Table 1.
Baseline patient demographics and characteristics
| Cohort | Adavosertib dose (schedule) |
n | Mean age, years (SD) |
Female, n (%) |
ECOG performance status, n (%)a |
Number of previous systemic therapy regimens | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 0 | 1 | 0 | 1 | 2 | 3 | ≥ 4 | ||||||
| bid 1 | 125 mg bid (5/9)b | 6 | 56.5 (9.2) | 3 (50.0) | 5 (83.3) | 1 (16.7) | 1 (16.7) | 0 | 1 (16.7) | 0 | 4 (66.7) | |
| bid 2 | 150 mg bid (5/9)b | 6 | 66.5 (10.9) | 4 (66.7) | 2 (33.3) | 4 (66.7) | 1 (16.7) | 1 (16.7) | 1 (16.7) | 1 (16.7) | 2 (33.3) | |
| qd 1.1 | 200 mg qd (5/9)b | 5 | 55.2 (11.3) | 2 (40.0) | 1 (20.0) | 4 (80.0) | 0 | 1 (20.0) | 0 | 1 (20.0) | 3 (60.0) | |
| qd 1.2 | 200 mg qd (5/2)c | 6 | 58.5 (6.0) | 6 (100.0) | 1 (16.7) | 5 (83.3) | 0 | 0 | 1 (16.7) | 1 (16.7) | 4 (66.7) | |
| qd 2.1 | 250 mg qd (5/9)b | 4 | 65.3 (7.6) | 2 (50.0) | 0 | 4 (100.0) | 0 | 0 | 1 (25.0) | 2 (50.0) | 1 (25.0) | |
| qd 2.2 | 250 mg qd (5/2)c | 3 | 62.0 (6.6) | 3 (100.0) | 0 | 3 (100.0) | 0 | 1 (33.3) | 0 | 0 | 2 (66.7) | |
| qd 2.3 | 250 mg qd (5/2 weekly)d | 10 | 62.1 (12.3) | 5 (50.0) | 0 | 10 (100.0) | 1 (10.0) | 1 (10.0) | 1 (10.0) | 0 | 7 (70.0) | |
| qd 3.1 | 300 mg qd (5/9)b | 4 | 51.0 (16.8) | 2 (50.0) | 0 | 4 (100.0) | 0 | 0 | 2 (50.0) | 1 (25.0) | 1 (25.0) | |
| qd 3.2 | 300 mg qd (5/2)c | 16 | 65.3 (13.3) | 12 (75.0) | 5 (31.3) | 11 (68.8) | 0 | 1 (6.3) | 5 (31.3) | 2 (12.5) | 8 (50.0) | |
| qd 3.3 | 300 mg (5/2 weekly)d | 2 | 51.5 (5.0) | 1 (50.0) | 0 | 2 (100.0) | 0 | 0 | 1 (50.0) | 0 | 1 (50.0) | |
| Total | 62 | 61.0 (11.7) | 40 (64.5) | 14 (22.6) | 48 (77.4) | 3 (4.8) | 5 (8.1) | 13 (21.0) | 8 (12.9) | 33 (53.2) | ||
aECOG defines ‘0’ as ‘fully active’ and ‘1’ as ‘restricted in physically strenuous activity’; bCohorts bid 1, bid 2, qd 1.1, 2.1 and 3.1: 5/9 schedule with dosing on days 1–5 in a 14-day cycle; cCohorts qd 1.2, 2.2, and 3.2: 5/2 schedule with dosing on days 1–5 and 8–12 in a 21-day cycle; dCohorts qd 2.3 and 3.3: 5/2 weekly schedule with dosing on days 1–5, 8–12 and 15–19 in a 21-day cycle
bid, twice daily; ECOG, Eastern Cooperative Oncology Group; n, number of patients; qd, once daily; SD, standard deviation