drugset / Trial / NCT02520427

A Phase 1 Study of AMG 330 in Subjects With Myeloid Malignancies

NCT02520427 ↗

Phase 1 Terminated 95 enrolled Amgen
Non-randomizedSequentialOpen-labelTreatment

Summary

The purpose of this First-in-Human Phase 1 study is to determine if AMG 330 given as a continuous IV infusion is safe and tolerable in adult subjects that have myeloid malignancies, and to determine the maximum tolerated dose and/or a biologically active dose. The study will be conducted in multiple sites and test increasing doses of AMG 330. The safety of subjects will be monitored by intensive assessment of vital signs, electrocardiograms, physical examinations, and laboratory tests.

Timeline

Start
2015-08-31
Primary completion
2022-01-09
Completion
2022-01-09

Outcome

Outcome not reported

Stopped (Business): “Amgen strategic business decision to cancel following portfolio review, re-prioritization.”

Drugs

EvaluationDrugModalityDoseRoute
Subject ELUVIXTAMAB Monoclonal antibody 0.5 ug Intravenous
Subject ELUVIXTAMAB Monoclonal antibody 1.6 mg Intravenous