Table 1.

Patients' characteristics

Characteristic, n (%)Dose group (neratinib)
40 mg (n = 3)80 mg (n = 4)120 mg (n = 4)180 mg (n = 6)240 mg (n = 3)320 mg (n = 7)*400 mg (n = 6)MTD (n = 39)Total (n = 72)
Sex
    Female2 (67)4 (100)3 (75)6 (100)2 (67)5 (71)4 (67)26 (67)52 (72)
    Male1 (33)01 (25)01 (33)2 (29)2 (33)13 (33)20 (28)
Age, median (range)51 (39-64)52 (48-64)57.5 (34-76)56.5 (46-90)60 (47-64)66 (34-82)49.5 (42-63)57 (34-80)57 (34-90)
ECOG performance status
    002 (50)1 (25)3 (50)2 (67)2 (29)3 (50)18 (47)31 (44)
    13 (100)2 (50)1 (25)3 (50)1 (33)4 (57)2 (33)19 (50)35 (49)
    2002 (50)001 (14)1 (17)1 (3)5 (7)
    Missing000000011
Primary cancer diagnosis
    Breast03 (75)3 (75)6 (100)1 (33)2 (29)3 (50)11 (28)29 (40)
    Non–small cell lung000001 (14)3 (50)11 (28)15 (21)
    Ovarian2 (67)00001 (14)03 (8)6 (8)
    Colorectal1 (33)0000003 (8)4 (6)
    Glioblastoma00000004 (10)4 (6)
    Renal00002 (67)001 (3)3 (4)
    Pancreatic00000002 (5)2 (3)
    Other01 (25)1 (25)003 (43)04 (10)9 (13)
Previous chemotherapy regimens, any setting
    1-20004 (67)1 (33)1 (14)2 (33)12 (31)20 (28)
    301 (25)1 (25)1 (17)01 (14)1 (17)3 (8)8 (11)
    ≥43 (100)3 (75)3 (75)1 (17)2 (67)5 (71)3 (50)24 (62)44 (61)
  • Abbreviations: MTD, maximum tolerated dose; ECOG, Eastern Cooperative Oncology Group.

  • * The 320-mg cohort had seven patients because one patient in the group was not evaluable for safety and efficacy and had to be replaced.

  • One patient's ECOG performance status was missing because one site did not report the data.