The study involves the use of three different dosing regimens of AMG 706 in patients with advanced solid tumors to see how the drug affects the gallbladder size and function. The study will be conducted in 11 sites in the US and Australia. A total of 48 patients will be enrolled in the study with the possibility of enrolling 8 more in each treatment arm.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
49
Average change from baseline in gallbladder size (volume by ultrasound)
Time frame: Anticipated 8 months of treatment with AMG 706
Average change from baseline in gallbladder function (ejection fraction)
Time frame: Subject treatment with AMG 706 anticipated to be 8 months
Average changes from baseline in gallbladder size (volume by CT scan)
Time frame: Subject treatment with AMG 706 anticipated to be 8 months
Maximum change from baseline in gallbladder size (volume) and function (ejection fraction)
Time frame: Subject treatment with AMG 706 anticipated to be 8 months
Change in gallbladder size (volume) and function (ejection fraction) between the last on-treatment measurement and the last available off-treatment measurement
Time frame: Subject treatment with AMG 706 anticipated to be 8 months
Objective response in subjects with measurable disease at baseline
Time frame: Subject treatment with AMG 706 anticipated to be 8 months
Pharmacokinetics of AMG 706 monotherapy
Time frame: Subject treatment with AMG 706 anticipated to be 8 months
Subject incidence of treatment-emergent adverse events (including all, serious, grade 3, grade 4 and treatment-related
Time frame: Subject treatment with AMG 706 anticipated to be 8 months
Other selected gallbladder characteristics such as size, area, wall thickness, ductal size, presence of stones, pericholecystic fluid and sludge
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Time frame: Subject treatment with AMG 706 anticipated to be 8 months