TABLE 1.
Baseline characteristics
| Phase I dose escalation N = 17 | Phase II dose expansion N = 30 | Total N = 47 | |
|---|---|---|---|
| Age, years | |||
| Median (range) | 63 (37–73) | 65 (42–74) | 64 (37–74) |
| ≥65 | 7 | 15 | 22 |
| Sex | |||
| Female | 9 | 11 | 20 |
| Male | 8 | 19 | 27 |
| Race | |||
| Asian | 1 | 1 | 2 |
| Black | 2 | 3 | 5 |
| White | 14 | 26 | 40 |
| Ashkenazi Jewish descent | 1 | 4 | 5 |
| ECOG | |||
| 0 | 4 | 11 | 15 |
| 1 | 13 | 19 | 32 |
| Baseline CA19-9 | |||
| Normal | 3 | 5 | 8 |
| Elevated | 14 | 25 | 39 |
| Primary tumor location on pancreas | |||
| Head/Neck/Uncinate | 8 | 14 | 22 |
| Body/Tail | 9 | 16 | 25 |
| Differentiation | |||
| Moderately | 4 | 13 | 17 |
| Poorly | 12 | 14 | 26 |
| Unknown | 1 | 3 | 4 |
| Site of metastases | |||
| Liver | 16 | 25 | 41 |
| Lung only | 0 | 0 | 0 |
| Baseline ascites | |||
| Yes | 4 | 7 | 11 |
| No | 13 | 23 | 36 |
| NLR | |||
| ≤5 | 13 | 23 | 36 |
| >5 | 4 | 7 | 11 |
Abbreviation: NLR, neutrophil lymphocyte ratio.