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

NCT02291614 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2021-03-16

Study results available
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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.

Conditions

  • GI Adenocarcinoma

Interventions

DRUG

AMG 211

continuous intravenous infusion (cIV) infusion in cycles from 7 to 28 days

Sponsors & Collaborators

  • MedImmune LLC

    collaborator INDUSTRY

  • Amgen

    lead INDUSTRY

Principal Investigators

  • MD · Amgen

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Germany
  • Netherlands

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02291614 on ClinicalTrials.gov