Study Evaluating AMG 386 in Adult Patients With Advanced Solid Tumors
This study has been completed.
Information provided by:
First received: February 3, 2005
Last updated: August 19, 2010
Last verified: August 2010
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.
|Study Design:||Endpoint Classification: Safety Study
Primary Purpose: Treatment
|Official Title:||A Phase 1 Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of AMG 386 in Adult Patients With Advanced Solid Tumors|
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
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