Table 1.
Patient demographics and baseline disease characteristics
| Parameter/statistics | Dose-escalation cohort | Dose-expansion cohort (ALK-positive) | Both cohorts |
|---|---|---|---|
| Total (n = 30)a | 525 mg (n = 16)b | All patients (n = 46) | |
| Sex, n (%) | |||
| Male | 14 (47) | 8 (50) | 22 (48) |
| Female | 16 (53) | 8 (50) | 24 (52) |
| Race, n (%) | |||
| White | 25 (83) | 1 (6) | 26 (57) |
| Black or African American | 5 (17) | 14 (88) | 19 (41) |
| Asian | 0 | 1 (6) | 1 (2) |
| Age (years) | |||
| Mean (standard deviation) | 61.6 (9.6) | 51.1 (11.8) | 57.9 (11.5) |
| Median (range) | 64 (44–77) | 51 (19–71) | 61 (19–77) |
| Weight (kg), mean (standard deviation) | 80.3 (20.4) | 75.0 (11.6) | 78.5 (17.9) |
| ECOG performance status, n (%) | |||
| Grade 0 | 6 (20) | 9 (56) | 15 (33) |
| Grade 1 | 19 (63) | 7 (44) | 26 (57) |
| Grade 2 | 5 (17) | 0 | 5 (11) |
| Primary tumor type, n (%) | |||
| Lung adenocarcinoma | 4 (13) | 7 (44) | 11 (24) |
| NSCLC | 0 | 6 (38) | 6 (13) |
| Malignant lung neoplasm | 0 | 2 (13) | 2 (4) |
| Breast | 4 (13) | 0 | 4 (9) |
| Adenocarcinoma (unspecified primary) | 3 (10) | 0 | 3 (7) |
| Leiomyosarcoma | 3 (10) | 0 | 3 (7) |
| Colon | 2 (7) | 0 | 2 (4) |
| Bile duct | 2 (7) | 0 | 2 (4) |
| Ovarian | 2 (7) | 0 | 2 (4) |
| Other | 10 (33) | 1 (6) | 11 (24) |
| Brain metastases history, n (%) | – | 9 (56) | – |
| Prior radiation therapy, n (%) | 18 (60) | 14 (88) | 32 (70) |
ALK anaplastic lymphoma kinase, ECOG Eastern Cooperative Oncology Group, NSCLC non-small cell lung carcinoma, UNK unknown
aExcludes 3 ALK-positive patients
bIncludes 3 ALK-positive patients from the dose-escalation cohort