Table 1 Demographic and baseline characteristics (safety analysis set)
Characteristics | Part 1a n = 67 | Parts 2 and 3b n = 25 | Total n = 92 |
|---|---|---|---|
Female, n (%) | 31 (46.3) | 11 (44.0) | 42 (45.7) |
Male, n (%) | 36 (53.7) | 14 (56.0) | 50 (54.3) |
Age, years | |||
Median (range) | 58.0 (24–77) | 46.0 (30–73) | 56.5 (24–77) |
<65, n (%) | 53 (79.1) | 22 (88.0) | 75 (81.5) |
≥65, n (%) | 14 (20.9) | 3 (12.0) | 17 (18.5) |
Race | |||
White | 49 (73.1) | 19 (76.0) | 68 (73.9) |
African American | 3 (4.5) | 5 (20.0) | 8 (8.7) |
Asian | 13 (19.4) | 0 (0) | 13 (14.1) |
Other | 2 (3.0) | 1 (4.0) | 3 (3.3) |
Weight, kg, median (range) | 72.0 (47.0–119.0) | 81.0 (56.0–121.0) | 73.0 (47.0–121.0) |
BMI, kg/m2, median (range) | 25.7 (17.1–48.7) | 27.3 (22.5–42.2) | 26.2 (17.1–48.7) |
ECOG performance status, n (%) | |||
0 | 45 (48.9) | ||
1 | — | — | 47 (51.1) |
Prior oncology medications, n (%) | |||
0 | — | — | 2 (2.2) |
1 | — | — | 16 (17.4) |
2 | — | — | 27 (29.3) |
≥3 | — | — | 47 (51.1) |
Gemcitabine | — | — | 21 (22.8) |
Oxaliplatin | — | — | 19 (20.7) |
Paclitaxel | — | — | 19 (20.7) |
Tumour type, n (%) | |||
Breast | — | — | 9 (10.6) |
Colorectal | — | — | 10 (10.9) |
Gastric | — | — | 20 (23.5) |
Ovarian | — | — | 9 (10.6) |
Pancreatic | — | — | 14 (16.5) |
Other | — | — | 30 (32.6) |
