Trials / Terminated
TerminatedNCT02675452
AMG 176 First in Human Trial in Participants With Relapsed or Refractory Multiple Myeloma and Participants With Relapsed or Refractory Acute Myeloid Leukemia
A Phase 1 First in Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 176 in Subjects With Relapsed or Refractory Multiple Myeloma and Subjects With Relapsed or Refractory Acute Myeloid Leukemia
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 141 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The main objectives are to evaluate the safety and tolerability of AMG 176 monotherapy in participants with relapsed or refractory multiple myeloma and participants with relapsed or refractory acute myeloid leukemia.
Detailed description
This is a Phase 1, first-in-human, multicenter; non-randomized, open-label and dose-exploration study of AMG 176 administered IV in participants with relapsed or refractory multiple myeloma and participants with relapsed or refractory acute myeloid leukemia The study will be conducted in five parts.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AMG 176 | Study Drug |
| DRUG | Azacitidine | Non-investigational product |
| DRUG | Itraconazole | Non-investigational product |
Timeline
- Start date
- 2016-06-13
- Primary completion
- 2024-05-27
- Completion
- 2024-05-27
- First posted
- 2016-02-05
- Last updated
- 2025-07-09
- Results posted
- 2025-07-09
Locations
24 sites across 5 countries: United States, Australia, Canada, Germany, Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02675452. Inclusion in this directory is not an endorsement.