Table 1.
Baseline characteristics: randomized population
| Characteristics | Varlitinib + capecitabine (n = 64) | Placebo + capecitabine (n = 63) |
|---|---|---|
| Median age, years (range) | 63 (31-79) | 64 (36-82) |
| Male, n (%) | 44 (68.8) | 33 (52.4) |
| Race, n (%) | ||
| White | 21 (32.8) | 16 (25.4) |
| Black/African American | 1 (1.6) | 0 (0) |
| Asian | 42 (65.6) | 47 (74.6) |
| Median body mass index, kg/m2 (range) | 24.3 (16-44) | 22.5 (15-38) |
| Geographical location, n (%) | ||
| Asia-Pacific | 46 (71.9) | 48 (76.2) |
| Europe | 11 (17.2) | 9 (14.3) |
| United States | 7 (10.9) | 6 (9.5) |
| Primary tumor location, n (%) | ||
| Intra-hepatic duct | 26 (40.6) | 29 (46.0) |
| Extra-hepatic duct | 8 (12.5) | 12 (19.0) |
| Gallbladder | 18 (28.1) | 16 (25.4) |
| Ampulla of Vater and hilar | 12 (18.8) | 6 (9.5) |
| Recurrent disease, n (%) | 17 (26.6) | 22 (34.9) |
| Extent of disease, n (%) | ||
| Locally advanced | 5 (7.8) | 3 (4.8) |
| Metastatic | 59 (92.2) | 60 (95.2) |
| Baseline ECOG PS, n (%) | ||
| 0 | 37 (57.8) | 26 (41.3) |
| 1 | 27 (42.2) | 37 (58.7) |
| First-line therapy, n (%) | ||
| Gemcitabine + cisplatin | 58 (90.6) | 57 (90.5) |
| Gemcitabine + FOLFOX | 0 (0) | 1 (1.6) |
| Gemcitabine + oxaliplatin | 1 (1.6) | 2 (3.2) |
| Gemcitabine monotherapy | 1 (1.6) | 0 (0) |
| Other | 4 (6.3) | 3 (4.8) |
| Estimated PFS on first-line therapy, months, median (range)a | 6.4 (1-36) | 7.8 (1-55) |
ECOG PS, Eastern Cooperative Oncology Group performance status; PFS, progression-free survival.
a
Estimated from reported start date of first-line treatment and reported date of progression following first-line treatment.