Table 1 Patient demographics and baseline characteristics in the total dose-escalation and dose-expansion populations.
Dose escalation (n = 64) | Dose expansion (n = 37) | Total (N = 101) | |
|---|---|---|---|
Sex, n (%) | |||
Female | 51 (79.7) | 29 (78.4) | 80 (79.2) |
Male | 13 (20.3) | 8 (21.6) | 21 (20.8) |
Age, years | |||
Median (range) | 59.5 (37–83) | 60.0 (37–81) | 60.0 (37–83) |
Group, n (%) | |||
<65 | 42 (65.6) | 26 (70.3) | 68 (67.3) |
≥65 | 22 (34.4) | 11 (29.7) | 33 (32.7) |
ECOG status, n (%) | |||
0 | 22 (34.4) | 15 (40.5) | 37 (36.6) |
1 | 41 (64.1) | 22 (59.5) | 63 (62.4) |
2a | 1 (1.6) | 0 (0) | 1 (1.0) |
Race, n (%) | |||
Asian | 6 (9.4) | 2 (5.4) | 8 (7.9) |
White | 57 (89.1) | 34 (91.9) | 91 (90.1) |
Other | 1 (1.6) | 1 (2.7) | 2 (2.0) |
Median time from initial diagnosis to study entry, year (range) | 3.38 (0.4–22.1) | 2.80 (0.6–20.4) | 3.22 (0.4–22.1) |
Type of solid tumour, n (%) | |||
Adenocarcinoma or cancer unknown primaryb | 2 (3.1) | 0 (0) | 2 (2.0) |
Breast | 5 (7.8) | 2 (5.4) | 7 (6.9) |
Cervix | 0 (0) | 1 (2.7) | 1 (1.0) |
Chondrosarcoma | 2 (3.1) | 0 (0 0) | 2 (2.0) |
Fallopian tube | 4 (6.3) | 1 (2.7) | 5 (5.0) |
Glioblastoma | 3 (4.7) | 0 (0) | 3 (3.0) |
Gastric | 1 (1.6) | 0 (0) | 1 (1.0) |
Leiomyosarcoma | 1 (1.6) | 0 (0) | 1 (1.0) |
Mesothelioma | 0 (0) | 1 (2.7) | 1 (1.0) |
Non-small-cell lung cancer | 1 (1.6) | 0 (0) | 1 (1.0) |
Ovarian | 33 (51.6) | 23 (62.2) | 56 (55.4) |
Pancreatic | 2 (3.1) | 0 (0) | 2 (2.0) |
Peritoneal | 1 (1.6) | 1 (2.7) | 2 (2.0) |
Prostate | 5 (7.8) | 7 (18.9) | 12 (11.9) |
Small-cell lung cancer | 3 (4.7) | 1 (2.7) | 4 (4.0) |
Uterine | 1 (1.6) | 0 (0) | 1 (1.0) |
