||||
| 1 | 2 | 2 | SD/7.1 | PD |
| 2 | 2 | 3 | PD | PD |
| 3 | 4 | 2 | PR/13.1 | SD/7.5 |
| 4 | 2 | 2 | PD | PD |
| 5 | 2 | 2 | PD | PD |
| 6 | 4 | 4 | SD/5.0 | SD/3.3 |
| 7 | 4 | 3 | SD/5.9 | SD/2.7 |
| 8 | 2 | 2 | PD | SD/1.6 |
| 9 | 2 | 0 | – | PD |
| 10 | 4 | 4 | PD | SD/3.2 |
| 11 | 1 | 2 | PD | PD |
| 12 | 6 | 0 | – | SD/5.7 |
Even though eligibility criteria required prior treatment with no more than three prior regimens, two patients (both in the high-dose cohort) who did not have previously received systemic therapy and five patients (three in the low-dose cohort and two in the high-dose cohort) who had previously received four regimens were, however, allowed to be enrolled and were included in the study analysis. Though measurable disease was not required by study protocol, all patients presented with at least one measurable target lesion according to RECIST criteria.
No. cycles, number of treatment cycles administered in the current study; PFS, progression-free survival; NA, not assessed; PD, progressive disease; SD, stable disease; PR, partial response.