Trials / Terminated
TerminatedNCT02291614
A Phase 1 Study of AMG 211 in Participants With Advanced Gastrointestinal Cancer
A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 211 Administered as Continuous Intravenous Infusion in Subjects With Relapsed/Refractory Gastrointestinal Adenocarcinoma
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AMG 211 | continuous intravenous infusion (cIV) infusion in cycles from 7 to 28 days |
Timeline
- Start date
- 2014-11-27
- Primary completion
- 2017-11-06
- Completion
- 2018-01-09
- First posted
- 2014-11-14
- Last updated
- 2021-03-16
- Results posted
- 2021-02-24
Locations
5 sites across 2 countries: Germany, Netherlands
Source: ClinicalTrials.gov record NCT02291614. Inclusion in this directory is not an endorsement.