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NCT03465540 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, Pharmacokinetics and Efficacy of AMG 397 in Subjects With Selected Relapsed or Refractory Hematological Malignancies
A Phase 1 study, sponsored by Amgen.
- Terminated
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT03465540: Clinical Trial Phase 1 study, sponsored by Amgen.
NCT03465540 is a Phase 1 study that was terminated before completion, run by Amgen. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03465540, a Phase 1 study, was terminated before completion, sponsored by Amgen.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
Evaluate the safety and tolerability of AMG 397. Estimate the maximum tolerated doses (MTDs) and/or biologically active doses.
Primary Outcome
DLTs were defined as specific adverse events (AEs) that occurred in a participant during the DLT evaluation period (Day 1 to Day 28), that the investigator assessed as related to AMG 397. The grading and severity of AEs were based on the guidelines provided in the common terminology criteria for adverse events (CTCAE) version 4.03.
Interventions
- DRUG Azacitidine
- DRUG Dexamethasone
- DRUG AMG 397
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2018-08-17 |
| Est. Completion | 2019-07-25 |
| Phase | Phase 1 |
Why NCT03465540 stopped before completion
NCT03465540 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 3 interventions - of which Azacitidine is the first listed.
NCT03465540 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03465540 about?
NCT03465540 is a clinical study titled "Safety, Tolerability, Pharmacokinetics and Efficacy of AMG 397 in Subjects With Selected Relapsed or Refractory Hematological Malignancies". Evaluate the safety and tolerability of AMG 397. Estimate the maximum tolerated doses (MTDs) and/or biologically active doses.
What is the current status of trial NCT03465540?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2018-08-17. Estimated completion is 2019-07-25.
What interventions are being tested in trial NCT03465540?
The interventions under investigation include: Azacitidine (DRUG), Dexamethasone (DRUG), AMG 397 (DRUG).
Who is sponsoring clinical trial NCT03465540?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03465540's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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