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NCT03217838 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, Pharmacokinetics, and Efficacy of AZD2811 Nanoparticles as Monotherapy or in Combination in Acute Myeloid Leukemia Participants.
A Phase 1 study, sponsored by AstraZeneca.
- Terminated
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
NCT03217838: Clinical Trial Phase 1 study, sponsored by AstraZeneca.
NCT03217838 is a Phase 1 study that was terminated before completion, run by AstraZeneca. The registered enrollment target is 50 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03217838, a Phase 1 study, was terminated before completion, sponsored by AstraZeneca.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
Study Summary
This is a Phase I/II clinical study to determine the maximum tolerated dose (MTD), and schedule, safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD2811 monotherapy or with combination agent(s) in relapsed/refractory acute myeloid leukaemia (AML) participants or treatment-naïve AML participants not eligible for intensive induction therapy. In addition, the study will explore the potential clinical activity by assessing anti-tumour activity in participants. The study was terminated early as a result of AstraZeneca's strategic review across the AZD2811 programme. Part A data were collected for initial cohorts; the MTD/recommended Phase 2 dose (RP2D) dose and schedule of AZD2811 monotherapy or with combination agents were not determined. Part B of the study was not initiated
Primary Outcome
A DLT was defined as any adverse event (AE) not related to the underlying leukaemia requiring treatment interruption for \> 21 days, any Grade 5 AE, Grade 4 neutropenia or thrombocytopenia lasting \>= 42 days from start of cycle in absence of evidence of active leukaemia, any \>= Grade 3 non-haematological AE (except Grade 3 nausea, vomiting, mucositis, stomatitis or diarrhoea that was controlled within 4 days and Grade 3 elevations in alanine aminotransferase/ aspartate aminotransferase that re
Interventions
- DRUG Venetoclax
- DRUG Azacitidine
- DRUG AZD2811
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2017-07-31 |
| Est. Completion | 2021-03-25 |
| Phase | Phase 1 |
Why NCT03217838 stopped before completion
NCT03217838 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 3 interventions - of which Venetoclax is the first listed.
NCT03217838 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03217838 about?
NCT03217838 is a clinical study titled "Safety, Tolerability, Pharmacokinetics, and Efficacy of AZD2811 Nanoparticles as Monotherapy or in Combination in Acute Myeloid Leukemia Participants.". This is a Phase I/II clinical study to determine the maximum tolerated dose (MTD), and schedule, safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD2811 monotherapy or with combination agent(s) in relapsed/refractory acute myeloid leukaemia (AML) participants or treatment-naïve AML p...
What is the current status of trial NCT03217838?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2017-07-31. Estimated completion is 2021-03-25.
What interventions are being tested in trial NCT03217838?
The interventions under investigation include: Venetoclax (DRUG), Azacitidine (DRUG), AZD2811 (DRUG).
Who is sponsoring clinical trial NCT03217838?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03217838's enrollment target sits among peer trials
50 973rd of 2000 higher than 984 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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