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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm C | Other | Arm C - AMG 706 75 mg BID 5-days on and 2-days off |
|
| Arm B | Other | Arm B - AMG 706 75 mg BID 2-weeks on and 1-week off |
|
| Arm A | Other | Arm A = AMG 706 125 mg PO daily continuously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 706 | Drug | Arm B - AMG 706 75 mg BID 2-weeks on and 1-week off |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Average change from baseline in gallbladder size (volume by ultrasound) | Anticipated 8 months of treatment with AMG 706 | |
| Average change from baseline in gallbladder function (ejection fraction) | Subject treatment with AMG 706 anticipated to be 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Average changes from baseline in gallbladder size (volume by CT scan) | Subject treatment with AMG 706 anticipated to be 8 months | |
| Maximum change from baseline in gallbladder size (volume) and function (ejection fraction) | Subject treatment with AMG 706 anticipated to be 8 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23679351 | Derived | Rosen LS, Lipton L, Price TJ, Belman ND, Boccia RV, Hurwitz HI, Stephenson JJ Jr, Wirth LJ, McCoy S, Hei YJ, Hsu CP, Tebbutt NC. The effect of different dosing regimens of motesanib on the gallbladder: a randomized phase 1b study in patients with advanced solid tumors. BMC Cancer. 2013 May 16;13:242. doi: 10.1186/1471-2407-13-242. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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| ID | Term |
|---|---|
| C000625785 | motesanib diphosphate |
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| AMG 706 |
| Drug |
Arm C - 75 mg BID 5-days on, 2-days off |
|
| AMG 706 | Drug | AMG 706 125 mg daily continuously (Arm A) |
|
| Change in gallbladder size (volume) and function (ejection fraction) between the last on-treatment measurement and the last available off-treatment measurement | Subject treatment with AMG 706 anticipated to be 8 months |
| Objective response in subjects with measurable disease at baseline | Subject treatment with AMG 706 anticipated to be 8 months |
| Pharmacokinetics of AMG 706 monotherapy | 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 | 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 | Subject treatment with AMG 706 anticipated to be 8 months |