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Table 4 Treatment-related adverse events occurring in ≥20% of patients in any treatment arm with QOD and Q3W dosing schedules of MK-2206

From: Phase 1 trial of the oral AKT inhibitor MK-2206 plus carboplatin/paclitaxel, docetaxel, or erlotinib in patients with advanced solid tumors

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
  1. aMK-2206 QOD explored with docetaxel 75 mg/m2 only.
  2. bMK-2206 Q3W explored with docetaxel 60 mg/m2 only.
  3. c100 mg erlotinib.
  4. d150 mg erlotinib.
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Journal of Hematology & Oncology

ISSN: 1756-8722

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