Table 3.
Treatment-related adverse events (AEs) by preferred term reported in ≥15% of patients by dosing schedule.
| Sapanisertib | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Dose-escalation phase | Expansion phase | ||||||||
| AE, n (%) | QD 2–7 mg (n = 31) |
QD × 5dQW 7–13 mg (n = 22) |
QD × 3dQW 6–20 mg (n = 33) |
QW 7–40 mg (n = 30) |
Total (n = 116) |
QD 5 mg (n = 39) |
QW 30 mg (n = 17) |
QW 40 mg (n = 26) |
Total (n = 82) |
| Hyperglycaemia | 25 (81) | 11 (50) | 22 (67) | 17 (57) | 75 (65) | 17 (44) | 12 (71) | 20 (77) | 49 (60) |
| Nausea | 13 (42) | 13 (59) | 23 (70) | 22 (73) | 71 (61) | 20 (51) | 11 (65) | 20 (77) | 51 (62) |
| Stomatitisa | 11 (35) | 13 (59) | 23 (70) | 9 (30) | 56 (48) | 19 (49) | 8 (47) | 10 (38) | 37 (45) |
| Vomiting | 8 (26) | 10 (45) | 18 (55) | 17 (57) | 53 (46) | 12 (31) | 10 (59) | 19 (73) | 41 (50) |
| Decreased appetite | 11 (35) | 7 (32) | 17 (52) | 8 (27) | 43 (37) | 17 (44) | 6 (35) | 14 (54) | 37 (45) |
| Diarrhoea | 11 (35) | 8 (36) | 13 (39) | 9 (30) | 41 (35) | 17 (44) | 5 (29) | 13 (50) | 35 (43) |
| Asthenia | 6 (19) | 9 (41) | 10 (30) | 12 (40) | 37 (32) | 7 (18) | 1 (6) | 4 (15) | 12 (15) |
| Fatigue | 8 (26) | 7 (32) | 12 (36) | 8 (27) | 35 (30) | 22 (56) | 11 (65) | 23 (88) | 56 (68) |
| Rash | 8 (26) | 3 (14) | 7 (21) | 2 (7) | 20 (17) | 1 (3) | 0 (0) | 1 (4) | 2 (2) |
| Dysgeusia | 8 (26) | 4 (18) | 4 (12) | 3 (10) | 19 (16) | 10 (26) | 3 (18) | 3 (12) | 16 (20) |
| Pruritus generalised | 8 (26) | 1 (5) | 6 (18) | 0 (0) | 15 (13) | 11 (28) | 2 (12) | 2 (8) | 15 (18) |
| Blood creatinine increased | 7 (23) | 0 (0) | 2 (6) | 3 (10) | 12 (10) | 3 (8) | 1 (6) | 4 (15) | 8 (10) |
| Dry mouth | 5 (16) | 2 (9) | 2 (6) | 3 (10) | 12 (10) | 3 (8) | 1 (6) | 6 (23) | 10 (12) |
| Hypercholesterolemia | 5 (16) | 1 (5) | 4 (12) | 1 (3) | 11 (9) | 0 (0) | 1 (6) | 0 (0) | 1 (1) |
| Pruritus | 2 (6) | 3 (14) | 1 (3) | 2 (7) | 8 (7) | 7 (18) | 1 (6) | 3 (12) | 11 (13) |
| Hypophosphatemia | 0 (0) | 2 (9) | 5 (15) | 0 (0) | 7 (6) | 3 (8) | 2 (12) | 4 (15) | 9 (11) |
| Weight decreased | 1 (3) | 2 (9) | 2 (6) | 2 (7) | 7 (6) | 5 (13) | 0 (0) | 4 (15) | 9 (11) |
| Headache | 0 (0) | 1 (5) | 3 (9) | 2 (7) | 6 (5) | 0 (0) | 0 (0) | 4 (15) | 4 (5) |
| Rash maculo-papular | 3 (10) | 2 (9) | 1 (3) | 0 (0) | 6 (5) | 14 (36) | 2 (12) | 1 (4) | 17 (21) |
| Anaemia | 3 (10) | 0 (0) | 1 (3) | 1 (3) | 5 (4) | 2 (5) | 2 (12) | 8 (31) | 12 (15) |
| Dehydration | 3 (10) | 0 (0) | 1 (3) | 1 (3) | 5 (4) | 2 (5) | 2 (12) | 5 (19) | 9 (11) |
| Acute kidney injury | 1 (3) | 0 (0) | 0 (0) | 0 (0) | 1 (1) | 2 (5) | 0 (0) | 4 (15) | 6 (7) |
| Dyspepsia | 1 (3) | 0 (0) | 1 (3) | 1 (3) | 3 (3) | 1 (3) | 3 (18) | 2 (8) | 6 (7) |
QD once daily, QD × 3dQW once daily for 3 days on and 4 days off each week, QD × 5dQW once daily for 5 days on and 2 days off each week, QW once weekly.
aIncludes oropharyngeal pain and mucosal inflammation.