Table 1.
Patient demographics and disease characteristics (safety analysis set)
| Characteristic | Safety analysis set (N = 33) |
|---|---|
| Age, years | |
| Mean (SD) | 60.3 (8.8) |
| Median (range) | 60 (41–83) |
| Age group, n (%) | |
| 40– < 50 years | 5 (15.2) |
| 50– < 65 years | 20 (60.6) |
| ≥ 65 years | 8 (24.2) |
| Sex, n (%) | |
| Male | 15 (45.5) |
| Female | 18 (54.5) |
| Race, n (%) | |
| Asian | 1 (3.0) |
| Black or African American | 4 (12.1) |
| White | 28 (84.8) |
| Body mass index, kg/m2 | |
| n | 29 |
| Mean (SD) | 25.8 (4.9) |
| Median (range) | 25.0 (17.5–36.9) |
| ECOG performance status, n (%) | |
| (0) Normal activity | 15 (45.5) |
| (1) Restricted activity | 18 (54.5) |
| Primary tumor location, n (%)a | |
| Pancreas | 5 (15.2) |
| Colon | 4 (12.1) |
| Breast | 3 (9.1) |
| Lung | 3 (9.1) |
| Ovary | 3 (9.1) |
| Peritoneum | 3 (9.1) |
| Otherb | 12 (36.4) |
ECOG performance status and overall disease classification are based on assessments at baseline. Primary tumor location and histology type are based on assessments at primary diagnosis. aAll patients enrolled in this study had disease progression to unresectable recurrent/metastatic cancers since diagnosis. bOther includes appendix, cervix uteri, gastric cardia, head and neck, head and neck – oral cavity, larynx, pancreatic head, prostate gland, rectum, small intestine, submandibular gland, and uterus (all n = 1). ECOG Eastern Cooperative Oncology Group, SD standard deviation