Part 1: pictilisib + paclitaxel ± bevacizumaba | Part 2A: pictilisib + paclitaxel | Part 2B: pictilisib + paclitaxel + bevacizumab | Part 2C: pictilisib + paclitaxel + trastuzumab | Part 3: pictilisib + letrozole | All patients (N = 69) | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Pictilisib dose n (%) | 60 mg (n = 13) | 100 mg (n = 7) | 165 mg (n = 3) | 250 mg (n = 9) | 330 mg (n = 6) | 200 mg (n = 6) | 250 mg (n = 6) | 260 mg (n = 3) | 180 mg (n = 3) | 260 mg (n = 6) | 260 mg (n = 7) | |
All-grade AEs | 13 (100) | 7 (100) | 3 (100) | 9 (100) | 6 (100) | 6 (100) | 6 (100) | 3 (100) | 3 (100) | 6 (100) | 7 (100) | 69 (100) |
Grades 3–4 AEs | 8 (61.5) | 7 (100) | 3 (100) | 7 (77.8) | 5 (83.3) | 3 (50.0) | 5 (83.3) | 3 (100) | 1 (33.3) | 3 (50.0) | 3 (42.9) | 48 (69.6) |
Grade 5 AEs | 1 (7.7)b | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (14.3)c | 2 (2.9) |
SAEs | 3 (23.1) | 1 (14.3) | 1 (33.3) | 5 (55.6) | 5 (83.3) | 2 (33.3) | 0 | 0 | 0 | 1 (16.7) | 3 (42.9) | 21 (30.4) |
DLTs | 1 (7.7) | 0 | 0 | 1 (11.1) | 2 (33.3) | 0 | 1 (16.7) | 0 | 0 | 1 (16.7) | 0 | 6 (8.7) |
Study withdrawal due to AE | 3 (23.1) | 2 (28.6) | 0 | 1 (11.1) | 2 (33.3) | 0 | 1 (16.7) | 2 (66.7) | 0 | 2 (33.3) | 2 (28.6) | 15 (21.7) |
Pictilisib withdrawal due to AE | 4 (30.8) | 2 (28.6) | 1 (33.3) | 1 (11.1) | 2 (33.3) | 0 | 1 (16.7) | 3 (100) | 0 | 2 (33.3) | 2 (28.6) | 18 (26.1) |
n = 62 | ||||||||||||
Paclitaxel withdrawal due to AE | 6 (46.2) | 3 (42.9) | 2 (66.7) | 1 (11.1) | 2 (33.3) | 0 | 1 (16.7) | 2 (66.7) | 1 (33.3) | 3 (50.0) | – | 21 (33.9) |
n = 35 | ||||||||||||
Bevacizumab withdrawal due to AE | 6 (46.2) | 3 (42.9) | – | – | – | 2 (33.3) | 1 (16.7) | 2 (66.7) | – | – | – | 14 (40.0) |
(n = 9) | ||||||||||||
Trastuzumab withdrawal due to AE | – | – | – | – | – | – | – | – | 0 | 0 2 (33.3) | – | 2 (22.2) |
Letrozole withdrawal due to AE | – | – | – | – | – | – | – | – | – | – | 2 (28.6) | – |
Pictilisib dose reduction due to AE | 0 | 0 | 0 | 1 (11.1) | 1 (16.7) | 0 | 3 (50.0) | 1 (33.3) | 0 | 0 | 0 | 6 (8.7) |
Pictilisib dose interruption due to AE | 7 (53.8) | 3 (42.9) | 2 (66.7) | 5 (55.6) | 4 (66.7) | 4 (66.7) | 3 (50.0) | 3 (100) | 0 | 4 (66.7) | 4 (57.4) | 39 (56.5) |