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NCT01300026 · ClinicalTrials.gov registry record · Phase 1
AMG 319 Lymphoid Malignancy FIH
A Phase 1 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT01300026: Completed Phase 1 study, sponsored by Amgen.
NCT01300026 is a Phase 1 study that has completed, run by Amgen. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01300026, a Phase 1 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
This is a multi-center, phase 1, open-label first-in-human study of AMG 319 in subjects with relapsed or refractory lymphoid malignancies. This study consists of two parts. The dose exploration in part 1, studies cohorts of 3 subjects with relapsed or refractory lymphoid malignancies and uses a practical continuous reassessment model \[CRM\] to guide dose escalation and to define the MTD. The dose expansion in part 2 will enroll 20 subjects with CLL at a dose no higher than the MTD and further explore the safety, PK, and clinical activity of AMG 319 in this patient population.
Interventions
- DRUG AMG 319
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2011-04 |
| Est. Completion | 2016-12 |
| Phase | Phase 1 |
What the finished NCT01300026 record still lists
NCT01300026 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 1 intervention - of which AMG 319 is the first listed.
NCT01300026 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01300026 about?
NCT01300026 is a clinical study titled "AMG 319 Lymphoid Malignancy FIH". This is a multi-center, phase 1, open-label first-in-human study of AMG 319 in subjects with relapsed or refractory lymphoid malignancies. This study consists of two parts. The dose exploration in part 1, studies cohorts of 3 subjects with relapsed or refractory lymphoid malignancies and uses a prac...
What is the current status of trial NCT01300026?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2011-04. Estimated completion is 2016-12.
What interventions are being tested in trial NCT01300026?
The interventions under investigation include: AMG 319 (DRUG).
Who is sponsoring clinical trial NCT01300026?
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 NCT01300026's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 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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