Table 1.
Patient demographics and baseline characteristics in Parts A and B
| Patients | ||||
|---|---|---|---|---|
| PK set | Full set | |||
| Part A (N = 11) | Part B (N = 9) | Part A (N = 18) | Part B (N = 12) | |
| Median age (range), years | 61 (48–70) | 63 (42–75) | 60 (45–70) | 62 (42–75) |
| Male:female, n:n | 6:5 | 5:4 | 10:8 | 5:7 |
| Race, n (%) | ||||
| White | 10 (90.9) | 9 (100) | 17 (94.4) | 11 (91.7) |
| Other | 1 (9.1) | 0 | 1 (5.6) | 1 (8.3) |
| Median weight (range), kg | 77 (53–115) | 81 (65–96) | 78 (53–115) | 80 (54–96) |
| WHO performance status, n (%) | ||||
| 0 | 5 (45.5) | 2 (22.2) | 6 (33.3) | 2 (16.7) |
| 1 | 6 (54.5) | 7 (77.8) | 12 (66.7) | 10 (83.3) |
| Extent of disease, n (%) | ||||
| Metastatic | 11 (100) | 9 (100) | 18 (100) | 12 (100) |
| Primary tumour site, n (%) | ||||
| Gastrointestinala | 7 (63.6) | 2 (22.2) | 10 (55.6) | 3 (25.0) |
| Lung | 0 | 4 (44.4) | 1 (5.6) | 4 (33.3) |
| Breast | 0 | 2 (22.2) | 1 (5.6) | 2 (16.7) |
| Otherb | 4 (36.4) | 1 (11.1) | 6 (33.3) | 3 (25.0) |
| Prior lines of chemotherapyc, n (%) | ||||
| 0 | 0 | 0 | 0 | 0 |
| 1 | 2 (18.2) | 2 (22.2) | 3 (16.7) | 2 (16.7) |
| ≥ 2 | 9 (81.8) | 7 (77.8) | 14 (77.8) | 9 (75.0) |
aIncludes colon, colorectal, small bowel, and rectal
bIncludes adrenal, bladder, liver, other, prostate
cInformation not available for one patient in the full set in each part