A Phase 1 interventional study of AMG 386 in Tumors, sponsored by Amgen. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-08-20.
Sponsored by Amgen · Phase 1, Interventional, and Treatment
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.
9,359 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.
Browse Neoplasms studies →Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.
Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: - Have evaluable disease - Must be able to undergo MRI evaluation:
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.
No study locations are listed for this record.
This study is completed, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Amgen