Demographic and baseline characteristics
| Dose verification (n=20) | PK substudy (n=57) | Phase 2 (n=223) | Total (N=300) | |
| Median age, years (range) | 49.5 (22–73) | 58.0 (18–82) | 57.0 (24–75) | 56.5 (18–82) |
| <65 | 15 (75) | 41 (72) | 167 (75) | 223 (74) |
| ≥65 | 5 (25) | 16 (28) | 56 (25) | 77 (26) |
| Gender | ||||
| Male | 16 (80) | 41 (72) | 150 (67) | 207 (69) |
| Female | 4 (20) | 16 (28) | 73 (33) | 93 (31) |
| ECOG performance status, n (%) | ||||
| 0 | 6 (30) | 14 (25) | 60 (27) | 80 (27) |
| 1 | 14 (70) | 43 (75) | 163 (73) | 220 (73) |
| Tumor stage | ||||
| Locally advanced | 0 | 7 (12) | 9 (4) | 16 (5) |
| Metastatic disease | 20 (100) | 50 (88) | 214 (96) | 284 (95) |
| Patients with prior anticancer drug therapy, n (%) | 18 (90) | 53 (93) | 217 (97) | 288 (96) |
| Regimens of prior anticancer treatment*, n (%) | ||||
| 1 | 3 (17) | 12 (23) | 69 (32) | 84 (29) |
| 2 | 4 (22) | 10 (19) | 60 (28) | 74 (26) |
| 3 | 6 (33) | 15 (28) | 42 (19) | 63 (22) |
| ≥4 | 5 (28) | 16 (30) | 46 (21) | 67 (23) |
| Time from initial diagnosis to study entrance, months (range) | 19.8 (1.0–149.1) | 21.5 (0.4–100.3) | 19.8 (0.5–189.5) | 19.9 (0.4–189.5) |
| Prior treatment received, n (%)* | ||||
| Cytotoxic therapy | 17 (94) | 49 (93) | 192 (89) | 258 (90) |
| TKI | 7 (39) | 11 (21) | 48 (22) | 66 (23) |
| Monoclonal antibodies | 3 (17) | 10 (19) | 32 (15) | 45 (16) |
| Median study follow-up duration, months (range) | 10.8 (0.7–21.9) | 8.0 (0.6–11.4) | 8.0 (0.2–18.5) | 8.1 (0.2–21.9) |
*Percentage based on patients receiving prior therapies.
ECOG, Eastern Cooperative Oncology Group; PK, pharmacokinetic; TKI, tyrosine kinase inhibitor.