Study identifier:AMP-224-01
ClinicalTrials.gov identifier:NCT01352884
EudraCT identifier:N/A
CTIS identifier:N/A
-
cancer
Phase 1
No
AMP-224
All
44
Interventional
18 Years +
Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Aug 2016 by MedImmune, LLC
MedImmune, LLC
GlaxoSmithKline
This is a Phase 1, open-label, multi-center, first time in human study of AMP-224 in adult patients with cancer that is not responding to standard therapy. This study will be conducted in two stages consisting of a Dose-Escalation stage and an Expansion Stage.
Location
Location
Detroit, Michigan, United States, 48201
Location
Nashville, Tennessee, United States, 37203
Location
Huntersville, NC, United States, 28078
Location
New York, NY, United States, 10065
Arms | Assigned Interventions |
---|---|
Experimental: Stage 1 Stage 1 will identify the recommended Stage 2 dose using a dose-escalation process. Dose-escalation will continue until either a maximum tolerated dose is established, or a therapeutic dose is reached. | Drug: AMP-224 Escalating doses of AMP-224 |
Experimental: Stage 2 Stage 2 will further explore the safety, pharmacokinetics, and preliminary clinical activity of AMP-224 in at least one tumor type based on pharmacodynamic assessments and clinical activity emerging from the Dose-Escalation Phase. Tumor tissue and blood specimens will be evaluated for pharmacodynamic markers/activity at specified timepoints throughout the study. | Drug: AMP-224 Stage 2 will further explore the safety, pharmacokinetics, and preliminary clinical activity of AMP-224 in at least one tumor type based on pharmacodynamic assessments and clinical activity emerging from the Dose-Escalation Phase. Tumor tissue and blood |
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