Table 2.
Demographics and baseline characteristics of participants in the population pharmacokinetic (PK) analysis dataset
| Covariates | n = 442 |
|---|---|
| Continuous covariates, median (range) | |
| Age (years) | 52 (18–83) |
| Body weight (kg) | 73 (41–172) |
| Height (cm) | 167.6 (137.2–196.0) |
| BMI (kg/m2) | 25.3 (15.6–50.3) |
| ALT (U/L) | 25 (5–129) |
| AST (U/L) | 25 (10–99) |
| Total bilirubin (µmol/L) | 9 (1–74) |
| Albumin (g/dL) | 38 (20–56) |
| CrCL (mL/min) | 98.8 (32.7–235.6) |
| eGFR (mL/min/1.73 m2) | 85.6 (32.7–277.5) |
| Categorical covariates, n (%) | |
| Sex | |
| Male | 227 (51.4) |
| Female | 215 (48.6) |
| Race | |
| White | 304 (68.8) |
| Asian | 103 (23.3) |
| Black | 26 (5.9) |
| Other | 9 (2.0) |
| ECOG status | |
| 0 | 105 (23.8) |
| 1 | 110 (24.9) |
| 2 | 213 (48.2) |
| 3 | 14 (3.2) |
| Patients with cancer | 337 (76.2)a |
| Healthy volunteers | 105 (23.8) |
ALK anaplastic lymphoma kinase, ALT alanine aminotransferase, AST aspartate aminotransferase, BMI body mass index, CrCL creatinine clearance, ECOG Eastern Cooperative Oncology Group, eGFR estimated glomerular filtration rate, NSCLC non-small cell lung cancer
aPK data in patients with cancer were obtained from 136 of 137 patients in the phase I/II study and 202 of 222 patients in the phase II ALTA study. The phase I/II study included 128 patients with NSCLC (79 were ALK +) and 9 patients with other malignancies, which included one patient with adenocarcinoma of unknown origin (ALK +), one cancer of unknown primary origin (ALK-rearranged), one cholangiocarcinoma, one colon cancer, two inflammatory myofibroblastic tumors (ALK +), one neuroendocrine carcinoma (ALK +), one pancreatic adenocarcinoma, and one small-cell lung carcinoma [3]. All patients in the phase II study had ALK + NSCLC [4]