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The purpose of this study is to test the safety, tolerability and pharmacokinetic (PK) profile of AMG 386 after intravenous administration in adult subjects with advanced solid tumors.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 386 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events, clinically significant changes in laboratory results, ECG, and vital signs, to be measured throughout the study. | ||
| Pharmacokinetic Profile of AMG 386 - blood levels of AMG 386 to be measured throughout the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in DCE-MRI imaging results measured at baseline, Week 1, and Week 4. | ||
| Changes in blood levels of angiogenic cytokines measured at baseline, Day 3, Weeks 2, 4, 10, and every 8 weeks thereafter. |
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Inclusion Criteria: - Have evaluable disease - Must be able to undergo MRI evaluation:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22210018 | Derived | Lu JF, Rasmussen E, Karlan BY, Vergote IB, Navale L, Kuchimanchi M, Melara R, Stepan DE, Weinreich DM, Sun YN. Exposure-response relationship of AMG 386 in combination with weekly paclitaxel in recurrent ovarian cancer and its implication for dose selection. Cancer Chemother Pharmacol. 2012 May;69(5):1135-44. doi: 10.1007/s00280-011-1787-5. Epub 2012 Jan 1. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C551398 | trebananib |
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| Anti-AMG 386 antibody formation measured at baseline, weeks 2, 4, 6, and every 4 weeks thereafter. |
| Tumor response measure by CT scan at baseline, Week 4, and every 8 weeks thereafter. |