Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 1 study that has completed, run by Amgen. The registered enrollment target is 28 participants.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01300026
The ClinicalTrials.gov registry entry for NCT01300026 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which AMG 319 is the first listed.
NCT01300026 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.