Study Complete
Sponsor ID
20060443

Effect of Different Doses of AMG 706 on the Gallbladder in Advanced Solid Tumors

Sponsor ID
20060443
Clinicaltrials.gov ID
NCT00448786
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

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.

Additional Study Details

Phase
Phase 1
Product
motesanib diphosphate
Type
Interventional
Masking
None (Open Label)
Enrollment
49
Additional Study Details

Protocol Summary

Primary Outcome Measures

Average change from baseline in gallbladder size (volume by ultrasound)

Timeframe: Anticipated 8 months of treatment with AMG 706

Average change from baseline in gallbladder function (ejection fraction)

Timeframe: Subject treatment with AMG 706 anticipated to be 8 months

Secondary Outcome Measures

Average changes from baseline in gallbladder size (volume by CT scan)

Timeframe: Subject treatment with AMG 706 anticipated to be 8 months

Maximum change from baseline in gallbladder size (volume) and function (ejection fraction)

Timeframe: 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

Timeframe: Subject treatment with AMG 706 anticipated to be 8 months

Objective response in subjects with measurable disease at baseline

Timeframe: Subject treatment with AMG 706 anticipated to be 8 months

Pharmacokinetics of AMG 706 monotherapy

Timeframe: 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

Timeframe: 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

Timeframe: Subject treatment with AMG 706 anticipated to be 8 months

Study Documents

Study Synopsis
Available Language(s): English

Locations

No locations found.