Table 1. Baseline Characteristics of All Treated Patients.
Characteristic | Dose Level 1 (40 mg BID) | Dose Level 2 (80 mg BID) | Dose Level 3 (120 mg BID) | Dose Level 4 (160 mg BID) | All Dose Levels |
---|---|---|---|---|---|
N = 3 | N = 6 | N = 6 | N = 7 | N = 22 | |
Age – yr | |||||
Median | 65 | 57 | 59 | 56 | 58 |
Range | 62-86 | 50-75 | 40-78 | 42-74 | 40-86 |
Sex – no (%) | |||||
Male | 2 (66) | 0 | 3 (50) | 3 (43) | 8 (36) |
Female | 1 (33) | 6 (100) | 3 (50) | 4 (57) | 14 (63) |
Ethnicity –no (%) | |||||
Caucasian | 1 (33) | 5 (83) | 4 (66) | 5 (71) | 15 (68) |
African American | 2 (66) | 1 (17) | 3 (14) | ||
Asian | 0 | 0 | 1 (17) | 1 (14) | 2 (9) |
Hawaiian/Pacific Islander | 0 | 0 | 0 | 1 (14) | 1 (4) |
Mixed Race | 0 | 0 | 1 (17) | 0 | 1 (4) |
ECOG performance status – no (%) | |||||
0 | 0 | 0 | 3 (50) | 2 (29) | 5 (23) |
1 | 3 (100) | 6 (100) | 3 (50) | 5 (71) | 17 (77) |
Primary Site of Disease –no (%) | |||||
Colon | 1 (33) | 0 | 0 | 3 (43) | 4 (18) |
Ovary | 0 | 4 (66) | 2 (33) | 1 (14) | 7 (32) |
Peritoneal Mesothelioma | 1 (33) | 0 | 0 | 0 | 1 (4) |
Peritoneal low-grade adenomucinous | 1 (33) | 0 | 0 | 0 | 1 (4) |
Urachus | 0 | 1 (17) | 0 | 0 | 1 (4) |
Pancreas | 0 | 1 (17) | 0 | 0 | 1 (4) |
Stomach | 0 | 0 | 1 (17) | 0 | 1 (4) |
Appendix | 0 | 0 | 1 (17) | 0 | 1 (4) |
Fallopian Tube | 0 | 0 | 1 (17) | 0 | 1 (4) |
Small Bowel | 0 | 0 | 1 (17) | 0 | 1 (4) |
Duodenum | 0 | 0 | 0 | 1 (14) | 1 (4) |
Cholangiocarcinoma | 0 | 0 | 0 | 2 (29) | 2 (9) |
Disease Stage –no (%) | |||||
II | 0 | 0 | 1 (17) | 0 | 1 (4) |
III | 0 | 0 | 0 | 1 (14) | 1 (4) |
IV | 3 (100) | 6 (100) | 5 (83) | 3 (43) | 17 (77) |
Unknown | 0 | 0 | 0 | 3 (43) | 3 (14) |
Prior Therapies - no | |||||
1 | 2 (66) | 3 (50) | 1 (17) | 2 (29) | 8 (36) |
2-3 | 0 | 0 | 3 (50) | 5 (71) | 8 (36) |
4 or more | 1 (33) | 3 (50) | 2 (33) | 0 | 6 (27) |