Table 1.
Baseline demographics and disease characteristics
| Combined t.i.w. cohorts (n = 42) | Combined q.d. cohorts (n = 44) | Overall population (N = 86) | |
|---|---|---|---|
| Age, y | |||
| Mean (SD) | 58.6 (12.6) | 54.3 (14.1) | 56.4 (13.5) |
| Sex, n (%) | |||
| Male | 19 (45) | 15 (34) | 34 (40) |
| Female | 23 (55) | 29 (66) | 52 (60) |
| Race, n (%) | |||
| White | 31 (74) | 28 (64) | 59 (69) |
| Black | 1 (2) | 1 (2) | 2 (2) |
| Asian | 0 (0) | 3 (7) | 3 (3) |
| Other | 1 (2) | 1 (2) | 2 (2) |
| Missing/unknown | 9 (21) | 11 (25) | 20 (23) |
| ECOG PS, n (%) | |||
| 0 | 10 (24) | 16 (36) | 26 (30) |
| ≥1 | 32 (76) | 28 (64) | 60 (70) |
| Cancer type, n (%) | |||
| Cholangiocarcinoma | 7 (17) | 17 (39) | 24 (28) |
| Intrahepatic | 6 (14) | 16 (36) | 22 (26) |
| Extrahepatic | 1 (2) | 1 (2) | 2 (2) |
| Breast | 7 (17) | 5 (11) | 12 (14) |
| Colorectal | 7 (17) | 5 (11) | 12 (14) |
| Brain | 3 (7) | 4 (9) | 7 (8) |
| Urothelial | 2 (5) | 2 (5) | 4 (5) |
| Other solid tumorsa | 16 (38) | 11 (25) | 27 (31) |
| Head and neck | 3 (7) | 0 (0) | 3 (3) |
| Esophageal | 2 (5) | 1 (2) | 3 (3) |
| Cervical | 0 (0) | 2 (5) | 2 (2) |
| Gastric | 1 (2) | 1 (2) | 2 (2) |
| NSCLC | 2 (5) | 0 (0) | 2 (2) |
| Sarcoma | 1 (2) | 1 (2) | 2 (2) |
| Skin | 1 (2) | 1 (2) | 2 (2) |
| Number of prior regimens, n (%)b | |||
| 1 | 5 (12) | 13 (30) | 18 (21) |
| 2 | 8 (19) | 9 (20) | 17 (20) |
| 3 | 11 (26) | 5 (11) | 16 (19) |
| ≥4 | 17 (40) | 17 (39) | 34 (40) |
ECOG PS, Eastern Cooperative Oncology Group performance status; NSCLC, non–small cell lung cancer; q.d., once daily; SD, standard deviation; t.i.w., 3 times a week.
a
In the overall population, there was one patient each with appendix cancer, endometrial cancer, gallbladder cancer, mesothelioma, neuroendocrine tumor, neuroblastoma, ovarian cancer, prostate cancer, and renal cell carcinoma; there were two patients with adenocarcinoma of unknown primary site.
b
One patient in the combined t.i.w. cohorts did not receive prior anticancer therapy.