Table 1.
Baseline characteristics (Safety analysis set)
| Characteristic | Treatment cohort | ||
|---|---|---|---|
| 0.25 mg BID | 0.50 mg BID | Overall | |
| (n = 3) | (n = 12) | (n = 15) | |
| Median age in years | 63 | 64 | 63 |
| (range) | (56–64) | (41–73) | (41–73) |
| Gender | |||
| Male | 1 (33.3) | 6 (50.0) | 7 (46.7) |
| Female | 2 (66.7) | 6 (50.0) | 8 (53.3) |
| ECOG performance status | |||
| 0 | 2 (66.7) | 8 (66.7) | 10 (66.7) |
| 1 | 1 (33.3) | 4 (33.3) | 5 (33.3) |
| Primary site | |||
| Rectum | 3 (100.0) | 7 (58.3) | 10 (66.7) |
| Colon | 0 | 4 (33.3) | 4 (26.7) |
| Colon and rectum | 0 | 1 (8.3) | 1 (6.7) |
| Histological type | |||
| Well differentiated | 2 (66.7) | 4 (33.3) | 6 (40.0) |
| Moderately differentiated | 1 (33.3) | 6 (50.0) | 7 (46.7) |
| Poorly differentiated | 0 | 1 (8.3) | 1 (6.7) |
| Others | 0 | 1 (8.3) | 1 (6.7) |
| Previous chemotherapy | |||
| Oxaliplatin-based regimen | 2 (66.7) | 1 (8.3) | 3 (20.0) |
| Oxaliplatin-based regimen + bevacizumab | 0 | 11 (91.7) | 11 (73.3) |
| Capecitabine monotherapy | 1 (33.3) | 0 | 1 (6.7) |
| UGT1A1 genotype | |||
| Wild (*1/*1) | 1 (33.3) | 7 (58.3) | 8 (66.7) |
| Heterozygous (*1/*28, *1/*6) | 1 (33.3) | 4 (33.3) | 5 (33.3) |
| Homozygous (*28/*28, *6/*6, *28/*6) | 1 (33.3)a | 1 (8.3)b | 2 (13.3) |
Values represent the number (%) of subjects
BID twice daily, ECOG Eastern Cooperative Oncology Group, n number of subjects
aOne subject had UGT1A1 *6/*6 genotype
bOne subject had UGT1A1 *28/*28 genotype