Table 1.
Patient demographics and baseline clinical characteristics
| Phase 1 |
Phase 2A | MTDa | Overall | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Weekly |
Bi-Weekly |
|||||||||
| Characteristic | Statistic | 6 mg/m2 (n=6) |
12 mg/m2 (n=3) |
18 mg/m2 (n=3) |
12 mg/m2 (n=3) |
15 mg/m2 (n=6) |
18 mg/m2 (n=3) |
15 mg/m2 (n=38) |
15 mg/m2 (n=44) |
(n=62) |
| Age | Mean | 54.8 | 58.7 | 64.3 | 60.3 | 65.5 | 56.7 | 62.8 | 63.2 | 61.8 |
| SD | 7.8 | 4.5 | 11.6 | 7.4 | 11.0 | 8.7 | 9.1 | 9.3 | 9.1 | |
| Median | 52.0 | 59.0 | 70.0 | 63.0 | 63.0 | 59.0 | 65.0 | 65.0 | 63.0 | |
| Range | 46–65 | 54–63 | 51–72 | 52–66 | 54–79 | 47–64 | 39–76 | 39–79 | 39–79 | |
| BSA (m2) | Mean | 1.8 | 2.2 | 1.7 | 1.9 | 1.9 | 2.0 | 1.8 | 1.8 | 1.8 |
| Gender | ||||||||||
| Male | n (%) | 3 (50.0) | 3 (100.0) | 1 (33.3) | 2 (66.7) | 2 (33.3) | 2 (66.7) | 18 (47.4) | 20 (45.5) | 31 (50.0) |
| Female | n (%) | 3 (50.0) | 0 | 2 (66.7) | 1 (33.3) | 4 (66.7) | 1 (33.3) | 20 (52.6) | 24 (54.5) | 31 (50.0) |
| Race | ||||||||||
| White | n (%) | 5 (83.3) | 3 (100.0) | 1 (33.3) | 0 | 5 (83.3) | 2 (66.7) | 29 (76.3) | 34 (77.3) | 45 (72.6) |
| Asian | n (%) | 1 (16.7) | 0 | 1 (33.3) | 2 (66.7) | 1 (16.7) | 1 (33.3) | 5 (13.2) | 6 (13.6) | 11 (17.7) |
| American Indian or Alaska Native | n (%) | 0 | 0 | 0 | 0 | 0 | 0 | 3 (7.9) | 3 (6.8) | 3 (4.8) |
| Other | n (%) | 0 | 0 | 1 (33.3) | 1 (33.3) | 0 | 0 | 1 (2.6) | 1 (2.3) | 3 (4.8) |
| ECOG | ||||||||||
| 0 | n (%) | 3 (50.0) | 1 (33.3) | 0 | 2 (66.7) | 4 (66.7) | 1 (33.3) | 16 (42.1) | 20 (45.5) | 27 (43.5) |
| 1 | n (%) | 3 (50.0) | 2 (66.7) | 3 (100.0) | 1 (33.3) | 1 (16.7) | 2 (66.7) | 21 (55.3) | 22 (50.0) | 33 (53.2) |
| 2 | n (%) | 0 | 0 | 0 | 0 | 1 (16.7) | 0 | 1 (2.6) | 2 (4.5) | 2 (3.2) |
| Cancer Type | ||||||||||
| Lung | n (%) | 6 (25.0) | 21 (55.3) | 22 (50.0) | 27 (43.5) | |||||
| Pancreas | n (%) | 5 (20.8) | 6 (15.8) | 4 (15.9) | 11 (17.7) | |||||
| Head and Neck | n (%) | 1 (4.2) | 2 (5.3) | 2 (4.6) | 3 (4.8) | |||||
| Renal | n (%) | 2 (8.3) | 2 (5.3) | 3 (6.8) | 4 (6.5) | |||||
| Ovarian | n (%) | 1 (4.2) | 2 (5.3) | 2 (4.6) | 3 (4.8) | |||||
| Breast | n (%) | 3 (12.5) | 0 | 2 (4.6) | 3 (4.8) | |||||
| Bile Duct | n (%) | 1 (4.2) | 1 (2.6) | 1 (2.3) | 2 (3.2) | |||||
| Uterine | n (%) | 1 (4.2) | 1 (2.6) | 2 (4.6) | 2 (3.2) | |||||
| Otherb | n (%) | 4 (16.7) | 3 (7.9) | 3 (6.8) | 7 (11.3) | |||||
| Prior Therapies | Median (Mean) | 3 (3.6) | 4 (3.5) | 4 (3.6) | 3 (3.5) | |||||
a
Includes all patients in Phase 1 and 2a treated at the MTD dose
b
Other cancers include: ampullary, colon, intestinal, gastric, liver, thyroid, urethral (n=l for each)