NCT02520427

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

A Phase 1 First-in-human Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 330 Administered as Continuous Intravenous Infusion in Subjects With Myeloid Malignancies

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapsed/Refractory AML
• Minimal Residual Disease Positive AML
• Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	AMG 330	0.5 µg/day - 1.6 mg/day cIV infusion administered in cycles from 14 to 28 days.

Timeline

• Start date: 2015-08-31
• Primary completion: 2022-01-09
• Completion: 2022-01-09
• First posted: 2015-08-11
• Last updated: 2024-07-31
• Results posted: 2024-07-31

Locations

11 sites across 4 countries: United States, Canada, Germany, Netherlands