Trials / Terminated
TerminatedNCT03541369
Safety, Tolerability, PK, PD, and Efficacy of AMG 427 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia
A Phase 1 First-In-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 427 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia.
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 64 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Evaluate the safety and tolerability of AMG 427 in adult subjects with relapsed/refractory (R/R) acute myeloid leukemia (AML). Estimate the maximum tolerated dose (MTD) and / or a biologically optimal dose (eg, recommended phase 2 dose \[RP2D\]).
Detailed description
Evaluate the safety and tolerability of AMG 427 in adult subjects with relapsed/refractory AML. Estimate the maximum tolerated dose (MTD) and / or a biologically optimal dose (eg, recommended phase 2 dose \[RP2D\]). Approximately 80 subjects will be enrolled.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AMG 427 | AMG 427 will be administered as an intravenous (IV) infusion in adult subjects with relapsed/refractory AML. |
Timeline
- Start date
- 2018-09-14
- Primary completion
- 2023-02-21
- Completion
- 2023-02-21
- First posted
- 2018-05-30
- Last updated
- 2024-10-10
- Results posted
- 2024-10-10
Locations
16 sites across 6 countries: United States, Australia, Canada, Germany, Japan, South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03541369. Inclusion in this directory is not an endorsement.