Table 2.
Patient demographics and baseline characteristics—intent-to-treat population
| 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) |
BID twice daily, ECOG PS Eastern Cooperative Oncology Group performance status, i.v. intravenously, PO orally, QD once daily