drugset / Trial / NCT02291614
A Phase 1 Study of AMG 211 in Participants With Advanced Gastrointestinal Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |