drugset / Trial / NCT02291614

A Phase 1 Study of AMG 211 in Participants With Advanced Gastrointestinal Cancer

NCT02291614 ↗

Phase 1 Terminated 45 enrolled Amgen MedImmune LLC · collab
Non-randomizedSequentialOpen-labelTreatment

Summary

The purpose of this Phase 1 study is to determine if AMG 211 given as a continous intravenous (IV) infusion is safe and tolerable in adult participants that have advanced gastrointestinal adenocarcinoma. The study will be conducted in multiple sites and test increasing doses of AMG 211. The safety of participants will be monitored by intensive assessment of vital signs, electrocardiograms, physical examinations, and laboratory tests. Efficacy will be assessed by the usual imaging procedures and their interpretation.

Timeline

Start
2014-11-27
Primary completion
2017-11-06
Completion
2018-01-09

Outcome

Outcome not reported

Stopped (Business): “The study was terminated because of immunogenicity and business decision.”

Drugs

EvaluationDrugModalityDoseRoute
Subject AMG 211 Protein / enzyme biologic 200 ug Intravenous
Subject AMG 211 Protein / enzyme biologic 400 ug Intravenous
Subject AMG 211 Protein / enzyme biologic 800 ug Intravenous
Subject AMG 211 Protein / enzyme biologic 1600 ug Intravenous
Subject AMG 211 Protein / enzyme biologic 3200 ug Intravenous
Subject AMG 211 Protein / enzyme biologic 6400 ug Intravenous
Subject AMG 211 Protein / enzyme biologic 12800 ug Intravenous

Indications