Study Evaluating AMG 386 in Adult Patients With Advanced Solid Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00102830|
Recruitment Status : Completed
First Posted : February 4, 2005
Last Update Posted : August 20, 2010
|Condition or disease||Intervention/treatment||Phase|
|Tumors||Drug: AMG 386||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase 1 Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of AMG 386 in Adult Patients With Advanced Solid Tumors|
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00102830