Table 1.
Patient Demographic and Clinical Characteristics
| Characteristic | No. of Patients by Dose Level (mg/kg) |
|||||||
|---|---|---|---|---|---|---|---|---|
| Total (N = 47) | 0.3 (n = 3) | 1.0 (n = 7) | 2.0 (n = 6) | 3.0 (n = 7) | 4.0 (n = 7) | 5.0 (n = 4) | 7.0 (n = 13) | |
| Sex | ||||||||
| Male | 15 | 0 | 1 | 3 | 3 | 2 | 2 | 4 |
| Female | 32 | 3 | 6 | 3 | 4 | 5 | 2 | 9 |
| Age, years | ||||||||
| Median | 56 | 60 | 51 | 57.5 | 61 | 48 | 51.5 | 56 |
| Range | 36-78 | 57-65 | 39-58 | 48-73 | 36-74 | 44-68 | 36-78 | 42-72 |
| ECOG PS | ||||||||
| 0 | 19 | 3 | 2 | 2 | 2 | 4 | 1 | 5 |
| 1 | 26 | 0 | 5 | 4 | 5 | 3 | 3 | 6 |
| 2 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 2 |
| Prior chemotherapy regimens | ||||||||
| Median | 5 | 4 | 5.5 | 5 | 7 | 3 | 4 | 6 |
| Range | 1-13 | 4-5 | 3-11 | 1-13 | 2-11 | 1-7 | 1-9 | 3-10 |
| Tumor site | ||||||||
| Ovarian/fallopian/peritoneal | 14 | 2 | 0 | 3 | 1 | 1 | 2 | 5 |
| Renal | 7 | 0 | 1 | 2 | 0 | 3 | 1 | 0 |
| Colorectal | 7 | 0 | 0 | 0 | 2 | 3 | 0 | 2 |
| Biliary | 2 | 0 | 1 | 0 | 1 | 0 | 0 | 0 |
| Uterine | 4 | 1 | 3 | 0 | 0 | 0 | 0 | 0 |
| Other | 13 | 0 | 2 | 1 | 3 | 0 | 1 | 6 |
Abbreviation: ECOG PS, Eastern Cooperative Oncology Group performance status.