Table 2.
Summary of Baseline Demographic and Disease Characteristics for All Enrolled Subjects
| |
n (%) |
||
|---|---|---|---|
| Parameter | GI-4000 + gemcitabine | Placebo + gemcitabine | Total |
| Age (years) | 63.4 | 60.8 | 62.1 |
| Gender | |||
| Women | 34 (38.6%) | 39 (44.3%) | 73 (41.5%) |
| Men | 54 (61.4%) | 49 (55.7%) | 103 (58.5%) |
| Race | |||
| White | 71 (80.7%) | 71 (80.7%) | 142 (80.7%) |
| African American | 7 (8.0%) | 7 (8.0%) | 14 (8.0%) |
| Asian | 4 (4.5%) | 4 (4.5%) | 8 (4.5%) |
| Hispanic | 6 (6.8%) | 5 (5.7%) | 11 (6.3%) |
| Other | 0 | 1 (1.1%) | 1 (0.6%) |
| ECOG performance status | |||
| Grade 0 | 22 (25.0%) | 22 (25.0%) | 44 (25.0%) |
| Grade 1 | 52 (59.1%) | 52 (59.1%) | 104 (59.1%) |
| Grade 2 | 8 (9.1%) | 6 (6.8%) | 14 (8.0%) |
| Grade 3 | 0 (0.0%) | 1 (1.1%) | 1 (0.6%) |
| Not reported | 6 (6.8%) | 7 (8.0%) | 13 (7.4%) |
| ras mutation | |||
| G12Va | 41 (46.6%) | 37 (42.0%) | 78 (44.3%) |
| G12C | 3 (3.4%) | 0 (0.0%) | 3 (1.7%) |
| G12D | 35 (39.8%) | 41 (46.6%) | 76 (43.2%) |
| G12R | 7 (8.0%) | 8 (9.1%) | 15 (8.5%) |
| Q61H | 2 (2.3%) | 2 (2.3%) | 4 (2.3%) |
| Primary tumor | |||
| T1 | 7 (8.0%) | 9 (10.2%) | 16 (9.1%) |
| T2 | 8 (9.1%) | 10 (11.4%) | 18 (10.2%) |
| T3 | 70 (79.5%) | 68 (77.3%) | 138 (78.4%) |
| T4 | 3 (3.4%) | 0 (0.0%) | 3 (1.7%) |
| Not reported | 0 (0.0%) | 1 (1.1%) | 1 (0.6%) |
| Regional lymph node status | |||
| N0 | 25 (28.4%) | 20 (22.7%) | 45 (25.6%) |
| N1 | 34 (38.6%) | 36 (40.9%) | 70 (39.8%) |
| N1a | 6 (6.8%) | 9 (10.2%) | 15 (8.5%) |
| N1b | 23 (26.1%) | 22 (25.0%) | 45 (25.6%) |
| Not reported | 0 (0.0%) | 1 (1.1%) | 1 (0.6%) |
| CA 19–9 (U/mL) postoperative | |||
| Number of subjects | 84 | 84 | 168 |
| Median | 24.9 | 16.1 | 18.8 |
| Normal | 59 (67.0%) | 63 (71.6%) | 122 (69.3%) |
| Abnormalb | 25 (28.4%) | 21 (23.9%) | 46 (26.1%) |
| Not reported | 4 (4.5%) | 4 (4.5%) | 8 (4.5%) |
a
G, glycine; C, cysteine; D, aspartic acid; R, arginine; Q, glutamine; H, histidine; L, leucine; V, valine.
b
CA 19-9 values >35 U/mL were classified as abnormal.
ECOG, Eastern Cooperative Oncology Group.