Table 1.

Baseline demographic and patient characteristics

S1 (n = 44)S2 (n = 24)S3 (n = 12)NSCLC expansion (n = 15)Total (n = 95)
Age, median (range)63 (34–83)60 (20–72)49 (28–85)62 (45–71)62 (20–85)
Age group, n (%)
18–394 (9)2 (8)2 (17)0 (0)8 (8)
40–6423 (52)13 (54)7 (58)10 (67)53 (56)
≥6517 (39)9 (38)3 (25)5 (33)34 (36)
Sex, n (%)
Female21 (48)12 (50)6 (50)9 (60)48 (51)
Male23 (52)12 (50)6 (50)6 (40)47 (49)
Race, n (%)
White38 (86)20 (83)12 (100)14 (93)84 (88)
Hispanic1 (2)0 (0)0 (0)0 (0)1 (1)
Black5 (11)4 (17)0 (0)1 (7)10 (11)
ECOG PS, n (%)
013 (30)12 (50)8 (67)3 (20)36 (38)
130 (68)12 (50)3 (25)12 (80)57 (60)
21 (2)01 (8)02 (2)
Cotinine test, n (%)
Negative43 (98)24 (100)11 (92)14 (93)92 (97)
Positive0001 (7)1 (1)
Not done1 (2)01 (8)02 (2)
Tumor type, n (%)
NSCLC8 (18)6 (25)3 (25)15 (100)32 (34)
Pancreatic4 (9)0004 (4)
Colorectal4 (9)0004 (4)
Prostate3 (7)2 (8)005 (5)
Other25 (57)16 (67)9 (75)050 (53)
Prior chemotherapy regimens, n (%)
0–221 (48)11 (46)6 (50)8 (53)46 (48)
3–518 (41)11 (46)6 (50)7 (47)42 (44)
6–85 (11)2 (8)007 (7)
Prior radiotherapy, n (%)29 (66)13 (54)7 (58)12 (80)61 (64)
Prior disease-related surgery, n (%)33 (75)16 (67)11 (92)6 (40)66 (69)
Prior hormonal therapy and immunotherapy, n (%)10 (23)3 (12)0013 (14)
  • NOTE: Patient characteristics are shown for each cohort: S1, intermittent linsitinib once daily (days 1–3 every 7 days); S2, continuous linsitinib once daily; S3, continuous linsitinib twice daily, each with erlotinib 100 or 150 mg once daily, and NSCLC expansion cohort treated at 150 mg twice daily linsitinib, 150 mg once daily erlotinib.