Safety and Pharmacokinetics of Motesanib in Combination with Panitumumab and Gemcitabine-Cisplatin in Patients with Advanced Cancer
Table 2
Patient incidence of motesanib-related adverse events.
Motesanib dose cohort
0 mg QD ()
50 mg QD ()
75 mg QD ()
100 mg QD ()
125 mg QD ()
75 mg BID ()
Patients with any related AE, (%)
0 (0)
6 (75)
6 (100)
4 (67)
11 (100)
2 (100)
Grade 3
0 (0)
2 (25)
2 (33)
1 (17)
6 (55)
1 (50)
Grade 4
0 (0)
0 (0)
2 (33)
2 (33)
3 (27)
1 (50)
Grade 5
0 (0)
1 (13)
0 (0)
0 (0)
1 (9)
0 (0)
Related AEs occurring in ≥10% of all patients, (%)
Hypertension
0 (0)
3 (38)
4 (67)
2 (33)
5 (45)
1 (50)
Nausea
0 (0)
4 (50)
5 (83)
2 (33)
4 (36)
0 (0)
Fatigue
0 (0)
4 (50)
2 (33)
2 (33)
6 (55)
0 (0)
Diarrhea
0 (0)
1 (13)
1 (17)
0 (0)
7 (64)
1 (50)
Anorexia
0 (0)
2 (25)
0 (0)
2 (33)
4 (36)
0 (0)
Pulmonary embolism
0 (0)
1 (13)
2 (33)
2 (33)
3 (27)
0 (0)
Vomiting
0 (0)
2 (25)
3 (50)
1 (17)
2 (18)
0 (0)
Dermatitis acneiform
0 (0)
1 (13)
2 (33)
0 (0)
2 (18)
0 (0)
Rash
0 (0)
0 (0)
1 (17)
0 (0)
2 (18)
2 (100)
Constipation
0 (0)
0 (0)
2 (33)
0 (0)
2 (18)
0 (0)
Deep vein thrombosis
0 (0)
1 (13)
0 (0)
1 (17)
2 (18)
0 (0)
Dehydration
0 (0)
0 (0)
1 (17)
0 (0)
3 (27)
0 (0)
Erythema
0 (0)
1 (13)
2 (33)
1 (17)
0 (0)
0 (0)
Patients with related AEs of specific interest (all grades), (%)
Venous thromboembolic events
0 (0)
2 (25)
3 (50)
2 (33)
3 (27)
0 (0)
Pulmonary embolism
Grade 4
0 (0)
0 (0)
2 (33)
2 (33)
3 (27)
0 (0)
Grade 5
0 (0)
1 (13)
0 (0)
0 (0)
0 (0)
0 (0)
Deep vein thrombosis
Grade 2
0 (0)
1 (13)
0 (0)
0 (0)
0 (0)
0 (0)
Grade 3
0 (0)
0 (0)
0 (0)
1 (17)
2 (18)
0 (0)
Jugular vein thrombosis
Grade 2
0 (0)
0 (0)
1 (17)
0 (0)
0 (0)
0 (0)
Arterial thromboembolic events
0 (0)
1 (13)
0 (0)
0 (0)
1 (9)
1 (50)
Arterial thrombosis
Grade 3
0 (0)
0 (0)
0 (0)
0 (0)
1 (9)
0 (0)
Grade 4
0 (0)
0 (0)
0 (0)
0 (0)
0 (0)
1 (50)
Cerebrovascular accident
Grade 2
0 (0)
1 (13)
0 (0)
0 (0)
0 (0)
0 (0)
Other
Hemorrhagic events
Grade 1
0 (0)
1 (13)
0 (0)
1 (17)
3 (27)
0 (0)
Gallbladder disorder
Grade 1
0 (0)
0 (0)
1 (17)
0 (0)
0 (0)
0 (0)
Neutropenia
Grade 3
0 (0)
1 (13)
0 (0)
0 (0)
0 (0)
0 (0)
AE: adverse event; BID: twice daily; QD: once daily. Sudden death One patient had grade 4 pulmonary embolism and grade 3 deep vein thrombosis. Two patients had grade 4 pulmonary embolism and grade 3 deep vein thrombosis. Includes epistaxis, gingival bleeding, hematemesis, hematochezia, and increased tendency to bruise.
