Study Evaluating AMG 386 in Adult Patients With Advanced Solid Tumors
|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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00102830