Skip to main content

Table 1 Patient demographics and baseline disease characteristics

From: First-in-human, open-label dose-escalation and dose-expansion study of the safety, pharmacokinetics, and antitumor effects of an oral ALK inhibitor ASP3026 in patients with advanced solid tumors

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)
  1. ALK anaplastic lymphoma kinase, ECOG Eastern Cooperative Oncology Group, NSCLC non-small cell lung carcinoma, UNK unknown
  2. aExcludes 3 ALK-positive patients
  3. bIncludes 3 ALK-positive patients from the dose-escalation cohort