Table 1.
Baseline patient demographics in the BAY 1125976 phase 1 study. BID: twice daily, ECOG: Eastern Cooperative Oncology Group, LSF: liquid service formulation, QD: continuous once daily, WT: wild-type.
| Parameter | 10 mg LSF QD | 20 mg LSF QD | 40 mg Tablet QD | 80 mg Tablet QD | 120 mg Tablet QD | 40 mg Tablet BID | 60 mg Tablet BID | 80 mg Tablet BID | 60 mg Expansion | Total | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Tablet (BID) | |||||||||||
| WT | AKT1E17K | ||||||||||
| N | 3 | 3 | 4 | 13 | 6 | 3 | 15 | 4 | 19 | 9 | 79 |
| Mean age, years (range) | 53.3 (44–67) | 49.7 (37–64) | 59.0 (47–75) | 61.2 (48–75) | 53.5 (37–69) | 66.3 (50–82) | 55.1 (40–74) | 56.3 (38–70) | 55.3 (31–76) | 57.3 (41–73) | 56.7 (31–82) |
| Females, n (%) | 2 (66.7) | 2 (66.7) | 2 (50.0) | 10 (76.9) | 4 (66.7) | 2 (66.7) | 8 (53.3) | 3 (75.0) | 19 (100.0) | 9 (100.0) | 61 (77.2) |
| ECOG performance status, n (%) | |||||||||||
| 0 | 0 | 1 (33.3) | 2 (50.0) | 7 (53.8) | 2 (33.3) | 2 (66.7) | 10 (66.7) | 2 (50.0) | 14 (73.7) | 7 (77.8) | 47 (59.5) |
| 1 | 3 (100.0) | 2 (66.7) | 2 (50.0) | 5 (38.5) | 4 (66.7) | 1 (33.3) | 5 (33.3) | 1 (25.0) | 5 (26.3) | 2 (22.2) | 30 (38.0) |
| 2 | 0 | 0 | 0 | 1 (7.7) | 0 | 0 | 0 | 1 (25.0) | 0 | 0 | 2 (2.5) |
| Prior systemic anticancer therapy, n (%) | 3 (100.0) | 3 (100.0) | 4 (100.0) | 13 (100.0) | 6 (100.0) | 2 (66.7) | 15 (100.0) | 4 (100.0) | 19 (100.0) | 9 (100.0) | 78 (98.7) |
| Prior radiotherapy, n (%) | 3 (100.0) | 3 (100.0) | 2 (50.0) | 8 (61.5) | 5 (83.3) | 2 (66.7) | 12 (80.0) | 1 (25.0) | 18 (94.7) | 6 (66.7) | 60 (75.9) |
Patients with AKT1E17K mutation are also part of the 60 mg BID expansion cohort.