Adverse event, n (%) | Arm 1: carboplatin AUC 6; | Arm 2: docetaxel | Arm 3: erlotinib | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Paclitaxel 200 mg/m2 | 75 mg/m2 | 60 mg/m2 | 100 mg and 150 mg | ||||||||||
MK-2206 | MK-2206 | MK-2206 | MK-2206 | MK-2206 | MK-2206 | ||||||||
QOD | Q3W | QODa | Q3Wb | QOD | QW | ||||||||
45 mg (n = 6) | 60 mg (n = 9) | 90 mg (n = 5) | 135 mg (n = 5) | 200 mg (n = 6) | 45 mg (n = 5) | 90 mg (n = 3) | 135 mg (n = 4) | 200 mg (n = 4) | 45 mgc(n = 9) | 45 mgd(n = 4) | 135 mgc(n = 6) | 135 mgd(n = 6) | |
Fatigue | |||||||||||||
Grade 1/2 | 5 (83) | 6 (66) | 4 (80) | 4 (80) | 1 (17) | 4 (80) | 3 (100) | 2 (50) | 4 (100) | 4 (44) | 3 (75) | 4 (66) | 3 (50) |
Grade 3 | 0 | 0 | 0 | 1 (20) | 0 | 0 | 0 | 0 | 0 | 1 (11) | 0 | 0 | 1 (17) |
Grade 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Nausea | |||||||||||||
Grade 1/2 | 3 (50) | 5 (55) | 3 (60) | 2 (40) | 4 (66) | 2 (40) | 1 (33) | 1 (25) | 2 (50) | 2 (22) | 4 (100) | 1 (17) | 2 (33) |
Grade 3 | 0 | 1 (11) | 1 (20) | 0 | 0 | 0 | 0 | 0 | 0 | 1 (11) | 0 | 0 | 0 |
Grade 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Rash | |||||||||||||
Grade 1/2 | 3 (50) | 1 (11) | 0 | 1 (20) | 1 (17) | 4 (80) | 2 (66) | 0 | 1 (25) | 3 (33) | 1 (25) | 4 (66) | 5 (83) |
Grade 3 | 1 (17) | 1 (11) | 1 (20) | 0 | 1 (17) | 0 | 0 | 0 | 0 | 2 (22) | 2 (50) | 0 | 0 |
Grade 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Decreased appetite | |||||||||||||
Grade 1/2 | 2 (33) | 5 (55) | 2 (40) | 2 (40) | 2 (33) | 2 (40) | 0 | 2 (50) | 1 (25) | 1 (11) | 4 (100) | 3 (50) | 5 (83) |
Grade 3 | 0 | 0 | 0 | 1 (20) | 0 | 0 | 0 | 0 | 0 | 1 (11) | 0 | 0 | 0 |
Grade 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Diarrhea | |||||||||||||
Grade 1/2 | 1 (17) | 4 (44) | 2 (40) | 1 (20) | 2 (33) | 1 (20) | 2 (66) | 0 | 2 (50) | 4 (44) | 3 (75) | 4 (66) | 5 (83) |
Grade 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (11) | 0 | 0 | 0 |
Grade 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Alopecia | |||||||||||||
Grade 1/2 | 4 (66) | 6 (66) | 5 (100) | 4 (80) | 2 (33) | 3 (60) | 1 (33) | 1 (25) | 2 (50) | 0 | 0 | 1 (17) | 0 |
Grade 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (17) | 0 |
Grade 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Vomiting | |||||||||||||
Grade 1/2 | 1 (17) | 3 (33) | 0 | 3 (60) | 4 (66) | 3 (60) | 1 (33) | 1 (25) | 1 (25) | 4 (44) | 1 (25) | 1 (17) | 0 |
Grade 3 | 0 | 1 (11) | 1 (20) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (17) | 0 |
Grade 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Anemia | |||||||||||||
Grade 1/2 | 1 (17) | 1 (11) | 2 (40) | 1 (20) | 1 (17) | 2 (40) | 0 | 1 (25) | 1 (25) | 2 (22) | 0 | 0 | 2 (33) |
Grade 3 | 0 | 3 (33) | 1 (20) | 1 (20) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (17) | 0 |
Grade 4 | 1 (17) | 1 (11) | 0 | 1 (20) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (17) |
Stomatitis | |||||||||||||
Grade 1/2 | 1 (17) | 2 (22) | 2 (40) | 1 (20) | 1 (17) | 2 (40) | 0 | 1 (25) | 0 | 3 (33) | 1 (25) | 4 (66) | 4 (66) |
Grade 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (11) | 0 | 0 | 0 |
Grade 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Neutropenia | |||||||||||||
Grade 1/2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Grade 3 | 0 | 2 (22) | 2 (40) | 1 (20) | 1 (17) | 1 (20) | 1 (33) | 0 | 0 | 0 | 0 | 0 | 0 |
Grade 4 | 1 (17) | 3 (33) | 2 (40) | 2 (40) | 0 | 2 (40) | 1 (33) | 0 | 1 (25) | 0 | 0 | 0 | 0 |
Leukopenia | |||||||||||||
Grade 1/2 | 1 (17) | 3 (33) | 0 | 1 (20) | 0 | 0 | 1 (33) | 0 | 1 (25) | 0 | 0 | 0 | 0 |
Grade 3 | 0 | 1 (11) | 4 (80) | 2 (40) | 1 (17) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Grade 4 | 0 | 2 (22) | 0 | 1 (20) | 0 | 1 (20) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Thrombocytopen-ia | |||||||||||||
Grade 1/2 | 0 | 4 (44) | 1 (20) | 1 (20) | 1 (17) | 2 (40) | 1 (33) | 0 | 0 | 0 | 0 | 0 | 1 (17) |
Grade 3 | 1 (17) | 1 (11) | 1 (20) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Grade 4 | 0 | 0 | 0 | 2 (40) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Pruritus | |||||||||||||
Grade 1/2 | 4 (66) | 0 | 0 | 1 (20) | 1 (17) | 2 (40) | 0 | 0 | 0 | 3 (33) | 0 | 2 (33) | 2 (33) |
Grade 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (17) | 0 |
Grade 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |