Table 1 Demographics and baseline characteristics.
Variable | Day 1 and day 8 dosing | Day 1 dosing | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
Cohort 1 1.0 mg/m2 (N = 3) | Cohort 2 2.0 mg/m2 (N = 3) | Cohort 3 4.0 mg/m2 (N = 3) | Cohort 4 6.0 mg/m2 (N = 3) | Cohort 5 8.0 mg/m2 (N = 3) | Cohort 6 12.0 mg/m2 (N = 6) | Cohort 7 8.0 mg/m2 (N = 3) | Cohort 8 10.0 mg/m2 (N = 3) | Cohort 9 12.0 mg/m2 (N = 6) | Cohort 10 14.0 mg/m2 (N = 6) | Total (N = 39) | |
Females, n (%) | 1 (33.3) | 1 (33.3) | 3 (100.0) | 1 (33.3) | 0 | 1 (16.7) | 1 (33.3) | 3 (100.0) | 3 (50.0) | 3 (50.0) | 17 (43.6) |
Age | 3 | ||||||||||
Mean, year (SD) | 71.3 (2.08) | 64.3 (9.07) | 58.3 (17.21) | 53 (5.57) | 65 (8.89) | 68.3 (7.99) | 54.7 (13.65) | 60.7 (11.02) | 59.8 (11.36) | 68.2 (6.62) | 63.1 (10.25) |
Median, year | 72 | 68 | 64 | 54 | 68 | 67.5 | 57 | 66 | 60 | 68.5 | 67 |
Min, Max, year | 69, 73 | 54, 71 | 39, 72 | 47, 58 | 55, 72 | 55, 78 | 40, 67 | 48, 68 | 45, 75 | 59, 76 | 39, 78 |
Race | |||||||||||
African American, Black | 0 | 0 | 0 | 0 | 1 (33.3) | 1 (16.7) | 0 | 0 | 0 | 2 (33.0) | 4 (10.3) |
Caucasian, White | 2 (66.7) | 2 (66.7) | 3 (100) | 3 (100) | 1 (33.3) | 5 (83.3) | 3 (100) | 3 (100) | 4 (66.7) | 3 (100) | 29 (74.4) |
Other | 1 (33.3) | 1 (33.3) | 0 | 0 | 1 (33.3) | 0 | 0 | 0 | 2 (33.3) | 1 (16.7) | 6 (15.4) |
Ethnicity | |||||||||||
Hispanic, Latino | 0 | 1 (33.3) | 0 | 0 | 0 | 0 | 0 | 0 | 2 (33.3) | 0 | 3 (7.7) |
Non-Hispanic, Non-Latino | 3 (100) | 2 (66.7) | 3 (100) | 3 (100) | 3 (100) | 6 (100) | 3 (100) | 3 (100) | 4 (66.7) | 6 (100) | 36 (92.3) |
ECOG, n (%) | |||||||||||
0 | 0 | 0 | 1 (33.3) | 0 | 0 | 1 (16.7) | 2 (66.7) | 0 | 1 (16.7) | 2 (33.3) | 7 (17.9) |
1 | 3 (100.0) | 3 (100.0) | 2 (66.7) | 3 (100.0) | 3 (100.0) | 5 (83.3) | 1 (33.3) | 3 (100.0) | 5 (83.3) | 4 (66.7) | 32 (82.0) |
Tumor type, n (%) | |||||||||||
Breast | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (16.7) | 1 (2.6) |
Colorectal | 0 | 0 | 0 | 1 (33.3) | 0 | 0 | 0 | 0 | 1 (16.7) | 3 (50.0) | 5 (12.8) |
Hepatocellular carcinoma | 2 (66.7) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (16.7) | 0 | 3 (7.7) |
Lung | 0 | 0 | 1 (33.3) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (2.6) |
Melanoma | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (16.7) | 0 | 1 (2.6) |
Ovarian | 0 | 1 (33.3) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (2.6) |
Prostate | 0 | 2 (66.7) | 0 | 0 | 1 (33.3) | 3 (50.0) | 2 (66.7) | 0 | 0 | 0 | 8 (20.5) |
Squamous cell carcinoma | 0 | 0 | 0 | 0 | 2 (66.7) | 0 | 0 | 0 | 0 | 0 | 2 (5.1) |
Other | 1 (33.3) | 0 | 2 (66.7) | 2 (66.7) | 0 | 3 (50.0) | 1 (33.3) | 3 (100.0) | 3 (50.0) | 2 (33.3) | 17 (43.6) |
Stage, n (%) | |||||||||||
Stage 3 | 0 | 1 (33.3) | 0 | 0 | 0 | 0 | 0 | 0 | 1 (16.7) | 0 | 2 () |
Stage 4 | 3 (100.0) | 2 (66.7) | 3 (100.0) | 3 (100.0) | 3 (100.0) | 6 (100.0) | 3 (100.0) | 3 (100.0) | 5 (83.3) | 6 (100.0) | 37 (94.9) |
