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

Molife, L Rhoda; Yan, Li; Vitfell-Rasmussen, Joanna; Zernhelt, Adriane M; Sullivan, Daniel M; Cassier, Philippe A; Chen, Eric; Biondo, Andrea; Tetteh, Ernestina; Siu, Lillian L; Patnaik, Amita; Papadopoulos, Kyriakos P; de Bono, Johann S; Tolcher, Anthony W; Minton, Susan

doi:10.1186/1756-8722-7-1

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			QOD^a	Q3W^b			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 mg^c(n = 9)	45 mg^d(n = 4)	135 mg^c(n = 6)	135 mg^d(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

^aMK-2206 QOD explored with docetaxel 75 mg/m² only.
^bMK-2206 Q3W explored with docetaxel 60 mg/m² only.
^c100 mg erlotinib.
^d150 mg erlotinib.

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