Safety and pharmacokinetics of motesanib in combination with gemcitabine and erlotinib for the treatment of solid tumors: a phase 1b study

Table 2 Patient incidence of motesanib-related adverse events

	Motesanib + Gemcitabine + Erlotinib (100 mg QD)				Motesanib + Erlotinib (150 mg QD)
Patient Incidence	Motesanib 50 mg QD (n = 7)	Motesanib 100 mg QD (n = 8)	Motesanib 125 mg QD (n = 10)	Motesanib 75 mg BID (n = 9)	Motesanib 100 mg QD (n = 7)	Motesanib 125 mg QD (n = 7)
Any adverse event, n	3	8	9	7	7	6
Adverse events of grade 3, n^a	0	3	6	3	3	4
Diarrhea	0	1	1	0	2	1
Nausea	0	0	3	1	0	0
Vomiting	0	1	2	0	0	0
Fatigue	0	1	0	0	0	2
Tumor necrosis	0	0	0	1	1	0
Deep vein
thrombosis	0	0	2	0	0	0
Abnormal liver
function test	0	1	0	0	0	1
Neutropenia	0	1	0	0	1	0
Adverse events of grade 4, n
Pulmonary	1	0	2	1	0	0
embolism	0	0	2	0	0	0
Febrile neutropenia	1	0	0	0	0	0
Neutropenia	0	0	0	1	0	0
Adverse events of interest and highest (worst) grade, n
Hypertension	0	0	0	2	1	2
Grade 3	0	0	0	0	0	1
Thrombophlebitis (all grade 3)	0	0	1	0	0	0
Gallbladder toxicity	0	0	2^b	0	1^c	0
Grade 3	0	0	1	0	0	0
Hemorrhagic events	0	0	1^d	0	1^e	0
Grade 3	0	0	1	0	0	0
Cardiac toxicity (all grade 3)	0	1^f	0	0	0	0

BID = twice daily; QD = once daily
^aFor motesanib-related adverse events only those grade 3 events are listed that occurred in ≥ 2 patients.
^bCholecystitis (n = 1; grade 3) and gallbladder enlargement (n = 1; grade 1)
^cGallbladder enlargement (grade 2)
^dSubdural hematoma
^eEpistaxis (grade 1)
^fCongestive heart failure and pulmonary edema

ISSN: 1471-2407