Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2026-02-24 @ 10:15 AM
Study NCT ID:
NCT02520427
Status:
TERMINATED
Last Update Posted:
2024-07-31
First Post:
2015-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase 1 Study of AMG 330 in Subjects With Myeloid Malignancies
Sponsor:
Amgen
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Amgen strategic business decision to cancel following portfolio review, re-prioritization.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2014-004462-20 | EUDRACT_NUMBER | None | View |