Table 2 Patient demographics and baseline characteristics—intent-to-treat population

From: Clinical pharmacodynamic/exposure characterisation of the multikinase inhibitor ilorasertib (ABT-348) in a phase 1 dose-escalation trial

Parameter Arm I (ilorasertib PO QD) Arm II (ilorasertib PO BID) Arm III (ilorasertib i.v.) Total
  N = 23 N = 28 N = 7 N = 58
Sex,n (%)
 Female 11 (48) 20 (71) 5 (71) 36 (62)
 Male 12 (52) 8 (29) 2 (29) 22 (38)
Age, years,n (%)
 <65 13 (57) 23 (82) 4 (57) 40 (69)
 ≥65 10 (43) 5 (18) 3 (43) 18 (31)
Age
 Mean (s.d.) 66 (7) 55 (11) 60 (11) 60 (11)
 Median 63 55 60 61
 Range 53–81 35–75 47–75 35–81
Race,n (%)
 White 21 (91) 26 (93) 7 (100) 54 (93)
 Black 2 (9) 2 (7) 0 4 (7)
Ethnicity, n (%)
 Hispanic or Latino 0 3 (11) 2 (29) 5 (9)
 No ethnicity 23 (100) 25 (89) 5 (71) 53 (91)
Tumour type,n (%)
 Lung 1 (4) 0 0 1 (2)
 Prostate 1 (4) 0 0 1 (2)
 Breast 0 2 (7) 0 2 (3)
 Cervical 2 (9) 0 1 (14) 3 (5)
 Pancreatic 1 (4) 5 (18) 0 6 (10)
 Oesophageal 2 (9) 1 (4) 0 3 (5)
 Head and neck 0 1 (4) 1 (14) 2 (3)
 Ovarian 2 (9) 7 (25) 0 9 (16)
 Colorectal 8 (35) 5 (18) 1 (14) 14 (24)
 Other 6 (26) 7 (25) 4 (57) 17 (29)
ECOG PS,n (%)
 0 12 (52) 9 (32) 1 (14) 22 (38)
 1 11 (48) 17 (61) 5 (71) 33 (57)
 2 0 2 (7) 1 (14) 3 (5)
Prior drug regimens,n (%)
 0 0 1 (4) 0 1 (2)
 1 4 (17) 2 (7) 1 (14) 7 (12)
 2 3 (13) 6 (21) 2 (29) 11 (19)
 >2 16 (70) 19 (68) 4 (57) 39 (67)
  1. BID twice daily, ECOG PS Eastern Cooperative Oncology Group performance status, i.v. intravenously, PO orally, QD once daily