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NCT04022785 · ClinicalTrials.gov registry record · Phase 1

PLX51107 and Azacitidine in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

A Phase 1 study, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 1
Development phase
43
Enrollment target

NCT04022785: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.

NCT04022785 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 43 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04022785, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
43 participants
Enrollment target

Study Summary

This phase I trial studies the side effects and best dose of PLX51107 and how well it works with azacitidine in treating patients with acute myeloid leukemia or myelodysplastic syndrome. PLX51107 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving PLX51107 and azacitidine may work better than azacitidine alone in treating patients with acute myeloid leukemia or myelodysplastic syndrome.

Primary Outcome

Toxicity type and severity will be summarized for each patient cohort using frequency tables. Per-treated analysis will be performed to include any patient who received the treatment regardless of the eligibility nor the duration or dose of the treatment received.

Interventions

  • DRUG Azacitidine
  • DRUG BRD4 Inhibitor PLX51107

Trial Details

FieldValue
Enrollment Target 43 participants
Start Date 2019-09-09
Est. Completion 2022-10-24
Phase Phase 1
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT04022785 record still lists

NCT04022785 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower).

The record links to 0 conditions, and to 2 interventions - of which Azacitidine is the first listed.

NCT04022785 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04022785 about?

NCT04022785 is a clinical study titled "PLX51107 and Azacitidine in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome". This phase I trial studies the side effects and best dose of PLX51107 and how well it works with azacitidine in treating patients with acute myeloid leukemia or myelodysplastic syndrome. PLX51107 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used i...

What is the current status of trial NCT04022785?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2019-09-09. Estimated completion is 2022-10-24.

What interventions are being tested in trial NCT04022785?

The interventions under investigation include: Azacitidine (DRUG), BRD4 Inhibitor PLX51107 (DRUG).

Who is sponsoring clinical trial NCT04022785?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04022785's enrollment target sits among peer trials

43 1100th of 2000 higher than 896 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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Source: ClinicalTrials.gov NCT04022785, the US trial registry maintained by the National Library of Medicine. NCT04022785 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.