TABLE 1.
Summary of baseline patient characteristics
| Normal hepatic function (n = 13) | Mild hepatic impairment (n = 10) | Moderate hepatic impairment (n = 8) | |
|---|---|---|---|
| Median age (range), y | 59 (43–66) | 58 (41–70) | 67 (52–78) |
| Sex, n (%) | |||
| Male | 5 (38.5) | 6 (60) | 6 (75) |
| Female | 8 (61.5) | 4 (40) | 2 (25) |
| Race, n (%) | |||
| Caucasian | 13 (100) | 10 (100) | 7 (87.5) |
| Asian | 0 | 0 | 1 (12.5) |
| ECOG performance status, n (%) a | |||
| 0 | 8 (61.5) | 5 (50) | 1 (12.5) |
| 1 | 5 (38.5) | 5 (50) | 6 (75) |
| 2 | 0 | 0 | 1 (12.5) |
| Primary tumour location, n (%) | |||
| Breast | 3 (23.1) | 0 | 0 |
| Head and neck b | 1 (7.7) | 0 | 0 |
| Liver | 0 | 2 (20) | 6 (75) |
| Prostate | 1 (7.7) | 1 (10) | 0 |
| Renal | 0 | 1 (10) | 0 |
| Pancreas | 1 (7.7) | 0 | 0 |
| Ovary | 3 (23.1) | 1 (10) | 0 |
| Colon | 1 (7.7) | 2 (20) | 1 (12.5) |
| Biliary tract | 1 (7.7) | 0 | 1 (12.5) |
| Primary peritoneal | 1 (7.7) | 0 | 0 |
| Other c | 1 (7.7) | 3 (30) | 0 |
| Overall disease classification, n (%) a | |||
| Metastatic | 10 (76.9) | 9 (90) | 3 (37.5) |
| Locally advanced | 2 (15.4) | 0 | 3 (37.5) |
| Both | 1 (7.7) | 1 (10) | 2 (25) |
| Median ALT, μkat L −1 (range) a | 0.5 (0.2–1.9) | 1.3 (0.1–4.4) | 0.7 (0.3–2.3) |
| Median AST, μkat L −1 (range) a | 0.5 (0.2–1.1) | 1.0 (0.4–2.3) | 1.0 (0.6–3.2) |
| Median GGT, μkat L −1 (range) a | 2.1 (0.2–12.6) | 5.2 (0.3–30.8) | 7.3 (1.0–19.4) |
| Median bilirubin, μmol L −1 (range) a | 6.0 (4–19) | 12.8 (3–15) | 24.5 (10–45) |
| Median albumin, g L −1 (range) a | 41.0 (34–46) | 39.0 (30–46) | 27.0 (2–37) |
a
At baseline for Part A.
b
Including nasopharynx, larynx and trachea.
c
Other included cholangiocarcinoma, duodenum, colorectal and unknown (all n = 1).
ALT, alanine aminotransferase; AST, aspartate aminotransferase; ECOG, Eastern Cooperative Oncology Group; GGT, γ‐glutamyl transferase.